Alpha Software Corp., of Burlington, Mass., released a multi-language update to its COVID-19 risk assessment app.
Aptargroup Inc., of Crystal lake, Ill., submitted an application to the German Federal Institute for Drugs and Medical Devices for emergency use authorization or its Activshield technology for use in disinfecting FFP2 masks.
Atrion Corp., of Allen, Texas, suspended its 2020 financial guidance, citing risks and uncertainties around the COVID-19 pandemic.
Beroni Group, of New South Wales, Australia, said it has identified 24 types of nanobodies that can be used for rapid detection and treatment of SARS-CoV-2, the virus that causes COVID-19. The company is preparing to conduct animal studies and clinical trials, with results expected in 12-18 months. Separately, Beroni said it has been approved by China’s Ministry of Commerce to export its SARS-CoV-2 IgG/IgM antibody detection kit globally.
Elmwood Park, N.J.-based Bioreference Laboratories Inc., an Opko Health company, reported the launch of COVID-19 antibody screening available to New York residents in partnership with New York City Health and Hospital Corp. Testing initially will be performed for 140,000 residents at five locations across all five boroughs, with more testing sites to open in the next several weeks. Test results will be available through Bioreference's Patient Portal, accessible by smartphone, tablet, desktop or U.S. Mail and become available within one to three days, on average.
Atlanta-based Cryolife Inc. has begun enrolling patients in its PROACT Xa clinical trial, a prospective, randomized study to assess whether patients with an On-X mechanical aortic valve can be maintained safely and effectively on axipaban rather than warfarin.
Singapore-based Fullerton Health reported the launch of its COVID-19 symptom checker and chat function on its Livefuller mobile application platform in the Singapore. The integrated health system plans to make the tools available for free across Asia Pacific.
Guardant Health Inc., of Redwood City, Calif., said it is withdrawing its previously announced financial guidance for 2020 due to the coronavirus pandemic.
Helius Medical Technologies Inc., of Newtown, Pa., has withdrawn its full-year outlook as a result of uncertainty due to the COVID-19 pandemic.
Livinguard AG, of Zug Switzerland, said that its technology for disinfecting textiles has been shown, through scientific testing, to destroy human coronavirus 229e.
Orthofix Inc., of Lewisville, Texas, is withdrawing its previously announced first-quarter and fiscal year 2020 guidance.
Twist Bioscience Corp., of South San Francisco, said it thought it prudent to withdraw financial guidance for fiscal 2020 in the wake of the COVID-19 pandemic.
United Health Products Inc., a Henderson, Nev.-based manufacturer and marketer of Hemostyp, received correspondence from the U.S. FDA regarding its current PMA class III submission for use in surgical applications. The company continues to coordinate and respond to FDA information requests in a timely manner.