Memorial Sloan Kettering Cancer Center in New York is reportedly experiencing shortages of masks and other protective equipment as demand continues to skyrocket during the global coronavirus pandemic. Buzzfeed reported earlier this week that a transcript from a staff meeting on March 13 revealed that the hospital had just one week’s supply of masks in […]
coronavirus
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.
Moody’s lowers outlook for U.S. medtech industry due to coronavirus
Moody’s Investors Service has lowered its outlook for the U.S. medical device industry due to lower sales it expects from the coronavirus outbreak. The Wall Street ratings service said yesterday that it has revised its EBITDA forecast for the next 12 to 18 months to 2% to 4% from 5% to 6%, but added that […]
European Commission moves to protect personal protective equipment availability during COVID-19
The European Commission this week said it has taken immediate steps to protect the availability of supplies of personal protective equipment in the wake of COVID-19. The Commission is requiring that exports of such equipment outside of the European Union to be subjected to an export authorization by member states. “The challenges presented by the […]
FDA lets states approve COVID-19 tests
The FDA has issued an unprecedented new guidance that allows individual states to approve diagnostic tests for COVID-19. The guidance also describes a policy regarding the use of serological testing for antibodies to the virus without an emergency use authorization (EUA). The new guidance allows commercial manufacturers to more rapidly distribute their validated SARS-CoV-2 diagnostics […]
Quest Diagnostics, Quidel Corp. get emergency nod for COVID-19 tests
The FDA has granted two more companies’ COVID-19 tests emergency use authorizations. Tests by Quest Diagnostics (NYSE:DGX) and Quidel Corp. (NSDW:QDEL) got the nod for distribution within the U.S. without prior clearance or approval. Quest Diagnostics (Secaucus, N.J.) said it will expand testing with its new COVID-19 diagnostic this week from its high-complexity laboratories in Chantilly, Va., […]
How will coronavirus affect medtech companies that rely on elective surgeries?
One thing is likely to hurt some medtech companies more than others during the coronavirus pandemic: an elective surgical procedure slowdown. This thought had begun to emerge last week among industry watchers, but a pair of tweets over the weekend gained thousands of “likes” and retweets. The American College of Surgeons called for hospitals to […]
COVID-19 investigational vaccine clinical trial underway
A Phase 1 clinical trial for an investigational COVID-19 vaccine is underway at Kaiser Permanente Washington Health Research Institute in Seattle. The open-label trial plans to enroll 45 healthy adults aged 18 to 55 years over a six week period. The first study participant received the vaccine yesterday. Researchers at Kaiser Permanente Washington Health Research […]
Hologic, LabCorp gain FDA emergency testing nods
The FDA has granted emergency use authorization for COVID-19-related diagnostic tests to Hologic (NSDQ:HOLX) and Laboratory Corporation of America (NYSE:LH). Hologic described its new Panther Fusion SARS-CoV-2 assay as a molecular diagnostic test that detects SARS-CoV-2, the virus that causes COVID-19. The automated Panther high-throughput system is widely used across the U.S., can provide results […]
COVID-19 test development surges with pandemic
Companies around the world are racing to develop and distribute tests for COVID-19 to laboratories and to market other products and services they say can help patients and healthcare providers cope with the pandemic. On March 13, the FDA gave Thermo Fisher Scientific (NYSE:TMO) emergency use authorization (EUA) for a diagnostic test that certain U.S. laboratories […]
DeviceTalks Weekly: How is coronavirus affecting medtech?
Welcome to the DeviceTalks Weekly podcast, a regular – and sometimes irregular – opportunity to visit with the editorial team at MassDevice and Medical Design & Outsourcing. This week, Chris Newmarker, executive editor, life sciences, at WTWH Media, reviews our COVID-19 coverage with Tom Salemi, editorial director, DeviceTalks. Tom also chats with Jeffries analyst Raj […]
BD seeks authorization for COVID-19 tests
Becton Dickinson (NYSE:BDX) said today it will submit an emergency use authorization request this week to the FDA for a coronavirus test that could be used on the BD Max molecular diagnostic system. The diagnostic system is used in hundreds of laboratories across the U.S., according to the company. “BD is also exploring the development of […]