The FDA grossly overestimated the number of coronavirus diagnostic tests that would be available this week as well as U.S. laboratories’ capacity to process them, according to a report in the New York Times. FDA commissioner Stephen Hahn told reporters on Monday that the agency’s decision allowing private labs to make their own tests would […]
Here at MassDevice — medtech's online business journal — we're covering news about the coronavirus (COVID-19) pandemic daily. Here is the latest about coronavirus and the medical device industry, regulatory changes related to the pandemic, new tests for the virus, vaccine development, and much more.
The FDA has authorized the use of certain industrial respirator masks for healthcare workers during the coronavirus outbreak. The N95 disposable filtering facepiece respirators have been approved by the National Institute for Occupational Safety and Health (NIOSH) as non-powered air-purifying particulate respirators. Healthcare workers will be allowed to use these, including those that have passed […]
FDA chief Stephen Hahn yesterday called on Congress to require medtech manufacturers to notify the agency of impending device shortages or supply-chain disruptions. The request is part of President Trump’s budget and has taken on new urgency with the spread of the coronavirus worldwide. The FDA does not have the same authorities for medical device […]
The FDA is unable to conduct medical device plant inspections in China because of the U.S. State Dept.’s travel advisory amid the coronavirus outbreak, the agency said in a statement today. While the FDA is unable to conduct inspections, it plans to rely on tools such as import screening, examinations, sampling and import alerts, along […]
Medtronic (NYSE:MDT) announced that, through the Medtronic Foundation, it is committing approximately $1.2 million to coronavirus relief efforts around the world. The company said its commitment to helping during the pandemic that is sweeping the globe includes cash contributions from the Medtronic Foundation and product donations from the company itself, according to a news release. Cash […]
Medical device companies all over have felt the impact of the coronavirus pandemic that originated in China. The latest figures from the World Health Organization (WHO) show that at least 600 people have died — almost all of them in China — with tens of thousands of confirmed coronavirus cases in dozens of countries. Demand […]