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coronavirus (16)

Gold Level Contributor

Cellex's app will help automatically report results to public health authorities to aid in contact tracing while giving users who have tested negative a mobile pass showing the result. (Shutterstock)

Diagnostic maker Cellex has announced plans to develop a rapid coronavirus infection test that people can fully perform at home, from sample collection to result—with 15-minute readings double-checked by a personal smartphone app.

The company is partnering up with Gauss, a developer of machine vision-based healthcare programs, to help digitize the results of its upcoming COVID-19 antigen test.

Cellex said it is currently working to validate its diagnostic, which has previously shown a false negative rate of about 10% while returning no false positive results, through clinical trials.

Meanwhile, the smartphone app from Gauss aims to provide step-by-step video instructions on how to self-collect a nasal swab sample and perform the test. After 15 minutes, the app prompts the user to scan the result using the smartphone’s camera, which reads the image and confirms whether it is positive or negative. 

“This AI-enabled COVID-19 antigen test for home use will make self-monitoring and isolation feasible, thereby playing a significant role in changing the trajectory of the COVID-19 pandemic in America and beyond,” said James Li, founder and CEO of Cellex, which previously received the FDA’s first emergency authorization for a rapid COVID-19 antibody blood test in April.

The app will also help automatically report results to public health authorities to aid in contact tracing while giving users who have tested negative a mobile pass showing the result. Outside of the home, when used by healthcare professionals, the app can send results to a patient’s electronic health record.

“By embedding advanced computer vision algorithms within a thoughtfully-designed user experience, we can enable consumers to perform a rapid test in their own homes just as well as a trained operator or a laboratory instrument—simply by using their smartphone cameras,” Gauss founder and CEO Siddarth Satish said.

Cellex and Gauss said they aim to have the antigen test and companion app authorized by the FDA this fall.

Originally published by
Conor Hale | September 17, 2020
Fierce Biotech

Read more…
Gold Level Contributor

Courtesy of Roche

Roche's COVID-19 and influenza A/B test for use on the Swiss company's benchtop Cobas Liat system has received an emergency use authorization from the FDA. 

The rapid diagnostic, which gives results for single samples within 20 minutes, is the second EUA for the Roche combination test. The company's Cobas SARS-CoV-2 & Influenza A/B test, designed to run on its 6800/8800 systems and provide 96 results in about three hours, got FDA's nod earlier this month.

With the approaching flu season, the latest EUA for the Roche test gives the new option of conducting rapid testing in either point-of-care or clinical laboratory settings to detect and differentiate between the viruses. It is the FDA's fifth emergency authorization for such a combination diagnostic.

Dive Insight:

FDA in July granted emergency authorization to a test developed by the Centers for Disease Control and Prevention to determine if a patient is infected with the flu or the novel coronavirus. The agency previously authorized similar combination tests from BioFire Diagnostics and Qiagen in the spring. However, the two EUAs Roche has received in as many weeks are the first for such a major testing manufacturer.  

The latest EUA provides Roche with an authorized rapid diagnostic to help healthcare providers distinguish between the contagious respiratory illnesses caused by different viruses.

The test is to be used with provider-collected nasopharyngeal and nasal swabs and self-collected nasal swabs, collected in a healthcare setting with instruction by a provider, from individuals suspected of respiratory viral infection consistent with COVID-19, according to FDA.

The ability of Roche's system to provide results for single samples within 20 minutes in POC and clinical lab settings is a much faster combo test than the one authorized earlier this month. At the time, Roche claimed the EUA to be the first for a commercial diagnostic that runs on fully automated high-throughput systems and can discern between the three viruses in a single sample.

Originally published by
Greg Slabodkin | September 16, 2020
MedtechDive

Read more…
Silver Level Contributor

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

Read more…
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

Read more…
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

Read more…
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

Read more…
Silver Level Contributor

University Hospitals Birmingham NHS Foundation Trust (UHB) and AI specialist Skin Analytics are to pilot a new skin cancer community assessment service to reduce delays in skin cancer detection and treatment during the Coronavirus pandemic.

There are around 8-13 million GP appointments booked for skin cancer assessments every year across the UK. Around 16,200 people are diagnosed with melanoma, which is now the fifth most common cancer in Britain. While 2,300 people die each year, the survival rates improve significantly if the disease is caught early. By introducing a tele-dermatology service, UHB referred patients will have potentially cancerous skin lesions assessed and receive life-saving treatment sooner.

During the pilot, referred patients will be provided with skin cancer triage outside of the hospital setting, using AI technology to capture high quality images of those lesions which may be melanoma and requiring priority investigation by a dermatologist, and those that are safe to defer according to the BAD guidelines. The service will help flatten the demand curve to manage the ongoing clinical risk when social isolation measures are lifted, and the latent demand is released.

Read more here

 

 

Originally posted by:
www.med-technews.com
April 29th, 2020

Read more…
Silver Level Contributor

Credit: Dyson

 

The UK government had originally ordered 10,000 CoVent ventilators and the company said it had worked with outside experts from the MHRA and the NHS throughout the design process to allow for quick regulatory clearance in order to increase ventilator capacity in order to tackle to the Coronavirus.

The Dyson CEO and founder said he would hope the ventilators found use in other countries and that the £20 million spent on the project would be funded by himself – meaning he won’t be accepting money from the public purse.

 

Read more here

 

Originally posted by:
med-technews.com
April 27th, 2020

Read more…
Silver Level Contributor

An IoT Button that was originally intended for parents to locate their children in the event they were lost or in danger has seen a spike in interest following the Coronavirus outbreak.

In the last eight weeks Secufy has seen enquiries from health organisations across the world looking for solutions to plug critical care communication challenges.

Demand for Secufy’s IoT Button to solve critical use cases within health organisations has meant scaling production 100x in a very short time frame. 

The Secufy Button is being deployed in healthcare scenarios including:

  • Patients who are sent home with weak symptoms after having tested positive for COVID-19 are given a Secufy IoT Button. Should the patient's condition worsen, they press the button which alerts clinicians through a pre-defined comms channel. This circumnavigates normal telephone helplines.
  • The Secufy Button is deployed providing an instant secondary comms infrastructure for nurse call systems within hospitals.
  • The elderly and vulnerable who are self-isolating receive a Secufy Button that cascades an alert to family members in the event of an emergency. 
  • The Secufy Button can also be used to act as a tracker to ensure quarantine is being adhered to or to notify family members if an elderly relative has been out (and not returned).

Read more here

 

Originally posted by:
med-technews.com
April 24th, 2020

Read more…
Silver Level Contributor

Innovative medical technologies are set to play a key role in the nation’s COVID-19 response. Dr Kit Latham, CEO of London-based medical HR specialists Credentially, explains why.

 

COVID-19 is the greatest public health challenge the UK has faced in a generation. In order to tackle the pandemic head-on, it’s vital that we mobilise an expanded force of healthcare workers and volunteers as quickly as possible. It has been heartening to see so many people step up to the plate over the last few weeks, but there are still major challenges to overcome in this respect – obstacles that can only be surmounted by harnessing the power of technology.

Unfortunately, the way we traditionally hire healthcare workers could act as a major stumbling block to adequately combatting the virus. The NHS’s hiring process usually takes between three and six months, and for every 10 clinicians that apply for a job in healthcare – not just within the NHS – only five will ever work a shift. Sadly, up to 50% become frustrated and give up on the process.

In the current circumstances, it’s more important than ever to train, on-board and validate staff as swiftly and safely as is practicably possible. These are the hurdles we sought to overcome when we established Credentially. Our signature software makes clinical HR and compliance processes quicker and easier for healthcare workers and their employers, so they can get to the frontline of the COVID-19 response ASAP. The software also reduces the manual work involved in getting a health worker on the shop floor by up to 90%, and – most helpfully in this age of social distancing – it eliminates the need for face-to-face interaction.

Read more here

 

Originally posted by:
Kit Latham
med-technews.com
April 24th, 2020

 

 

 

Read more…
Silver Level Contributor

Global cloud communications software and solutions provider IMImobile, has announced its healthcare division, Healthcare Communications, has launched its eClinic software to NHS Trusts for free for a year.

 

The video consultation software allows for patients to see their clinicians via online consultations, from their own homes. This means that regular health checks and medical reporting can continue even if patients or healthcare professionals are self-isolating.

Kenny Bloxham, managing director at Healthcare Communications, said: “We all need to support the NHS through this crisis; by switching as many appointments to virtual as possible, we can ensure services are not overwhelmed in the future. The eClinic solution is clinician led, so patients don’t spend lengthy periods in ‘virtual’ waiting rooms – instead, clinicians can immediately connect with their patient. It can be rolled out at scale across hospitals and GPs within days, and looking to the longer term, represents a sustainable way to redesign the patient pathway for the future.”

 

Read more here

 

Originally posted by:
www.med-technews.com
April 22nd, 2020

Read more…
Silver Level Contributor

The Danish Government is launching two new digital solutions to drive the safe and controlled reopening of Denmark, after the government mandated lockdown due to COVID-19.

IT services provider, Netcompany, has developed the broad national emergency applications for use by both the Danish health authorities and citizens, to support Coronavirus efforts, and will be available to the country’s public within two weeks. 

 

COVIDmeter – monitoring the prevalence of COVID-19

COVIDmeter will collect information from citizens about disease symptoms in relation to COVID-19. The new digital solution can be used by all Danish citizens. Login is via a system usually used for online banking. The system can also inform users of up to date information on COVID-19 from the public authorities.

Users will be encouraged to fill out a digital questionnaire about their health on a weekly basis, allowing authorities to assess the development of the epidemic. Symptoms, recovering status after COVID19, and many other data is collected.

The Danish Serum Institute will use the data to monitor the spread of infection in the community. Danish citizens can now sign up for the new COVIDmeter solution at sundhed.dk.

 

Read more here

 

 

Originally posted by:
www.med-technews.com
April 22nd, 2020

Read more…
Silver Level Contributor

LIVI is launching UK national guidelines to NHS GPs, to provide training and treatment on how they can spot and manage COVID-19 symptoms in their patients over phone or video.

These directions, which were produced in the absence of national guidelines for COVID-19 and digital healthcare in the UK, have been produced by LIVI’s clinical team of NHS Doctors and in partnership with the NHS.

They will help to ensure that all doctors in the UK can spot early signs of COVID-19 and help them to better understand the pandemic and how it develops.

 

Read more here

 

Originally posted by:
www.med-technews.com
April 21st, 2020

Read more…
Silver Level Contributor

The Oxford Foundry (OXFO), an entrepreneurship centre at the University of Oxford, has launched a two-part action plan to accelerate solutions to problems caused by the COVID-19 pandemic. 

 

The Foundry team has convened a global taskforce of more than 60 entrepreneurs, policy-makers, investors, business leaders, and philanthropists. These include Foundry board members, advisors and supporters:

  • Mohamed Amersi, founder of the Amersi Foundation
  • Biz Stone, co-founder of Twitter
  • Reid Hoffman CBE, internet entrepreneur and venture capitalist
  • Alexsis de Raadt St James, founder and managing partner of Merian Ventures, board member of the Fulbright US-UK Foundation
  • Honorary advisor Arlan Hamilton, founder of Backstage Capital
  • Angela Ahrendts DBE, former CEO of Burberry and SVP retail at Apple
  • Arunma Oteh, former vice president and treasurer at the World Bank

 

Read more here

 

Originally posted by:
med-technews.com

April 20th, 2020

 

Read more…
Silver Level Contributor

The Union Health Ministry has issued an advisory against spraying of disinfectant on people for Covid-19 management, saying it was physically and psychologically harmful.

 

The Union Health Ministry has issued an advisory against spraying of disinfectant on people for Covid-19 management, saying it was physically and psychologically harmful. Even if a person is potentially exposed to the Covid-19 virus, spraying the external part of the body does not kill the virus that has entered the body, it said, adding there is no scientific evidence to suggest that they are effective even in disinfecting the outer clothing/body in an effective manner.
The ministry said it has received many queries regarding the efficacy (if any) of use of disinfectants such as sodium hypochlorite spray on individuals to disinfect them. "The strategy seems to have gained of lot of media attention and is also being reportedly used at local levels in certain districts/local bodies," the ministry said.
 

Read more here

 

Originally posted by:
economictimes.indiatimes.com
April 19th, 2020

 

Read more…
Silver Level Contributor

Limited compassionate use data for the drug remdesivir and a media report about leaked results from the Phase III studies have generated excitement, but many have urged caution in interpreting such early data - especially without comparators.

 

Data from Gilead Sciences’ two Phase III trials of the investigational Covid-19 drug remdesivir are anticipated to come out this month or next. Some early results have already trickled into the public domain, providing snapshots that, while limited, have nevertheless sent the company’s shares soaring. But medical experts and other observers have urged caution.

On April 10, the Foster City, California-based company announced data on 53 patients with severe disease who had received the drug under compassionate use protocols, with many seeming to benefit from it. And on Thursday, even more explosive news emerged as STAT reported on a video recording that had been leaked in which an investigator from a site that had enrolled 125 patients in the Phase III trials discussed anecdotal results indicating that the drug appeared effective, and mostly in patients with severe disease.

 

Read more here

 

Originally posted by:
ALARIC DEARMENT
www.medcitynews.com
April 19th, 2020

 

Read more…

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  • Description:

    BIOMEDevice - Boston 2021
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