The FDA today temporarily loosened its enforcement on ventilators and some related devices to address manufacturing limitations and supply shortages during the coronavirus pandemic. The agency issued a temporary guidance that also covers certain anesthesia machines, respirators, oxygen conservers and delivery devices for hospital or home use. The guidance describes a limited number of modifications […]
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.
5 companies on the front lines of the coronavirus fight
Nancy Crotti, Managing Editor and Danielle Kirsh, Senior Editor Amid the stock market roller-coaster ride that began last month, medtech companies that make devices and diagnostic tests vital to fighting COVID-19 may ultimately fare better than others, but it’s hard to tell until the virus peaks and people get back to work. At midafternoon today, […]
Smiths Medical ramps up ventilator production
Smiths Medical announced that it is increasing the production of its Parapac Plus ventilator to meet increased demand in the United Kingdom and across Europe. The company’s Luton, England site is where production will be ramped up over the next two weeks, according to a news release. Smiths is also working with contract manufacturers in […]
Conformis furloughs a third of its employees amid coronavirus pandemic
Conformis (NSDQ:CFMS) announced today that it is furloughing a third of its employees and tossed out its 2020 financial guidance amid the coronavirus crisis. The Billerica, Mass.–based orthopedic arthroplasty technology company’s furlough includes approximately 80 employees and substantially all of its temporary workforce, effective today. Conformis said it identified essential and non-essential functions to its business […]
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 […]
Medline to retool Wisconsin plant to produce hand sanitizer
Medline Industries said today that it will start making hand sanitizer at its Hartland, Wis. plant — with a goal of producing 150,000 bottles a week by mid-April to help Americans protect against coronavirus. The Northfield, Ill.–based medical supplies company is modifying equipment and ventilation systems for the new line. Hand sanitizer is one of the […]
MedTech Europe wants halt of EU MDR implementation amid coronavirus crisis
Trade association MedTech Europe announced today that it is calling on EU institutions to postpone the implementation of the new Medical Devices Regulation and In Vitro Diagnostics Regulation (IVDR) amid the outbreak of COVID-19. Medical device companies have been scrambling to meet the implementation of the new MDR and IVDR. May 26 has been a […]
Novacyt reports skyrocketing demand for its coronavirus test
Novacyt announced that its Primerdesign molecular diagnostics division sold and received orders for more than $10.1 million (£8.7 million) of its COVID-19 tests. The company’s United Kingdom–based molecular diagnostics arm offered the update on its CE-Marked, research-use-only coronavirus tests, having previously announced that it sold and received orders for over $5 million of its tests […]
Honeywell, 3M to ramp up N95 face masks production
Both Honeywell (NYSE:HON) and 3M (NYSE:MMM) will produce millions of additional N95 respirators to protect U.S. health care workers fighting the coronavirus pandemic. Honeywell (Charlotte, N.C.) said yesterday that it will expand operations at its Smithfield, R.I. eye protection products plant so that the plant can also manufacture millions of N95 masks. Honeywell said it will immediately […]
Trump says mere threat of using Defense Production Act is enough to fight coronavirus
President Donald Trump may have signed an executive order last week that invoked the decades-old Defense Production Act, but so far he isn’t using it to boost needed medical supplies to combat the coronavirus pandemic. Trump argued during a press briefing yesterday that the mere threat of using the Korean-War-era law was enough to get […]
DeviceTalks Weekly: Ep. 2 – Medtech goes to war with COVID-19
In this week’s DeviceTalks Weekly Podcast, we’ll talk about medtech’s essential role in the escalating war against COVID-19. We’ll visit with Fluidda CEO Jan De Backer and Kevin Thornal, division president of diagnostic solutions at Hologic. The executives will explain how their imaging and diagnostic devices – which both received recent FDA approval – will […]