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DeviceTalks Weekly

In Episode 10 of DeviceTalks Weekly, we talk with two successful starters of medtech companies about how they’re building and maintaining their medtech portfolios during this pandemic landscape.

Our guests this week are Dr. Justin Klein, managing partner of Vensana Capital, and Duke Rohlen, chair of Ajax Health. Together, Klein and Rohlen have created, backed and sold medtech companies that have generated billions.

Klein, formerly of New Enterprise Associates, now co-manages his own venture firm, Vensana Capital. He previously served on the board of directors of Cartiva (acquired), ChromaCode, CV Ingenuity (acquired), EPIX Therapeutics (acquired), FIRE1, GPB Scientific, Intact Vascular, Metavention, Personal Genome Diagnostics, PhaseBio Pharmaceuticals (IPO), Relievant Medsystems, Senseonics (IPO), Topera (acquired), Ulthera (acquired), Vertiflex (acquired), Vesper Medical and Vytro…

Could face masks light up to detect COVID-19?

Researchers at Harvard University have developed a face mask with a sensor to detect COVID-19, according to a BusinessInsider report.

Wyss Institute researcher James Collins and his group developed a rapid self-activating COVID-19 diagnostic face mask. It can be worn by patients or people at home who have symptoms of coronavirus to quickly signal the presence of the virus without the need for hands-on manipulation, according to Harvard University.

Collins and the researchers suggest that patients can be easily triaged for proper medical care while healthcare workers and patients nearby are protected by using the diagnostic wearable.

The mask is made using highly sensitive molecular sensors coupled to synthetic biology networks and shows an immediately visible or florescent color signal when CoV2 is detected. It is cell-free molecular machinery that is freeze-dried and integrated with synthetic material on the interior of the face mask.

Once expose…

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…

FDA warns on accuracy of Abbott rapid COVID-19 test

Abbott’s ID Now test machine (Image from Abbott)

After weeks of concerns about the accuracy of an Abbott (NYSE:ABT) rapid COVID-19 diagnostic test, the FDA last night issued a warning that the ID NOW test may return false-negative results.

Citing “early data,” the agency said it is “sharing early information … about potential inaccurate results in the spirit of transparency.”

A preliminary study released this week by researchers at New York University found that the test missed up to 48% of positive results. Researchers at the Cleveland Clinic reported in April that the ID NOW had a false-negative rate of 14.8%, according to a report by National Public Radio.

One issue is the treatment of specimens before they are placed in the ID NOW machine. Abbott advised customers on April 15 that placing specimens in liquid viral transport media before processing — stan…

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…

Gilead licenses remdesivir production to 5 generic drugmakers

Gilead Sciences’ (NSDQ:GILD) said Tuesday that it has signed licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir, the experimental drug being used in the U.S. to treat COVID-19.

The non-exclusive, voluntary agreements allow the companies — Mylan (NSDQ:MYL), Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences — to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access, according to Foster City, Calif.-based Gilead.

Get the full story on our sister site, MassDevice.

Gilead licenses remdesivir production to 5 generic drugmakers

(Image from Gilead Sciences)

Gilead Sciences’ (NSDQ:GILD) said Tuesday that it has signed licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir, the experimental drug being used in the U.S. to treat COVID-19.

The non-exclusive, voluntary agreements allow the companies — Mylan (NSDQ:MYL), Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences — to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access, according to Foster City, Calif.-based Gilead.

The FDA gave remdesivir emergency use authorization May 1. State health departments are distributing it within their states.

Remdesivir is an intravenous drug that…

Philips lands 510(k) to market ultrasound systems for COVID-19

The FDA has granted Royal Philips (NYSE:PHG) 510(k) clearance to market a wide range of its ultrasound systems to help manage COVID-19-related lung and cardiac complications.

Handheld and portable ultrasound solutions in particular have become valuable tools for clinicians treating COVID-19 patients due to their imaging capabilities, portability and ease of disinfection, according to Philips.

The 510(k) clearance, which Philips called an industry first, allows the Netherlands-based company to provide detailed, practical guidance to support clinicians using its systems and software for COVID-19 patients. The clearance applies to Philips’ EPIQ series, Affiniti series, Lumify, CX50 and Sparq diagnostic ultrasound systems, and to off-cart solutions like QLAB advanced quantification software.

Ultrasound has shown value in imaging peripheral lung tissue affected by pneumonia, which is closely tied to COVID-19 lung complications, according to Philips. As …