Forcing manufacturers to repurpose their production lines to make equipment to fight the coronavirus epidemic might actually hurt the U.S. supply of those items, the head of medtech trade group AdvaMed said today. AdvaMed officials have talked with U.S. secretary of Health and Human Services Alex Azar and FDA commissioner Dr. Stephen Hahn about medtech […]
DeviceTalks Weekly Podcast: Deconstructing medtech’s alphabet soup – DPA, MDR, FDA are all in the news
In this week’s DeviceTalks Weekly, we’ll examine how governmental effort, both foreign and domestic, are hitting the medtech industry. Our guests include Tracy Eberly, CEO of Fang Consulting, a regulatory advisory group. Eberly will update listeners on what pushing back the MDR deadline could mean for medtech companies and why some companies may be less […]
Thermo Fisher Scientific wins CE mark for COVID-19 test
Thermo Fisher Scientific (NYSE:TMO) announced that it received CE Mark approval in Europe for the use of its diagnostic test in detecting nucleic acid from the SARS-CoV-2 virus that causes COVID-19. The Waltham, Mass.-based company’s test uses Applied Biosystems’ TaqPath assay and real-time PCR technology. It is designed to provide results within four hours of a […]
FDA says it’s open to EUAs for ventilators to treat coronavirus
Amid a shortage of ventilators for treating coronavirus, the FDA put out a statement confirming its stance on issuing emergency use authorizations for potential temporary fixes. The FDA said it is operating on the basis of a EUA determination that the U.S. Dept. of Health and Human Services issues on Feb. 4. Earlier this week, […]
FDA warns against at-home COVID-19 tests
The FDA is warning consumers against unauthorized COVID-19 test kits marketed for use in the home. The agency said it has not authorized any diagnostic test for the virus for at-home use, nor has it endorsed any prevention or treatment claims that individual companies have made. The FDA also said it is not naming any […]
Thermo Fisher lines up financing for Qiagen buy
Thermo Fisher Scientific (NYSE:TMO) confirmed in a prospectus supplement that it is in part financing its $11.5 billion purchase of Qiagen (NYSE:QGEN) with an offering worth $2.2 billion. The offering includes $1.1 billion in 4.133% senior notes due in 2025 and another $1.1 billion in 4.497% senior notes due in 2030. Thermo Fisher said in its prospectus […]
FDA allows use of AliveCor’s Kardia device for COVID-19 patients
AliveCor announced that the FDA now allows the company’s KardiaMobile 6L electrocardiogram (ECG) for use in measuring QTc (a heart rhythm disorder that can potentially cause fast, chaotic heartbeats) in patients with COVID-19. The Mountain View, Calif.-based company touts its KardiaMobile 6L as the world’s only six-lead personal ECG. It is designed to detect potentially […]
FDA to authorize certain imported respirators for healthcare worker use
The FDA said yesterday that certain imported respirators (FFRs) may be eligible for emergency use authorization (EUA) to protect public health and safety during the coronavirus outbreak. The FDA said these these devices, imported from Australia, Brazil, Europe, Japan, Korea and Mexico, may be effective in protecting healthcare workers from airborne COVID-19 particulates, “based on […]
FDA advises on increasing supply for PPE
The FDA today said it is taking action to increase U.S. supplies to support the manufacturing of personal protective equipment and other devices in response to COVID-19. The FDA said it is facilitating access to critical personal protective equipment (PPE) and devices by engaging with importers and others involved in the import trade community during […]
Cepheid wins emergency use nod from FDA for bedside coronavirus test
Danaher Corp. (NYSE:DHR) subsidiary Cepheid announced that it received emergency use authorization from the FDA for its bedside Xpert Xpress SARS-CoV-2 test for detecting the virus causing the COVID-19 outbreak. The rapid molecular diagnostic test is designed to detect the SARS-CoV-2 virus causing coronavirus while operating on any of Cepheid’s GeneXpert systems worldwide, with a detection […]
7 ways the coronavirus is affecting medtech
Medtech companies face some tough times as the deadly coronavirus pandemic gains steam. But could this be the medical device industry’s Dunkirk, too? Just days ago, MassMEDIC president Brian Johnson made a call-out on LinkedIn for people to send ideas about how Massachusetts medical device companies could help fight COVID-19. He drew an analogy to […]
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