Royal Philips (NYSE:PHG) announced that it has won FDA 510(k) clearance for a wearable biosensor to help manage confirmed and suspected COVID-19 patients in the hospital. The Amsterdam-based company described the BX100 biosensor as a wireless wearable sensor designed to help healthcare providers detect when COVID-19 patients in lower-acuity units are at risk for deterioration so […]
Steris wins second EUA to decontaminate up to 30m respirators per day
Steris (NYSE:STE) has won an FDA emergency use authorization (EUA) for a new steam sterilization method to decontaminate used N95 respirators. The EUA covers the new Steris Steam Decon cycle to decontaminate 3M 1860, 3M 1860S, and 3M 1804 NIOSH-approved N95 respirators that are or might be contaminated with SARS-CoV-2 and other pathogenic microorganisms. The FDA […]
FDA signals PPE shortage, issues EUA for more
The FDA has issued a call for manufacturers to produce more non-surgical gowns and other personal protective equipment (PPE) as the coronavirus pandemic makes its way across the country. The emergency use authorization issued Friday also listed conductive shoes and shoe covers, operating room shoes and shoe covers, surgical helmets and caps and other surgical […]
Ga. warehouse workers sue Sterigenics, ConMed over EtO exposure
Fifty-three people who worked in an Atlanta-area warehouse that stored medical devices sterilized by ethylene oxide (EtO) filed suit this week against Sterigenics and its parent company over exposure to the gas. The plaintiffs or their families claim that long-term EtO exposure to the sterilized devices, which they unloaded, handled, warehoused and distributed, caused multiple deaths, cancer, […]
Report: New Medtronic CEO challenges Trump on ‘reshoring’
New Medtronic (NYSE:MDT) CEO Geoff Martha openly disagreed yesterday with President Donald Trump’s mission to bring formerly U.S.-based companies back to this country, according to a report in the Irish Times. Medtronic, which maintains a U.S. headquarters in Fridley, Minn., bought Dublin-based Covidien for $50 billion in 2015 and moved its global headquarters to Ireland in […]
FDA eases regs on certain device changes during pandemic
The FDA will allow limited changes to certain devices so medtech companies can address manufacturing and supply chain issues due to COVID-19-related disruptions. In a guidance released yesterday, the agency said it would allow changes to devices approved through its premarket approval (PMA) and humanitarian device exemption (HDE) pathways as long as those changes do not create […]
15 heart devices that could boost their manufacturers’ sales
Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices. Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures. Now hospitals […]
Abbott: ID NOW COVID-19 results more accurate with earlier testing
Abbott (NYSE:ABT) said today that its ID NOW COVID-19 test works better on specimens collected soon after patients begin showing symptoms. The test’s performance has drawn fire from federal officials in recent weeks, including a recent FDA warning that the ID NOW test may return false-negative results. The agency granted the test an emergency use authorization […]
FDA launches COVID-19 research initiative
The FDA has entered an agreement with healthcare analytics company Aetion to research urgent questions about COVID-19. The New York City-based company said the research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns using relevant, novel data sources and analyzing these data according to […]
Health Canada authorizes Abbott COVID-19 antibody test
Abbott (NYSE:ABT) announced today that Health Canada has granted interim authorization for its Architect SARS-CoV-2 IgG serology test for COVID-19. The Abbott Park, Ill.-based company won an FDA emergency use authorization and the CE Mark for the same antibody test for use on its Architect system in April. The test is designed to detect the IgG […]
LivaNova touts results of VNS treatment for bipolar depression
LivaNova (NSDQ:LIVN) today announced the publication of a new study that showed adding vagus nerve stimulation (VNS) therapy to treatment-as-usual significantly improves outcomes in patients with treatment-resistant bipolar depression (TRBD). Published in the International Journal of Bipolar Disorders, the study examined patients from a 5-year prospective registry and found 63% of 97 patients treated with VNS plus […]