President Donald Trump yesterday invoked the Defense Production Act to reduce supply-chain problems for certain manufacturers to produce ventilators. In the executive order, the president gave the secretaries of the departments of Health & Human Services and Homeland Security the power to secure materials for General Electric (NYSE:GE), Hillrom (NYSE:HRC) , Medtronic (NYSE:MDT), ResMed (NYSE:RMD), Philips (NYSE:PHG) and Vyaire Medical. Ventilator […]
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.
New BD, BioGX coronavirus test can be run on-site at hundreds of U.S. hospitals
Becton Dickinson (NYSE:BDX) and BioGX announced today that the FDA granted emergency use authorization (EUA) to their new diagnostic test for screening for COVID-19 on-site at hospitals. The new test is designed as an easy-to-use, rapid diagnostic test to screen for coronavirus and receive results in under three hours, according to a news release. The assay detects […]
FDA eases mask regulations, seeks to boost decontamination of used masks
The FDA yesterday further relaxed regulations on medical and surgical masks and face shields to ease shortages during the coronavirus pandemic, and invited companies that decontaminate masks to submit proposals for emergency authorizations. In a new guidance, the agency also gave its blessing to healthcare providers to use improvised masks during the public health emergency […]
U.S. government distributes 192,000 N95 respirator masks taken from price gougers
The U.S. Departement of Justice and Department of Health and Human Services are taking 192,000 N95 respirator masks confiscated from price gougers and distributing them in New York and New Jersey — which are especially hard-hit by the coronavirus pandemic. HHS used its authority under the Defense Production Act to distributing the confiscated supplies, which […]
Trump slams 3M over foreign respirator sales, invokes DPA
President Donald Trump last evening blasted 3M (NYSE:MMM) for selling some of its N95 masks to other countries, hours after invoking the Defense Production Act to prioritize orders from the Federal Emergency Management Agency. “We hit 3M hard today after we saw what they were doing with their masks,” Trump tweeted Thursday night. “‘P Act’ all […]
FDA clears Cellex antibody test for COVID-19, not Bodysphere’s
The FDA yesterday informed Cellex that it is issuing emergency use authorization (EUA) for the company’s SARS-CoV-2 antibody test for detecting coronavirus. Cellex (Research Triangle Park, N.C.) is touting its rapid test as the first of its kind to receive authorization amid the coronavirus crisis. It is a lateral flow immunoassay designed for the qualitative […]
Could AI help monitor coronavirus disease progression?
Artificial intelligence radiology tech developer Qure.ai announced that it is working with the San Raffaele University Hospital in Milan to monitor disease progression in COVID-19 patients. The Mumbai-based company’s QXR automated chest X-ray system is designed to interpret a coronavirus patient’s lung scans within seconds, quantifying how much of their lungs have been affected by […]
Boston Scientific temporarily cutting hours for most of its U.S. workers
Boston Scientific (NYSE:BSX) announced today that it is taking actions in response to the COVID-19 pandemic, including pay cuts. In anticipation of an even larger impact from the coronavirus outbreak in the second quarter, the Marlborough, Mass.-based company said in a news release that it is taking proactive steps to reduce costs so it can […]
CHF Solutions increases production staff for Aquadex Smartflow due to COVID-19
CHF Solutions (NSDQ:CHFS) announced today that it is increasing the production staff that assembles its next-generation Aquadex SmartFlow consoles after increased demand from hospitals as a result of the COVID-19 pandemic. The Aquadex SmartFlow system is designed to remove excess fluid from patients suffering from hypervolemia (fluid overload). It is indicated for temporary (up to eight […]
Judge refuses to delay Elizabeth Holmes trial
Ex-Theranos CEO Elizabeth Holmes lost a bid to have the trial in her criminal fraud case delayed, despite pleas of hardship due to the COVIDd-19 outbreak. According to published reports, Holmes’ defense attorneys argued yesterday that travel and other restrictions related to the pandemic would hamper their client’s trial preparation efforts. They had filed motions […]
Siemens Healthineers seeking EUA for its coronavirus test kit
Siemens Healthineers (ETR: SHL) announced today that it is making its Fast Track Diagnostics (FTD) test kit for COVID-19 available as it seeks FDA emergency use authorization (EUA) and other forms of regulatory approval. The FTD SARS-CoV-2 assay kit is designed to diagnose infection by the SARS-CoV-2 virus that causes coronavirus. Siemens Healthineers is already shipping test […]