The U.S. is one of many countries facing new restrictions, quarantines and, due to high demand, shortages of important medical equipment to help combat the coronavirus pandemic. As hospitals and healthcare facilities report the need for more equipment, and with the government potentially invoking a statute that could ramp up protective equipment manufacturing even more, […]
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.
Lucence, Carbon Health tout COVID-19 test kits
Singapore-based Lucence said it has developed a sample collection device for viral infections such as COVID-19. Unlike other companies’ tests, Lucence’s SAFER-Sample (Stabilization of nucleic Acid Formulation for Evaluation of RNA) does not require samples from nose or throat swabs to be chilled for transport to a lab, according to the company. It comes with […]
Masimo acquires TNI Medical
Non-invasive monitoring technology developer Masimo (NSDQ:MASI) announced that it plans to acquire German ventilation company TNI Medical for an undisclosed amount. Irvine, Calif.-based Masimo pulled the trigger on the acquisition after it disclosed an investment in August 2019 that included an exclusive option to purchase Würzburg, Germany-based TNI. Masimo expects to close the deal in the […]
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 […]
Everlywell, Nurx to offer at-home COVID-19 tests
Home testing company Everlywell said today that it will launch a home test kit with telehealth diagnosis for COVID-19 on Monday. The Austin, Texas-based company said it will release 30,000 tests immediately and is working with multiple labs to have testing and diagnosis capacity for a quarter of a million people weekly. Consumers who have […]
Major U.S. manufacturers answering call for ventilator needs
U.S. manufacturers — inside and outside medtech — are offering help amid shortages of ventilators, respirator masks and more needed to combat coronavirus. News broke this week that Memorial Sloan Kettering Cancer Center in New York is reportedly experiencing shortages of masks and other protective equipment, and it is not alone in that regard. Last […]
CMS recommends postponing most elective procedures
The Centers for Medicare and Medicaid Services (CMS) released guidance late yesterday asking healthcare providers to postpone adult elective surgeries and procedures, including dental procedures, until further notice. The move is an attempt to preserve the supply of ventilators and personal protective equipment such as masks and gowns while protecting patients and staff from exposure […]
Abbott receives FDA emergency use authorization for coronavirus test
Abbott (NYSE:ABT) has received FDA emergency use authorization for a molecular test for novel coronavirus (COVID-19). The company said yesterday that it will immediately ship 150,000 of its RealTime SARS-CoV-2 EUA tests to existing customers in the U.S. Customers can use the tests on Abbott’s m2000 RealTime system, and Abbott will deploy additional m2000 systems as needed. […]
FDA pauses domestic inspections due to coronavirus
The FDA announced today that it has temporarily suspended all routine domestic inspections of regulated facilities during the coronavirus outbreak. The move is designed to protect agency employees as well as those who conduct inspections for the agency under contract at the state level and from a desire by regulated facilities to restrict visitors, according […]
Sterigenics asks to reopen Georgia EtO plant to fight coronavirus
Sterigenics has asked Cobb County, Ga. officials for permission to reopen its medical device sterilization plant to aid in the fight against the coronavirus. Oak Park, Ill.-based Sterigenics temporarily shut the Atlanta plant on August 26 to voluntarily upgrade emission controls for ethylene oxide (EtO), the carcinogenic gas it used to sterilize medical devices. In September, […]
Trump invokes Defense Production Act against coronavirus
President Trump announced today that he is invoking the Defense Production Act — a Korean War–era law that enables extraordinary government actions to boost needed supplies — “just in case we need it” to fight the coronavirus pandemic. There have been stories of healthcare providers across the United States facing shortages of everything from ventilators […]