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
ABM Respiratory Care’s Cough Therapy Device Cleared by FDA April 3, 2020 The system breaks up thick secretions in the lungs. Read More
FDA Clears Sectra’s Digital Imaging Module April 3, 2020 The module enables pathologists to review current and historical images and related data. Read More
ElectroCore Seeks EUA for Vagus Nerve Stimulation Therapy April 3, 2020 The device is cleared in the U.S. for treating acute pain associated with migraines Read More
Tissium Receives CE Mark for Sterile Surgical Sealant April 2, 2020 The device is indicated for use as an adjunct to sutures in vascular reconstruction. Read More
Wontech Gets FDA Clearance for Laser Device April 2, 2020 The laser features a skin-cooling spray feature that reduces patient discomfort from pain, swelling and redness. Read More
Bodysphere Backtracks on Emergency Use Authorization for COVID-19 Diagnostic April 2, 2020 The company’s CEO said the confusion about the authorization does not invalidate the test kit’s effectiveness. Read More
FDA Clears First Coronavirus Antibody Test for Use During Pandemic April 2, 2020 The diagnostic can only be run in laboratories deemed capable of performing moderate and high complexity tests, the agency said. Read More
OncoSil’s Pancreatic Cancer Treatment Gets CE Mark April 1, 2020 The device also received the FDA’s breakthrough device designation. Read More