DiaSorin to Launch COVID-19 Test in Italy April 14, 2020 The company hopes to get CE mark certification and the FDA’s Emergency Use Authorization by the end of the month. Read More
FDA Grants Emergency Use for N95 Respirator Sterilizers April 14, 2020 The sterilizers will help increase the availability of respirators, the agency said. Read More
Bayer Launches Eye Drug Syringe in Europe April 13, 2020 The approvals applies to all EU states and to the UK, Iceland, Norway and Liechtenstein. Read More
Abbott Earns CE Mark for Tricuspid Valve-Repair Device April 13, 2020 The device reduces blood backflow. Read More
FDA Clears First Generic Proventil Inhaler April 13, 2020 FDA Commissioner Stephen Hahn said the agency recognizes the increased demand for albuterol products during the pandemic. Read More
DiaCarta Gets Emergency Use Authorization for COVID-19 Diagnostic April 13, 2020 The company said it can produce 500,000 tests a week. Read More
FDA Clears OrthoSensor’s Knee Implant Sensor April 9, 2020 The sensor helps surgeons to evaluate ligament balance and the position of the knee implant. Read More
Genetron Health Gains CE Mark for COVID-19 Test April 9, 2020 The company has also applied to the FDA for emergency use authorization. Read More
Olympus Grabs FDA’s De Novo Status for BPH Treatment April 8, 2020 BPH, or prostate gland enlargement, is a common disease in older men that frequently causes lower urinary tract symptoms. Read More
DiaSorin Shares Progress on COVID-19 Antibody Test April 8, 2020 The antibody test will be made available in the coming days for clinical trials. Read More
Outset Medical’s Dialysis System Gets Additional FDA Clearance April 7, 2020 Outset highlighted the increased need for home dialysis during the COVID-19 pandemic. Read More
Co-Diagnostics’ COVID-19 Test Gets EUA April 7, 2020 The test uses the company’s patented technology to significantly reduce errors. Read More