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MedTech 100 roundup: Another rebound as markets continue to fluctuate

Medtech stocks rebounded from a significant dip earlier in June last week, continuing to highlight the topsy-turvy nature of the markets during the COVID-19 pandemic.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 85.00 points at the end of last week (June 19). That total represents a 3.5% increase from the 82.12-point total at the same time a week prior (June 12), demonstrating another uptick after a -6% drop-off just one week before.

Meanwhile, the S&P 500 Index experienced a 1.9% increase from June 12 to June 19, and the Dow Jones Index fared slightly worse with a 1% increase over the same period of time. Both indexes mirrored medtech’s rebound, having posted -4.8% and -5.6% decreases, respectively, the week before.

Medtech’s lowest point during the COVID-19 pandemic remains at 62.13 on March 23. Since then, the industry’s stocks have experienced 36.8% growth in total. Stocks i…

FDA warns against using certain COVID-19 tests

The FDA issued a statement recommending that clinical laboratories and healthcare providers stop using COVID-19 antibody tests on its “removed” list.

Found under the FDA’s FAQs on Testing for SARS-CoV-2 page, the removed list includes tests for which significant clinical performance problems were identified and cannot or have not been addressed by the manufacturer in a timely manner. Also included are tests for which an emergency use authorization (EUA) request was not submitted within a reasonable period of time and tests voluntarily withdrawn by the manufacturers.

Although tests on the “removed” list shouldn’t be distributed, laboratories and providers may still have the tests within their stock and may have used the tests in the past, according to the FDA statement.

The FDA recommends that laboratories and healthcare providers cease use of the tests on the “removed” list and evaluate whether prior test r…

Assisted living survey shows ongoing struggle for supplies during COVID-19 pandemic

A survey of National Center for Assisted Living members revealed that a number of people are still facing equipment shortages during the COVID-19 pandemic.

Assisted living facilities have been hit particularly hard by the virus, with a recent report from the Associated Press citing government data confirming that nursing home residents account for nearly 1 in 10 of all the coronavirus cases in the United States and more than a quarter of the deaths.

Get the full story at our sister site, MassDevice.

Assisted living survey shows ongoing struggle for supplies during COVID-19 pandemic

A survey of National Center for Assisted Living members revealed that a number of people are still facing equipment shortages during the COVID-19 pandemic.

Assisted living facilities have been hit particularly hard by the virus, with a recent report from the Associated Press citing government data confirming that nursing home residents account for nearly 1 in 10 of all the coronavirus cases in the United States and more than a quarter of the deaths.

Between June 10 and June 17, 375 NCAL members shared information regarding their supply of personal protective equipment (PPE) during the pandemic.

Among those members, 53% reported a less than two-week supply of N95 respirator masks and 36% cited a shortage of surgical masks over the same stretch. For the same two-week timeframe, the survey recorded 34% of respondents noting a shortage of face shields, 52% coming up short on gowns and 31% with a less than two-week supply of gloves.

Seven out of 10 ass…

Merck acquires Themis to speed COVID-19 vaccine development

Merck (NYSE:MRK) announced today that it completed the acquisition of vaccine and immune-modulation therapy developer Themis for an undisclosed amount.

In connection with the acquisition, the U.S. Federal Trade Commission granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, while Merck gained merger control from the Austrian Federal Competition Authority, making Themis now a wholly-owned subsidiary of Merck.

Get the full story at our sister site, Drug Discovery & Development.

Merck acquires Themis to speed COVID-19 vaccine development

Merck (NYSE:MRK) announced today that it completed the acquisition of vaccine and immune-modulation therapy developer Themis for an undisclosed amount.

In connection with the acquisition, the U.S. Federal Trade Commission granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, while Merck gained merger control from the Austrian Federal Competition Authority, making Themis now a wholly-owned subsidiary of Merck.

Merck and Themis are set to accelerate and develop a measles vector-based SARS-CoV-2 vaccine as an early focus of the acquisition. The candidate is currently in pre-clinical development with clinical studies planned to begin later this year, according to a news release.

Last month, Merck announced today that they are collaborating with IAVI to develop an investigational vaccine against SARS-CoV-2 for preventing COVID-19.

Just days after that announcement, Merck announced that i…

FDA expands public-private effort on COVID-19 research

The FDA announced that it is participating in the COVID-19 Diagnostics Evidence Accelerator project to advance the development of diagnostics.

Organized by the Reagan-Udall Foundation for the FDA and in collaboration with Friends of Cancer Research, the multi-stakeholder project is the companion to the previously announced Therapeutic Evidence Accelerator for sharing insights, comparing results and answering key questions to inform the collective COVID-19 response.

Strategies involved in the latest collaboration include evaluating real-world performances of SARS-CoV-2 diagnostic and antibody tests to determine if the presence of antibodies can indicate future immunity and, if so, which specific antibodies and epitopes contribute to protection against future infection.

Other uses of real-world data can provide information about the prevalence of SARS-CoV-2 in specific populations and highlight individual risk factors, according to an FDA news release. Evi…

3M settles N95 price-gouging suit

3M (NYSE:MMM) has reached a settlement ending one of its lawsuits against companies selling marked-up N95 respirator masks amid the COVID-19 pandemic.

In the filing, dated June 18, 3M moved to dismiss its case against TAC2 Global, a Clearwater, Fla.-based company that “specializes in an extensive selection of specialized tactical gear, ballistic protection and apparel,” according to its website.

In federal court in Tampa, Fla., 3M originally sued TAC2 Global LLC for allegedly trying to sell the Florida Department of Management Services State Emergency Operations Center 5 million to 10 million N95 respirators and hand sanitizer at highly inflated prices. TAC2 falsely claimed to be a 3M supplier, according to 3M.

The companies reached a settlement, for which details were not released, and filed a notice to cancel a preliminary injunction hearing scheduled for today.

TAC2 Global was one of five companies that 3M announced it was suing for…

GE Healthcare launches chest X-ray AI to better spot COVID-19

Officials at GE Healthcare (NYSE:GE) think the company’s new Thoracic Care Suite — a collection of eight AI algorithms from Lunit Insight CXR — could help clinicians in the fight against COVID-19.

The AI suite, launched today, quickly analyzes chest X-ray findings and flags abnormalities for radiologist review, according to GE. It can spot potential pneumonia — a symptom of COVID-19. It can also highlight tuberculosis, lung nodules, and other radiological findings.

Get the full story on our sister site Medical Design & Outsourcing.

GE Healthcare launches chest X-ray AI to better spot COVID-19

Officials at GE Healthcare (NYSE:GE) think the company’s new Thoracic Care Suite — a collection of eight AI algorithms from Lunit Insight CXR — could help clinicians in the fight against COVID-19.

The AI suite, launched today, quickly analyzes chest X-ray findings and flags abnormalities for radiologist review, according to GE. It can spot potential pneumonia — a symptom of COVID-19. It can also highlight tuberculosis, lung nodules, and other radiological findings.

“The launch of our Thoracic Care Suite is a part of GE Healthcare’s larger effort to help ensure clinicians and partners on the front lines have the equipment they need to quickly diagnose and effectively treat COVID-19 patients,” GE Healthcare CEO Kieran Murphy said in a news release.

“The pandemic has proven that data, analytics, AI and connectivity will only become more central to delivering care. For GE Healthcare, that means continuing to advance intelligent health and providing inn…

HHS spending $347m to boost supply of COVID-19 vaccine, treatment vials

The U.S. Dept. of Health & Human Services (HHS) and Dept. of Defense (DoD) announced a joint effort to increase manufacturing for vials earmarked for COVID-19-related drugs and vaccines.

The Biomedical Advanced Research and Development Authority (BARDA), as part of HHS, collaborated with DoD to provide funding for U.S.-based companies Corning Inc. and SiO2 Materials Science.

Get the full story at our sister site, Pharmaceutical Processing World.

HHS spending $347m to boost supply of COVID-19 vaccine, treatment vials

The U.S. Dept. of Health & Human Services (HHS) and Dept. of Defense (DoD) announced a joint effort to increase manufacturing for vials earmarked for COVID-19-related drugs and vaccines.

The Biomedical Advanced Research and Development Authority (BARDA), as part of HHS, collaborated with DoD to provide funding for U.S.-based companies Corning Inc. and SiO2 Materials Science.

Get the full story at our sister site, Pharmaceutical Processing World.