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medtech (31)

Bronze Level Contributor

In a test of 30 popular mobile health apps, a cybersecruity analyst found that all of them had API vulnerabilities.  Potential breaches would allow for unauthorized access of patient records.

While most patients expect their health information to be secure when they download an app the reality might often be the opposite.

Several widely-used mobile health apps have basic security flaws that could leave them vulnerable to attacks, according to a report released yesterday by Knight Ink and mobile app API security company Approov.

Alissa Knight, a cybersecurity analyst and partner at Knight Ink, tested 30 popular mobile health apps for potential security vulnerabilities. All 30 were vulnerable to API attacks that could expose patient records.

Though the report didn’t disclose the names of the apps that were tested, it’s worth noting that they weren’t just niche tools created by small teams.  The apps tested had an average of 772,619 downloads, and the companies that developed them had about 15,000 employees on average, and annual revenues between $600 million and $8 billion.

For example, they were the types of apps that hospitals would tell patients to download to access their lab results or records after a visit, Knight said in a phone interview.

“They were so poorly written that, using freely downloadable tools, I could change the data that I was requesting to be another patient’s records,” she said.

Application programming interfaces (APIs) serve as intermediaries processing requests for information from an app and retrieving that information from a database. Knight tested them for several vulnerabilities, including whether she could access another user’s data or breach an account.

All of the APIs were vulnerable to Broken Object Level Authorization (BOLA) vulnerabilities, that allowed her to access patient information that her account shouldn’t have been able to access. Knight used the analogy of a coat check to explain it:

One person checks their jacket, and gets a ticket with the number 18, while the person next in line gets a ticket with the number 17. By changing the number 7 to an 8, the “hacker” would be able to take the other person’s coat.

Except in this case, she was able to access patient records, lab results, x-rays, allergies, and personally identifiable information, including social security numbers.

“I was very surprised. I knew I would find BOLA vulnerabilities in mobile health apps and APIs, but I didn’t know it would be this systemic,” Knight said.

Half of the APIs she tested allowed her to access other patients’ pathology results, x-rays and other clinical information. Half of them also allowed her to access records for patients that had been admitted to the hospital as inpatients.

She also found that 77% of the apps had hard-coded API keys, and 7% contained hard-coded usernames and passwords, which would allow someone who could view the app’s code to access those users’ accounts. By accessing one hospital’s login, she was able to access 10s of thousands of patient records.

“This is really low-hanging fruit,” she said. “It requires very little sophistication, very little money. One of the tools I was using was freely available, and the apps are available in the app store for free. All you have to do is register for an account.”

The problem of cybersecurity is not limited to mobile health apps alone.

A separate survey of executives at medtech companies found that 80% of them had suffered at least one cyberattack in the past five years. The survey, conducted by platform security company Irdeto, included medical device manufacturers, digital and mobile health companies and telehealth providers.

Knight said that cybersecurity must be a consideration while code is still being written, instead of trying to secure a project while it is available to the general public. Companies should also bring in outside experts to test them before they go to market.

“We need to do better about securing (health data) and making sure it’s a lot more difficult for adversaries to get access to it,” she said. “For me, being a vulnerability researcher is so important — making sure we’re holding these vendors’ feet to the fire and making sure they’re following best practices, because this is our most sensitive data.”

Originally published by
Elise Reuter | February 10, 2021
MedCity News

Photo credit: Getty Images, weerapatkiatdumrong

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Bronze Level Contributor

4 key trends for medtech in 2021

Image: Adeline Kon/MedTech Dive

COVID-19 challenges, and opportunities, will continue to impact companies this year.

The calendar signals a new year but the medtech industry in 2021 will feel the lingering effects, both positive and negative, from the global coronavirus pandemic. 

With the resurgence of the virus and emergence of new more contagious strains, COVID-19 will have major impacts on companies as much as 2020, albeit with the benefit of insights gleaned from the historic year and its unprecedented business environment.     

Earlier this month, medtech and diagnostics companies gathered virtually to discuss 2021 prospects at J.P. Morgan's annual healthcare conference. Executives painted a mixed picture with the first half of the year looking bumpier than the second half.

Not surprisingly, many companies are not providing 2021 guidance due to the uncertainty caused by COVID-19. However, Craig-Hallum analyst Alex Nowak noted recently that most of the companies his firm covers have spoken optimistically about a full recovery taking hold in 2021.

"The recovery though will not be outsized year/year growth in 1Q21-3Q21, but instead consistent levels of quarter/quarter gains throughout the year," Nowak wrote in a research note.    

Below are four big trends to watch in 2021 for the industry.

Elective procedures remain under pressure

Wall Street expects declines in elective care in the near term to continue as coronavirus cases keep rising. While the rollout of vaccines will likely help volumes, procedure comebacks are not expected until the second half of 2021, according to J.P. Morgan analysts.

To be sure, there will be winners and losers financially in this scenario.

"The ones affected were, to no surprise, those tied to elective procedures or were hospital-oriented," according to Nowak. "The real weakness was procedures that were not entirely critical (or critical and could be shifted outside the hospital), nor driven by higher income, such as spine surgery."

While Moody's expects procedure volumes will continue to recover in 2021 as patients who deferred procedures to treat chronic illnesses return to their healthcare providers, the investor service predicts demand will be volatile based on the spread of COVID-19.

Moody's expects transcatheter aortic valves, a key revenue driver, "will return to double-digit growth" for leaders such as Edwards Lifesciences and Medtronic.

Edwards on Wednesday reported that U.S. TAVR sales were actually down lower than Wall Street's expectations in the fourth quarter, and recent procedure slowdowns are expected to spill into 2021. However, CEO Michael Mussallem believes that the company will still hit its guidance of growing TAVR globally by 15-20% this year.

Medtronic warned earlier this month that due to the COVID-19 surge the company now expects overall business to be "roughly flat" this quarter, on an organic basis, instead of flat to slightly up. 

CEO Geoff Martha noted that Medtronic didn’t see much of a negative impact from the surge in coronavirus cases in October, November and even the first half of December. However, the medtech giant started to see "some impact" starting over the holidays. 

Nonetheless, Martha called hospitals more experienced at handling the current COVID-19 surge while maintaining capacity for non-coronavirus patients. He cited pockets in the U.S. and Europe "where it has slowed down a bit" in recent weeks.  

"It is more of an elective case pullback issue versus some other issue that's unique to Medtronic," Martha said. "Based on the feedback that we're getting from hospitals, we remain optimistic that this is going to be short lived."   

However, executives from Baxter and Boston Scientific appear to be more concerned about the ability of some hospitals to manage the coronavirus stresses on their health systems as the number of cases continue to rise.  

Baxter CFO Jay Saccaro at the recent J.P. Morgan conference described the current coronavirus surge as "volatile" and that Baxter will be taking "as much time as we possibly can to put together guidance." 

Boston Scientific expects a rebound in procedure volumes this year. However, the company is not providing 2021 guidance at this time. CEO Mike Mahoney told analysts that he expects “some COVID impact” and “softness” in the first quarter “given the market environment.” However, Mahoney said with the increasing rollout of COVID-19 vaccines in 2021 the situation will “improve each month.”    

Another banner year for COVID-19 testing

Demand for COVID-19 testing will continue to accelerate over the next year, with volumes remaining high until vaccines are widely distributed, according to Moody's.

"This will benefit companies that sell diagnostic tests, like Abbott Laboratories and Becton Dickinson, as well as life science companies that provide reagents used in these tests like Thermo Fisher Scientific," Moody's analysts wrote in their 2021 outlook for the global healthcare sector. 

Despite the rollout of coronavirus vaccines, Abbott, Hologic and Quidel are ramping up their manufacturing capabilities in anticipation of another banner year for COVID-19 testing. CEOs from the diagnostic makers laid out their coronavirus test plans earlier this month at J.P. Morgan. 

Hologic CEO Stephen MacMillan said the company has more than doubled its molecular diagnostic manufacturing capacity and is investing to more than triple capacity from 25 million tests in the fourth quarter of 2020 to 75 million tests per quarter by the second quarter of 2022. 

"Everybody thought as soon as vaccines came, testing is going to go away. I think everybody is now seeing the realities of rolling out vaccines, of distribution chains. There is so much more complexity," MacMillan said. "This market, we believe, continues to grow and continues to be strong. And while it will certainly come down at some point, we believe it's going to be stronger for longer."  

Abbott CEO Robert Ford said he expects high demand and volume for tests throughout 2021. The company is near completion of capacity expansion at U.S. manufacturing sites, which Ford estimated will enable production of tens of million more of its BinaxNOW COVID-19 antigen tests per month for sale to schools, workplaces, and pharmacies.

Quidel's QuickVue SARS test, a pregnancy test-style antigen diagnostic that like Abbott's BinaxNOW delivers results in minutes, is the focus of an at-home coronavirus testing effort.   

"We are now anticipating a QuickVue SARS OTC at-home approval, which would not require a prescription," CEO Doug Bryant said at the conference. "We think it's the future of the company."  

Early in 2021, Quidel hopes to have QuickVue tests available as OTC at home productsThe company plans to manufacture as many of the diagnostics that it can this year.  

Tuck-in acquisitions poised to take off

While M&A slowed last year due to the coronavirus pandemic, a report from consultancy EY predicts medtech dealmaking to jump in 2021 as companies are armed with a record high of roughly $500 billion in financial firepower. So far this year, the industry has seen a flurry of activity.

Hologic kicked the trend off in January with an acquisition of Somatex Medical for $64 million, and less than a week into 2021 added its second tuck-in with the acquisition of Biotheranostics for $230 million. PerkinElmer struck a deal to buy tuberculosis test provider Oxford Immunotec for $591 million and Thermo Fisher Scientific announced it will acquire privately-held molecular diagnostic maker Mesa Biotech for $450 million in cash.

The biggest deal over the first weeks of January was Steris' purchase of Cantel Medical in a cash and stock acquisition of approximately $4.6 billion, followed by Boston Scientific's announcement that it will purchase cardiac monitoring company Preventice Solutions in a $925 million deal and Philips' plans to acquire Capsule Technologies for a cash consideration of $635 million.   

At Boston Scientific, strategic tuck-ins remain the company’s “number one priority” when it comes to capital deployment with a focus on high-growth adjacent markets, CEO Mike Mahoney said earlier this month, noting $1.9 billion in cash on hand as of the end of last year. He also said the company will continue to be active with its venture capital portfolio “which has historically served as well as a nice pipeline” for M&A.     

Medtronic's Martha said that the medtech giant plans to continue to look for M&A opportunities in 2021 after the company last year accelerated its momentum for tuck-in acquisitions, announcing seven such deals with a combined total consideration of over $1.6 billion. 

Baxter CEO Joe Almeida said the company continues to "think very seriously" and to "evaluate" M&A this year. "I'm not in a position to tell you affirmatively that 2021 is the year of M&A," he remarked, though it is part of the medtech's playbook.

While some companies will look for tuck-in acquisitions, a handful of deals over $1 billion should be expected, according to John Babbitt, EY's MedTech leader for the Americas. In addition, EY sees several subsectors as top targets in 2021 for M&A activity including diagnostics, digital health, and remote patient monitoring.  

Digital, remote tech adoption to grow

Last year, the need to create safe physical distances between healthcare workers and COVID-19 patients prompted medtechs to modify how their devices are used, including remote programming and monitoring. This year, executives say they will continue to adopt many of the features, which are becoming permanent offerings.

Martha said Medtronic will be increasingly incorporating the technology across its product portfolio.  

“You are already seeing this with the advances we have made in remote monitoring and remote programming of many of our devices. We have added advanced capabilities to cardiac rhythm devices, diabetes insulin pumps, and ventilators, just to name a few,” Martha said.

Abbott's Ford said his company is continuing to adopt remote care and digital health technologies as a result of the pandemic, which has accelerated the trend. However, Ford made the case at J.P. Morgan that the benefits of such tech goes beyond just COVID-19.

"It allows for much more proactive management. We see that in some of our portfolio. It can decrease the response time, especially if you've got like an urgent care situation. It can really bring that response time down lower, cuts up a lot of the logistical issues, the challenges of in-person, and then ultimately can lead to lower healthcare cost," Ford said.

He pointed to the FDA's approval in July of the Gallant implantable cardioverter defibrillator family of devices to help manage heart rhythm disorders, which offer Bluetooth technology and a new patient smartphone app for improved remote monitoring.   

Boston Scientific in 2021 is also looking to build on “healthcare digital adoption” by accelerating and expanding its remote technology capabilities, according to CEO Mahoney.  

The company has “leveraged COVID” to accelerate its digital investments and capabilities in such focus areas as clinical trials, customer engagement, mobile solutions, medical education and remote case support, Mahoney said. 

Boston Scientific’s initiatives include remote case support and virtual reality solutions, remote monitoring of clinical trials, as well as teleproctoring and virtual medical education.     

“We see these platforms as a key catalyst for growth and structural and cost savings opportunities over time, and continue to expand our footprints and these digital capabilities,” Mahoney added.   

Originally published by
Greg Slabodkin | January 29, 2021
Medtech Dive

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Gold Level Contributor

Getty Image

GE Healthcare, Medtronic and Philips are among the big medtechs investing in artificial intelligence and machine learning, technologies they contend hold potential for better diagnosing, managing and treating a wide variety of diseases and health conditions.

While medtechs are only starting out on their AI/ML efforts, they are developing, acquiring and implementing these technological capabilities, betting it will put them ahead of rivals to ultimately drive future growth.

"One of our core differentiators is our ability to take cutting-edge technology and apply it to medical technology," including AI, Medtronic CEO Geoff Martha said in October at the company's investor day.

"With the emergence of big datasets, combined with innovation in robotics, sensors, computational power and AI, some of the greatest advances in medical technology are unfolding right now," Martha said.

Martha's marketing tagline is that Medtronic is "putting the tech into medtech," an initiative that includes several technologies supporting its spine surgery portfolio such as robotics, navigation, advanced imaging and pre-operative planning aided by AI. Some Medtronic technology has been developed internally, while others are through partnerships and acquisitions.

Last month, the giant completed its 7 euros-per-share tender offer for French spinal surgery specialist Medicrea, four months after announcing the deal. Medtronic's interest in Medicrea appears to be driven largely by the company's AI.

Among Medicrea's key products is its UNiD ASI pre-procedure platform for surgeons that the company says uses predictive modeling algorithms to measure and digitally reconstruct a patient's spine. Medtronic execs contend the future of spine surgery is driven not just by metal implants and instrumentation, but also by a series of enabling technologies including robotics, navigation, advanced imaging and increasingly pre-operative planning aided by artificial intelligence.

The Medicrea buy means Medtronic is able to tap an AI database of more than 5,000 surgical cases. With the acquisition completed, Medtronic claims it's the first company in spinal surgery offering AI-driven planning, personalized implants and robot-assisted delivery.

Similarly, Philips' strategy is to lead in health technology "on the back" of market trends such as "higher precision" diagnosis through AI and workflow informatics. The Dutch healthtech giant on Friday announced a $2.8 billion cash deal to buy Bio Telemetry, which specializes in remote cardiac diagnostics and monitoring, with portfolios in wearable heart monitors and AI-based data analytics and services.

Philips' Diagnosis & Treatment business is focused on growing its core of AI-enabled informatics to help clinicians identify actionable insights out of the tsunami of clinical data.

Originally published by
Greg Slabodkin | December 22, 2020
Medtech Dive

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Silver Level Contributor

Pixabay

  • GE medical imaging devices used by hospitals around the world, including CT scanners and MRI machines, have a cybersecurity vulnerability potentially putting the operation of these systems and the health data contained on them at risk, according to services firm CyberMDX.
  • The vulnerability, discovered by the firm in May and reported at the time to GE, also impacts certain workstations and imaging devices used in surgery, according to the firm's head of research Elad Luz, who said the medtech giant has been working with customers for most of the year to fix the widespread problem. 
  • GE Healthcare is not aware of any unauthorized access to data or cyber incidents in a clinical situation in which the potential vulnerability has been exploited by hackers. A spokesperson said the company conducted a risk assessment and concluded there is no patient safety concern. However, the U.S. Cybersecurity and Infrastructure Security Agency has given the vulnerability a so-called CVSS score of 9.8 out of 10 (critical severity).
  • Dive Insight:

The vulnerability, dubbed MDhex-Ray, potentially impacts dozens of GE's radiology product models including CT scanners, MRI and PET machines, as well as mammography and ultrasound devices, according to CyberMDX, which says it is working with GE and CISA to mitigate potential breaches of the hospital systems.

The flaw could allow hackers to gain control of the imaging systems and get access to sensitive patient health information, CyberMDX's Luz warned, noting that GE is a "very popular vendor" for hospital imaging machines.

"They are crucial devices for clinical decision-making," Luz said. "Their downtime is also very expensive" for hospitals and other healthcare facilities should they lose machine functionality.    

For a cybercriminal to exploit these vulnerabilities and do potential damage, they must first gain access to a healthcare delivery organization’s network. However, if exploited, these vulnerabilities could allow an attacker to gain access to affected devices in a way that is comparable to that of a remote GE service user.

"A successful exploitation could expose sensitive data such as a limited set of patient health information (PHI) or could allow the attacker to run arbitrary code, which might impact the availability of the system and allow manipulation of PHI," according to CISA's advisory.

GE has identified mitigations and will take proactive measures to ensure proper configuration of the product firewall protection and change default passwords on impacted devices where possible, the advisory notes. 

"We are providing on-site assistance to ensure credentials are changed properly and confirm proper configuration of the product firewall. Additionally, we are advising the facilities where these devices are located to follow network management and security best practices," a GE Healthcare spokesperson said in an email statement.

The company insists the vulnerability only impacts a single-digit percentage of its customer-installed base of medical imaging and ultrasound devices.

However, Luz said that "given that there are so many devices affected" by the vulnerability it has been "extremely challenging" for GE to conduct a risk assessment for all the impacted products. As a result, he contends GE's customers need to be proactive in taking their own actions to mitigate the problem.

CISA recommends using network security best practices including ensuring proper segmentation of the local hospital network and create explicit access rules based on source/destination IP/port for all connections, including those used for remote support. The agency says specific ports to consider may include those used for TELNET, FTP, REXEC, and SSHtilize IPSec VPN and explicit access rules at the Internet edge before forwarding incoming connections to the local hospital network.     

Originally published by
Greg Slabodkin | December 8, 2020
Medtech Dive

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Platinum Level Contributor

Thankful for Biopharma Breakthroughs

JAAGNet Comment:

We believe during these tough times, people and companies step up and understand the urgent need to go above and beyond. Although its been a pretty tough year with not a lot (if any) positive news there has been a lot of  people and bsuinesses working really hard to tackle  Covid-19, whether it has been in the area of theraputics and/or vaccines. The following article is a great summary of the breakthoughs that have been made and it shows us hope and promise that we can knock down the impacts this virus could have had on our global society.  Peter

 >>

For so many, 2020 has been a bleak year filled with uncertainty and anxiety directly related to the COVID-19 pandemic that has surged across the globe and led to the deaths of more than 1.4 million people, including close to 260,000 in the United States.

Despite the constant need for social distancing, mask-wearing, and the isolation and economic uncertainty that resulted from the outbreak, there is still much to be thankful for when families gather around a virtual table to break bread and carve the turkey this year. And one uniting bit of thankfulness the global community can share in is the prowess of the international pharmaceutical industry displayed to address COVID-19. Following the outbreak that originated in China, then spread across Asia and into Europe, the pharmaceutical industry pivoted on a dime to tackle the global threat. Ongoing research was put on the backburner and scientists began to focus on understanding the virus and assessing what medications could be used against it. The virus was also sequenced and hundreds of vaccine projects were initiated. The industry, along with scientists from various government agencies and academic institutions joined together in a united front against the global pandemic.

And those efforts are now beginning to pay off. In Russia and China, vaccines are already being distributed to front-line workers and manufacturing is ramping up for broader distribution. In the west, we are just weeks away from seeing the first coronavirus vaccine receive Emergency Use Authorization. The mRNA vaccine candidate developed by Pfizer and Germany-based BioNTech demonstrated 95% efficacy in clinical trials. The U.S. Food and Drug Administration (FDA) will review the data on Dec. 10.

When that medication is greenlit (as it most likely will be), the limited number of vaccines currently available will roll out within 24 hours and inoculation will begin. Fortunately, more vaccines will likely see approval in the United States and Europe, which means more people will receive some protection against the virus. Moderna reported vaccine efficacy of 94.5% and earlier this week, AstraZeneca also announced 90% efficacy from its vaccine candidate. Novavax and Johnson & Johnson are expected to release data soon, as will Merck and other companies.

The vaccine approvals are the proverbial light at the end of the tunnel that is COVID-19. High rates of inoculation will lead to herd immunity against the virus and that is something for which to be thankful.

But, it’s not just vaccines that have been developed for COVID-19. The FDA recently approved two antibody treatments for the virus, Eli Lilly’s bamlanivimab and Regeneron’s REGN-COV2, which had previously been used to treat the COVID-19 diagnosis of President Donald Trump. Both of the antibody treatments do have limits for their use. They are not meant for COVID-19 patients who require supplemental oxygen or are on ventilators.

Gilead Sciences' remdesivir broke through as the first COVID-19 drug to receive full approval from the FDA as a medication that can shorten the time of infection for infected patients. Despite its approval, Remdesivir has received a rocky reception, with the World Health Organization recommending against its use due to limited capabilities. Other drugs have also received similar receptions over the course of the pandemic. While remdesivir has clinical data supporting its approval, other medications such as hydroxychloroquine have only anecdotal data backing up any efficacy against the virus. Still, those COVID-19 patients who have benefited from the treatments are surely thankful for any edge against the virus they received.

COVID-19 has certainly dominated our landscape over the past nine months, but other illnesses continue to negatively impact the human condition. COVID research has been a primary focus, but that has not put a halt to the development of treatments for other diseases, including rare diseases.

This week, Alnylam won approval for Oxlumo (lumasiran), the first drug approved by the FDA for primary hyperoxaluria type 1, an ultra-rare genetic disease that causes deposits of calcium oxalate crystals to form in the kidneys and urinary tract, which can lead to painful and recurrent kidney stones, nephrocalcinosis, progression to kidney failure and system organ dysfunction. Also this week, the FDA approved Eiger PharmaceuticalsZokinvy, the first drug approved to treat Hutchinson-Gilford Progeria Syndrome and processing-deficient Progeroid Laminopathies. The two genetic diseases cause premature, rapid aging that dramatically decreases the lifespan of children affected. In June, Novartis became the first company to the finish line with a treatment for Adult-Onset Still’s Disease (AOSD), a rare auto-inflammatory disease of unknown origin. Ilaris (canakinumab), was previously approved for Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.

These approvals and others not mentioned that improve quality of life and stave off premature death are all things the pharmaceutical industry and its countless, dedicated employees have provided for which we should be thankful.

Originally Published: Nov 26, 2020 By Alex Keown BioSpace

Original article can be found here

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Gold Level Contributor

Jacob Bell / BioPharma Dive

The latest batch of breakthrough device designations from FDA support an array of medtech innovations, from a novel treatment for sleep apnea to a tissue regeneration technology designed to aid spinal cord injury patients. Several technologies designated within the past month are diagnostics, with two targeting breast cancer and one designed to improve the diagnosis of a deadly gastrointestinal condition in premature infants. 

FDA's Breakthrough Devices Program aims to speed development and review of technology that could offer a better treatment for life-threatening or debilitating disease.

D Path last week said it received a breakthrough designation for a computer-aided diagnostic platform that uses digitized histopathology images to better determine breast cancer characteristics such as invasiveness and grades. The software-as-a-medical-device platform is designed to make clinical grade predictions from breast biopsy and resection images to improve diagnostic accuracy.

According to the Newton, Massachusetts-based company, the device reduces the error rate on biopsies obtained before surgery from 20% to less than 5%. The technology incorporates statistical physics and tumor biology to identify digital cancer biomarkers, aiding in treatment selection.

On the same day that 4D Path announced its breakthrough device designation, Lumicell, a fellow Newton medtech, said it received FDA's drug center's fast-track designation for its LUM imaging system to detect and remove cancerous tissue in the treatment of breast cancer. Lumicell said it received the special status with rolling review by FDA, augmenting its previously granted breakthrough device designation for breast cancer and all solid tumors.

The system allows surgeons to see and remove residual cancer in real-time, focusing on the cells left behind in the surgical cavity rather than on the lumpectomy specimen, with the aim to reduce the risk of second surgeries and cancer recurrence. Lumicell said it is continuing enrollment in its breast cancer pivotal trial and, with rolling review, will be able to submit modules for a New Drug Application with FDA as they are ready.

Also in mid-November, Louisiana State University announced that a technology to diagnose necrotizing enterocolitis, an often fatal condition in premature infants, gained a breakthrough device designation. Called NECDetect and invented by professor Sunyoung Kim, the noninvasive biomarker test is performed on stool samples. There is no clinical test that has been established as the gold standard to diagnose NEC. The new test identifies 93% true positives and 95% true negatives, according to LSU. Kim has started a spinout company to further develop and commercialize the product.

Originally published by
Susan Kelly | November 24, 2020
Medtech Dive

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Gold Level Contributor

The first quarter of 2020 was the slowest period for medtech IPOs in years, with just one company listing to raise $16 million. Activity picked up over the summer, when as many companies went public in one week as listed over the first five months of the year. The resurgence of activity was driven by one sector: Cancer testing. 

AnPac Bio-Medical Science, a Sino-American cancer screening company, became the first medtech to list on Nasdaq this year in January but only after downsizing its offering and pricing at the bottom of its target range. The stock has fallen more than 60% since the IPO. 

That marked the highpoint of the first quarter. With COVID-19 disrupting operations and roiling financial markets, no other medtech companies completed Nasdaq IPOs in the first quarter.

The tide turned in June when a flurry of cancer diagnostic companies went public. Buoyed by strong support from existing investors, Burning Rock, a Chinese cancer diagnostics company, priced an IPO above the target range. The next week, Genetron, another Chinese cancer testing business, smashed its target range and upsized its offering. Progenity, a U.S. provider of prenatal and cancer risk tests, priced its IPO at the midpoint of the range on the same day as Genetron listed.

Amid that activity, ArcherDX filed to raise $100 million to bring its tumor profiling test to market. The IPO was aborted when ArcherDX agreed to accept a cash-and-stock buyout bid from Invitae.

The cancer diagnostics sector was deprived of a showpiece 2020 IPO when Illumina made an offer to buy Grail weeks after the screening business filed to go public. The takeover is yet to close but as it stands Grail is set to rejoin its parent company rather than list on Nasdaq.

The cancer testing companies that did go public have had mixed fortunes. As it stands, Burning Rock’s stock has fared best, typically trading around $10 above its $16.50 offering price. The stock closed last week at $26.50. Genetron, in contrast, has rarely traded close to its $16 offering price and closed last week at $11.51. Progenity has had a similar experience, pricing at $15 but spending most of its time on public markets below $10.

Companies remain interested in going public, though. Earlier this month, Biodesix filed to raise $75 million to support commercialization of a roster of blood-based tests designed to assess the risk of lung cancer and measure tumor mutations and assess the patient’s immune system after a diagnosis. Biodesix also provides COVID-19 molecular and serology tests.

Non-cancer medtech IPOs accelerate

The rhythm of IPOs in the broader medtech industry in 2020 has followed a similar pattern to that of the cancer testing niche. Lyra Therapeutics became the first medtech company to list on Nasdaq in 2020 at the start of May, when it raised $56 million to develop products based on its bioresorbable polymeric matrix technology. 

Venous disease specialist Inari Medical pulled off an upsized IPO later in May and was joined on Nasdaq by kidney disease diagnostic player RenalytixAI in July. Acutus Medical priced its IPO in August, securing $159 million to support work on the diagnosis and treatment of cardiac arrhythmias.

The trickle of IPO activity seen over the summer accelerated significantly as the fall approached. Portable dialysis startup Outset Medical raised $242 million in September, after which Pulmonx and Aziyo Biologics priced IPOs in quick succession. Among those offerings, digital health startup G Medical Innovations and spinal surgery player Spine Elements set their target ranges. 

With most of the non-cancer medtech IPOs happening in the past 10 weeks, there is a limited set of data to assess how companies are faring on public markets. As it stands, LyraRenalytixAI and Aziyo are trading between 12% and 26% below their IPO prices. The other four companies are well above their IPO prices. 

Inari is leading the way, having seen its share price soar 281% in its short time on public markets, and Pulmonx is in second following its 122% increase. Outset Medical and Acutus are up 57% and 68%, respectively.

There is little that links the early winners of the medtech IPO class of 2020. Outset Medical sells a portable dialysis machine that is now cleared for home use, positioning the company to benefit from the anticipated shift away from in-center treatment that market leader Fresenius Medical Care talked about last week. Yet, Inari, Pulmonx and Acutus are all active in areas that have been negatively affected by the pandemic.

The presence of a pool of medtech companies that have found public investors receptive to their pitches has implications for the broader industry. Consultancy EY recently predicted a surge in M&A, in part due to the waning of IPOs as a viable way to raise money and provide an exit for private investors. If private medtech companies think they can go the IPO route, they may be less receptive to buyout bids from larger players.

Originally published by
Nick Paul Tayler | October 12, 2020
Medtech Dive

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NuVasive looks set to outperform analyst expectations in the second quarter, adding to evidence of a faster-than-predicted recovery in the medtech sector from COVID-19. In preliminary results shared Monday, spine technology company NuVasive estimated second quarter sales totaled between $202 million and $205 million, following analyst expectations of around $152 million.

The results are better than a mid-quarter update from NuVasive predicted, leading analysts at Needham to calculate that the company may have achieved double-digit growth in June.

Still, the pandemic has done damage. In addition to a 30% year-over-year sales drop, NuVasive reported $20 million to $25 million in charges related to the impact of the outbreak on its inventory and accounts receivable. The company expects the combination of falling sales and the charges to result in an operating loss of $35 million to $40 million.

As a spine surgery specialist, NuVasive is highly vulnerable to the deferral of elective procedures. A slowdown in spine surgeries began in March, causing NuVasive's sales to fall 5% in the first quarter and prompting the company to brace investors for further declines in the second and third quarters. At that time, NuVasive CFO Matt Harbaugh said it would be “dangerous” to extrapolate early signs of a recovery seen in April out to May and June.

Nonetheless, NuVasive shared an update early last month revealing that case volumes fell 70% in April but began to rebound in early May and accelerated throughout the rest of the month. The turnaround led the company to predict second quarter sales would fall less than 45%, provided performance in June was stable. 

On Monday, NuVasive shared preliminary quarterly results that suggest June may have been better than stable. Sales for the second quarter as a whole were down around 30%, based on the preliminary figures. 

In an analysis that takes in NuVasive’s comment about a 70% decline in April and targeted 45% drop for the quarter if June was stable, the Needham analysts calculate that sales actually increased 13% last month. If accurate, the analysts think the finding shows “the procedural backlog is now driving above-normal revenue growth.” However, SVB Leerink analysts calculate sales were down around 10% in June.

Regardless, the cadence of the recovery is in keeping with comments from other medtech companies including Johnson & Johnson and Philips that have shared second quarter results. There is also evidence that NuVasive could be slightly outperforming rivals; sales at J&J’s spine unit fell 36% in the second quarter, compared to a 30% decline at NuVasive.

The company will release a fuller look at how it performed in the second quarter, and potentially share an assessment of third quarter trends, when it posts its final results after market close on Aug. 4.

Based on what NuVasive said Monday, some analysts expect the company to report continued momentum. “For a management team that is known to be very careful in their language/word choice, we think the positive tenor of this commentary could suggest at least some of the improving momentum seen throughout 2Q may be carrying over into July,” analysts at SVB Leerink wrote in a note to investors following the pre-release Monday.

Originally published by
Nick Paul Taylor | July 21, 2020
Medtech Dive

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Toronto-based Perimeter Medical Imaging wants to make breast conservation surgeries more efficient by combining an optical coherence tomography device with an AI engine to reduce the number of repeat surgeries required.

The possibility of repeat surgeries to remove cancer from women diagnosed with breast cancer is a reality of breast conservation surgery. In the U.S. about 25 percent of women need additional surgery after a lumpectomy, which is done to preserve breast tissue after an initial breast cancer diagnosis.

This is because, following a lumpectomy after which the patient is sent home, a pathologist’s report days or weeks later may find cancer at the margins of the excised breast tissue. And that positive margin means the patient has to undergo another surgery to fully remove cancer or undergo a full mastectomy. All of which is emotionally taxing for patients.

“They trust their surgeon that they are going to remove it and it’s a very difficult phone call that the surgeon has to make to the patient to say ‘I missed some of the cancer, so you have to come back for a surgery.'” said Andrew Berekely, co-founder of Perimeter Medical Imagine a Toronto startup that is developing an AI-powered solution to the problem of repeat breast cancer surgery. “That’s not a phone call that surgeons like to make.”

Perimeter Medical went public in a reverse takeover of a public company this week and is expected to start trading on the TSX Venture Exchange in Canada on July 6. The company raised private capital of C$10 million (about $7.3 million) from investors including Roadmap Capital, shareholders of the public company it took over and high net worth people. Perimeter Medical has also received a $7.4 million grant from the Cancer Prevention and Research Institute of Texas, according to Berkeley. The company has its U.S. offices in Dallas.

The technology that Perimeter hopes to commercialize includes a medical device that can perform optical coherence tomography (OCT) on excised breast tissue and then feed that imaging data into its AI engine to determine whether the margin is positive – in other words, does the tissue in the margins contain cancer. That real-time information can help to determine whether the surgeon needs to take out more of the breast tissue thereby perhaps reducing the chance of another surgery down the road.

“The OCT is used to scan the back of your eye which is a 1 cm area. We have adapted the technology to scan very large complex surfaces like a removed tissue specimen in a very fast amount of time and give information back in the operating room where it is a time-sensitive situation …,” Berkeley said.

That fast turnaround will be powered by the AI engine.

“We have custom-built machine learning algorithms specifically for OCT that are specifically trained on breast tissue and this is years worth of working and selecting clinical data. What we do is that we image the tissue and then we take the post-operative pathology – what the pathologist looks at under the microscope — and we do what’s called a correlation,” he explained. “So we take the exact same area [that a pathologist finds] when they see tissue under the microscope, [and] we can go back to the same area in the images and we label in our images what disease looks like and we feed that into the ML algorithm and the more we do that the better it gets at identifying new diseases.”

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Originally published by
Arundhati Parmar | July 2, 2020
MedCity News

 

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Pixabay

Israeli research lab JSOF has discovered multiple cybersecurity vulnerabilities impacting hundreds of millions of Internet of Things (IoT) devices across a wide range of industries, including medtech. The risks from the security loopholes, dubbed Ripple20, are high and could allow hackers to take control of infusion pumps remotely and alter medication dosages, according to an example given by the lab.

The Department of Homeland Security's Cybersecurity and Infrastructure Security Agency issued an advisory last week saying it was aware of Ripple20 and warned that "a remote attacker can exploit some of these vulnerabilities to take control of an affected system." CISA's advisory listed medtechs Baxter, B. Braun, and medical imaging company Carestream as being "affected" by the security loopholes. Medtronic and Philips appeared as "not affected" on the list.  

While Carestream was not immediately available for comment, Baxter and B. Braun each shared written statements with MedTech Dive calling the vulnerabilities low risk and manageable

The Ripple20 vulnerabilities identified by JSOF were discovered in code offered by Ohio-based third party software company Treck, which serves a large number of IoT device manufacturers. The issues stem specifically from Treck's software library, which has been widely disseminated.

"Affected vendors range from one-person boutique shops to Fortune 500 multinational corporations, including HP, Schneider Electric, Intel, Rockwell Automation, Caterpillar, Baxter, as well as many other major international vendors suspected of being of vulnerable in medical, transportation, industrial control, enterprise, energy (oil/gas), telecom, retail and commerce, and other industries," according to JSOF, a cybersecurity firm that says it caters to big corporations.

Nick Yuran, CEO of cybersecurity consultancy Harbor Labs in Baltimore, says his firm is actively following the Ripple20 vulnerabilities and issued a rare security alert to all of its clients, including infusion pump customers, urging them to inspect their systems and confirm whether they employ the Treck stack.

"In the most severe cases, an attacker may perform remote code execution, which gives the attacker complete control of the device," Yuran said. "We are advising our clients to take Ripple20 very seriously."

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Originally published by
Greg Slabodkin | June 24, 2020
MedTech Dive

 

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Credit: Joseph Fuqua II/UC Creative + Brand

 

The University of Cincinnati won a national grant to develop reusable facemasks that are sterilized with heat

 

Engineers at the University of Cincinnati are using a National Science Foundation grant to develop a face mask that can be sterilized with heat for re-use.

 

“Currently, there is a significant shortage of personal protective equipment, particularly face masks, due to the COVID-19 pandemic in the United States. Statistics show that one COVID-19 patient consumes on average 17 face masks per day worn by medical personnel,” said the principal investigators of the study, Vesselin Shanov, professor of chemical engineering, and Soryong “Ryan” Chae, assistant professor of environmental engineering.

With face masks in high demand – and an expectation that the widespread need for masks will continue as the virus persists – Shanov and Chae saw an opportunity to make an impact.

Read more here

 

Originally posted by:
bioengineer.org
May 28th, 2020

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Credit: University of Miami Health System

 

University of Miami Health System researchers publish commentary in Lancet Psychiatry

 

The COVID-19 pandemic is stressful enough, but for children and adults with autism spectrum disorder (ASD) and their families, the crisis can be especially difficult.

Adrien A. Eshraghi, M.D., M.Sc., professor of Otolaryngology, Neurological Surgery and Biomedical Engineering, has dedicated much of his career to caring for individuals with various disabilities including individuals with autism, who are very dear to him.
 

Dr. Eshraghi and Miller School coauthors published a new correspondence titled COVID-19: overcoming the challenges faced by individuals with autism and their families in The Lancet Psychiatry*. In this commentary, the authors address specific challenges patients with autism and their families might encounter during the pandemic, as well as what healthcare providers should know and do to ensure optimal and safe care.

Chances are good that providers caring for COVID-19 patients in all settings, including the emergency room (ER) and inpatient settings, will encounter adults and children with autism.

“Autism spectrum disorder prevalence has increased significantly in the last 20 years. In 2004, the prevalence of autism was 1 in 166. Today the Centers for Disease Control (CDC) estimates that 1 in 54 children are on the autism spectrum”, according to Dr. Eshraghi, who also is the director of the University of Miami Hearing Research and Communication Disorders Laboratory and co-director of the University of Miami Ear Institute.

Read more here

 

 

Originally posted by:
bioengineer.org
May 21st, 2020

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Silver Level Contributor

A patient having blood drawn for a Covid-19 antibody test. Photo credit: Pier Marco Tacca, Getty Images.

 

Verily, Alphabet’s life sciences arm, is launching a new study to better understand the immune response to Covid-19 and gain more information on the accuracy of tests.

Alphabet’s life sciences arm, Verily, is launching a new study to better understand the immune response to Covid-19.  The study, called Baseline Antibody Research, will offer serology testing to people who have already received a Covid-19 nasal swab test through Verily.

In March, Google’s sister company began screening for potential Covid-19 cases and connecting people to tests. The project was initially limited to San Francisco, but has since been expanded to more locations in California and 12 additional states through a partnership with Rite Aid.

With this new study, Verily will focus on antibody testing. The information could be useful in gleaning important information about immunity and helping track whether previous tests were effective in detecting the virus. 

Read more here

 

 

Originally posted by:
Elise Reuter
Medcitynews.com
May 18th, 2020

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Credit: Phil Jones, Senior Photographer, Augusta University

 

A group of tiny RNA that should attack the virus causing COVID-19 when it tries to infect the body are diminished with age and chronic health problems, a decrease that likely helps explain why older individuals and those with preexisting medical conditions are vulnerable populations, investigators report.

MicroRNAs play a big role in our body in controlling gene expression, and also are a front line when viruses invade, latching onto and cutting the RNA, the genetic material of the virus, says Dr. Sadanand Fulzele, aging researcher in the Department of Medicine and Center for Healthy Aging at the Medical College of Georgia at Augusta University.

But with age and some chronic medical conditions, the attacking microRNA numbers dwindle, reducing our ability to respond to viruses, says Dr. Carlos M. Isales, co-director of the MCG Center for Healthy Aging and chief of the MCG Division of Endocrinology, Diabetes and Metabolism.

Read more here

 

 

Originally posted by:
bioengineer.org
May 13th, 2020

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A new report by Strata indicated that health systems are already beginning to see the effect of the boom in unemployment as a result of the Covid-19 pandemic. Nearly 15% of the surveyed hospitals’ patients in early May were uninsured or self-pay patients.

With the Covid-19 pandemic creating the worst unemployment levels since the Great Depression, states are preparing for a drop off in the number of people with health coverage. Hospitals are already beginning to see the effects as they treat more uninsured patients, according to a report by Strata Decision Technology.

Unemployment rates reached 14.7 percent in April, according to the latest available data from theBureau of Labor Statistics. Hospitals, meanwhile, have seen a steady uptick in the number of uninsured or self-pay patients in the last three months. 

Read more here

 

Originally posted by:
Elise Reuter
medcitynews.com
May 11th, 2020

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Silver Level Contributor

Credit: University of Michigan

 

Food insecurity disparities by age, health status, race, ethnicity & education seen in National Poll on Healthy Aging; pandemic may have worsened them.

Even before the coronavirus pandemic wreaked havoc with the nation’s food supply and economy, one in seven adults between the ages of 50 and 80 already had trouble getting enough food because of cost or other issues, a new poll finds.

The percentage who said they’d experienced food insecurity in the past year was even higher among those in their pre-Medicare years, and those who are African-American or Latino. Older adults with lower household incomes and lower levels of education were also more likely to say they had had trouble getting food.

Read more here

 

Originally posted by:
bioengineer.org
May 11th, 2020

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Silver Level Contributor

PhotoPharmics has raised $11 million and aims to raise another $10 million to help in the development and commercialization of its specialized light therapy device to treat Parkinson's Disease.

The Food and Drug Administration recently awarded a breakthrough device designation for a phototherapy device intended to help patients with Parkinson’s Disease.

The non-invasive device is made by American Fork, Utah-based PhotoPharmics and is meant to be used at home, explained Kent Savage, CEO of PhotoPharmics, in an email response. The company’s website and press release claims that this is the first specialized light therapy device to receive such a priority designation for the FDA reserved for novel devices trying to fulfill an unmet patient need.

Read more here

 

Originally posted by:
ARUNDHATI PARMAR
medcitynews.com
May 7th, 2020

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Silver Level Contributor

Real-time technologies provider BATM has announced that its Adaltis subsidiary has launched ELISA Serological Test Kits that diagnose if a patient has had COVID-19 by detecting antibodies against it present in their blood.

The Adaltis Serological Tests are fully CE certified and the Group has started shipping initial orders. It is now increasing production for larger quantities to fulfil further orders received from these customers.

The ELISA serological test detects the body’s immune response to the infection caused by the virus rather than detecting the virus itself – to help identify those who have been infected and developed antibodies that may protect them from future infection.

Adaltis’ ELISA Serological Tests for COVID-19 are designed to test for IgA and IgM as well as IgG antibodies. Adaltis’ tests can be conducted both on standard ELISA machines that are already in use in laboratories and hospitals, and on Adaltis’ Personal LAB and NEXgen machines, which are pre-calibrated for these tests.
 

Read more here

 

Originally posted by:
med-technews.com
May 6th, 2020

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Silver Level Contributor

Credit: University of Leeds

Scientists have identified a key process in the way bacteria protect themselves from attack – and it heralds a new strategy in the hunt for antibiotics.

The researchers from the University of Leeds have pieced together how bacteria build their outer, defensive wall – in essence, the cell’s armour plating.

The research has focused on the gram-negative bacteria Escherichia coli, but the process they have discovered is shared by many pathogenic gram-negative bacteria – so it could have importance for tackling other gram-negative pathogens, including the top three on the World Health Organisation’s list of priority pathogens.

The findings are published today (01/05) in the journal Nature Communications.

Read more here

 

Originally posted by:
bioengineer.org
May 1st, 2020

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Silver Level Contributor

Coronavirus: A catalyst for change?

The coronavirus crisis demands a coming together to reach goals for the common good. This requires a fundamentally new way of working, one that, in our opinion, holds the key to solving healthcare's broader issues.

Coronavirus dominates every conversation as the world grapples with the magnitude of the Covid-19 pandemic. But policymakers and healthcare actors dare not simply wish for warmer weather or hope to “ride this one out.” Amidst the confusion and chaos lies an unparalleled opportunity to tap into the immense momentum generated by this crisis and usher in transformational changes to the healthcare sector that are long overdue. 

The coronavirus crisis exposes the limits of our current healthcare systems in dramatic fashion. For instance, in the U.S., an early response was slowed by issues ranging from approvals for diagnostic testing in hospitals rather than at the CDC, to contamination of testing kits at the CDC and patient eligibility for screenings. As director of the National Institute for Allergy and Infectious Disease, Tony Fauci, previously put it nearly a month ago “the system is not really geared to what we need right now, what you’re asking for [rapid deployment of testing]. That is a failing.” Unfortunately, the legacy of these early missteps may be what slows the country down from reopening, as testing availability is critical for plans to ease social distancing measures.

Read more here

 

Originally posted by:
BEN ALSDURF AND THOMAS HAGEMEIJER
medcitynews.com
April 29th, 2020

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JAAGNet MedTech Trends

LSI 2021 EMERGING MEDTECH SUMMIT

BIOMEDevice - Boston 2021

  • Description:

    BIOMEDevice - Boston 2021
    https://biomedboston.com/

    Rescheduled to September 2021

    2,200+ industry professionals and 335+ suppliers convene in Boston — home to the nation's highest number of medical device companies — for a two-day event focused on moving medtech design projects to the next stage of development.

    BIOMEDevice lets you explore the trends driving advancements in healthcare as well as discover…

  • Created by: Kathy Jones
  • Tags: biomedevice, boston, north america, medtech

MED-TECH INNOVATION SUMMIT

  • Description:

    MED-TECH INNOVATION SUMMIT
    https://med-techexpo.com/event/en/page/home

    New dates announced – September 28-29, 2021

    Med-Tech Innovation Expo is the UK & Ireland’s leading event for medical design and manufacturing technology.

    Experience live demonstrations of the latest machine, technology, products and services while networking with 4,000 + designers, engineers, innovators and…

  • Created by: Kathy Jones
  • Tags: med-tech, summit, june 2021, nec, birmingham, uk

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