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Hologic granted second molecular COVID-19 test EUA

Hologic (NSDQ:HOLX) announced today that it received FDA emergency use authorization (EUA) for its Aptima SARS-CoV-2 assay for detecting COVID-19.

Marlborough, Mass.-based Hologic’s Aptima test runs on its fully automated Panther system that provides initial results in approximately three hours, processing more than 1,000 coronavirus tests in 24 hours.

Hologic said in a news release that it began distributing the new test and expects to produce an average of one million tests per week by combining its manufacturing capacity with what it touts as the world’s largest installed base of high-throughput molecular instruments.

Aspects of the Aptima assay project were conducted under a $13 million contract from the U.S. Dept. of Health and Human Services through the Biomedical Advanced Research and Development Authority (BARDA).

Hologic intends to register the Aptima SARS-CoV-2 assay for CE Mark approval in Europe later this month, according …

What medtech’s top CEOs are saying about COVID-19

The COVID-19 pandemic is drying up sales for many large medical device companies, but there’s hope for a recovery later this year.

That’s the big message from medtech’s top CEOs as they issue financial predictions and engage in earnings calls with analysts.

Governments around the world are calling on medical device companies to make the supplies that health providers need to manage the virus: respirator masks, ventilators, infusion pumps, virus and antibody tests, and more.

At the same time, the same companies are taking a hit related to the devices and products used in elective procedures — and even procedures that people actually need — as hospitals focus on saving people with COVID-19.

It’s little wonder then that MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — remains down about 10% from its pre-pandemic Feb. 19 high point. (It’s still in better shape than the Dow Jones Industrial Averag…

Study: PPE shortages persist nationwide

(Image from GetUsPPE)

Shortages of personal protective equipment continue to plague hospitals and healthcare facilities across the United States, according to a study published this week in The Lancet.

The study reports on data collected by GetUsPPE, a volunteer organization connecting healthcare providers with supplies of PPE during the COVID-19 pandemic and was authored by academics and volunteers from Harvard Medical School, Massachusetts General Hospital, Alpert Medical School at Brown University, Google and Pymetrics.

Most of the 6,169 hospitals, healthcare and other facilities — including nursing homes — that made PPE requests through GetUsPPE asked for N95 respirators (74%), surgical masks (64%), gowns (61%), and face shields (60%), according to the study. High COVID-19 infection and death rates have been reported at nursing homes across the country.

Metropolitan areas comprised 5,416 (8…

Study: PPE shortages persist nationwide

(Image from GetUsPPE)

Shortages of personal protective equipment continue to plague hospitals and healthcare facilities across the United States, according to a study published this week in The Lancet.

The study reports on data collected by GetUsPPE, a volunteer organization connecting healthcare providers with supplies of PPE during the COVID-19 pandemic and was authored by academics and volunteers from Harvard Medical School, Massachusetts General Hospital, Alpert Medical School at Brown University, Google and Pymetrics.

Most of the 6,169 hospitals, healthcare and other facilities — including nursing homes — that made PPE requests through GetUsPPE asked for N95 respirators (74%), surgical masks (64%), gowns (61%), and face shields (60%), according to the study. High COVID-19 infection and death rates have been reported at nursing homes across the country.

Metropolitan areas comprised 5,416 (8…

RespiraWorks, ICS partner on inexpensive ventilator for developing countries

RespiraWorks. and Integrated Computer Solutions (ICS) announced a partnership to collaborate on the former’s open-source ventilator.

San Francisco-based Respiraworks touts the medical-grade device as capable of being assembled for less than $500. The company designed the system for long-term vs. crisis use and for developing countries with the intent to source and manufacture locally, according to a news release.

A volunteer group of mechanical, process, electrical and controls engineers formed RespiraWorks last month to combine their knowledge of life support and critical engineering applications amid the COVID-19 pandemic.

“While most teams are addressing the need for “bridge” type ventilators to keep someone alive for six to eight hours, we are not aware of any tackling the ventilators for longer-term needs in an open-source, supply chain-optimized manner, and that’s where this team provides value,” RespiraWorks founder Ethan Chaleff said in the…

HHS announces $5 million award for COVID-19 research

The U.S. Health and Human Services Dept. announced today that it will offer a $5 million award this year to support research related to COVID-19.

The new funding opportunity announcement (FOA) is set to support novel, high-impact studies evaluating the responsiveness of healthcare delivery systems, healthcare professionals and the overall U.S. healthcare system amid the COVID-19 pandemic.

HHS announced the FOA through the Agency for Healthcare Research & Quality (AHRQ), which expects to invest the $5 million for new multi-method, rapid-cycle research with the ability to produce and disseminate initial observations within six months following the award, then regularly throughout the remainder of the award period.

AHRQ noted that the funding will support critical research focused on quality, safety and value of the health system’s response to COVID-19, the role of primary care practices and professionals during this pandemic, understanding how th…

Pfizer to outsource more production as it prepares for COVID-19 vaccine

Pfizer is turning to its 200-strong network of outside contractors to make more of its existing medicines as it prepares for a potential COVID-19 vaccine., according to media reports.

The New York–based pharmaceutical giant said May 5 that it will invest at-risk to produce millions of doses of a coronavirus vaccine in 2020, boosting production to hundreds of millions of doses in 2021. Pfizer sites in Massachusetts, Michigan, Missouri and Puurs, Belgium will serve as vaccine manufacturing centers — with more sites expected to be added to the list.

BioNTech — Pfizers’s partner in developing a COVID-19 vaccine — plans to ramp up production sites in Mainz and Idar-Oberstein, Germany,

The first participants in Pfizer and BioNTech’s Phase 1/2 clinical trial for the BNT162 vaccine program have already been dosed in Germany and the U.S.

“The short, less than four-month timeframe in which we’ve been able to move from pre-clinical studies …

Could AI predict COVID-19 without testing?

Researchers in England and Massachusetts have developed an artificial intelligence diagnostic that can predict the likelihood of someone having COVID-19 based on symptoms.

King’s College London, Massachusetts General Hospital and health science company Zoe have developed an AI model that uses data from the COVID Symptom Study app to help predict COVID-19 infection. It compares symptoms and the results of traditional COVID tests to help populations that have limited access to testing.

According to the researchers, more than 3.3 million people around the world have downloaded the app and are reporting daily health status.

The researchers have analyzed data from 2.5 million people in the U.S. and the U.K who have regularly been logging their health in the app. About one-third of the people logged COVID-19 related symptoms. Of the one-third, 18,374 have had a coronavirus test and 7,178 tested positive.

Symptoms associated with COVID-19 were anal…

PTI Engineered Plastics donating thousands of face shields against COVID-19

PTI Engineered Plastics has a goal of manufacturing 100,000 face shields. [Image courtesy of PTI Engineered Plastics]

PTI Engineered Plastics has collaborated with industrial designers at PTI Design to create a protective face shield that can be quickly produced using injection molding manufacturing — helping to boost the supply of protective equipment for health providers treating people with COVID-19.

The Macomb, Mich.–based company says production of the shields started last week, with a goal of manufacturing 100,000 pieces in total.

PTI Engineered Plastics is coordinating donations with hospitals, skilled nursing facilities, hospice care and dental offices. Once more critical requests are met, donations could go to first responders and law enforcement personnel, followed by grocery stores and other essential workers.

PTI turned to existing designs or reference — but also made improvements:

…

India-led research effort asks the question: How do we keep a potential COVID-19 vaccine cold?

[Image courtesy of University of Birmingham]

U.K. scientists have joined a research effort in India to help solve distribution problems around whatever COVID-19 vaccine hopefully emerges from global efforts, according to a recent news release from the University of Birmingham.

Backed by the Shakti Sustainable Energy Foundation, experts from the University of Birmingham and Heriot-Watt University, Edinburgh are investigating the challenge involved in distributing a potentially temperature-sensitive COVID–19 vaccine.

The Centre for Environment Education (CEE) in India is leading the overall research, with support from commercial partners such as Zanotti (a part of the Daikin Group), Sure Chill and Nexleaf Analytics. The British researchers are exploring how integrated “Community Cooling Hubs’” can integrate food cold chains with other cold-dependent services such as community health fac…

DeviceTalks Weekly: Ep. 9 – What’s the state of the medtech job market?

In this week’s episode of DeviceTalks Weekly, Tom Salemi speaks with two executive recruiters about what they see in the medtech market. Over the past month, we’ve seen several medtech companies – big and small – cutting jobs and reducing hours but what does this mean long-term.

In this podcast we’ll identify a few companies that are hiring, but we’ll talk in-depth with the recruiters about…

How bad is the current market? What’s the likelihood for recovery? What skills are in greater demand? What can people do to strengthen their hand?

Guests are:

David L. Vied, global sector leader, Global Sector Leader, Medical Devices and Diagnostics, Korn Ferry Giovanni Lauricella, VP, medtech practice-lead, The Mullings Group

Don’t miss an episode! Subscribe to DeviceTalks Weekly on your podcast players.