LifeVac receives FDA De Novo classification for anti-choking device
March 9, 2026
LifeVac is approved for use as a single-use, non-powered, non-invasive airway clearance device.
LifeVac is approved for use as a single-use, non-powered, non-invasive airway clearance device.
Philips (NYSE: PHG)+ announced today that it received FDA 510(k) clearance for its SmartHeart planning solution.
The FDA’s expanded clearances broaden the application of Bayer’s Medrad MRXperion system across a wider range of MR settings.
BD (NYSE: BDX)+ announced today that it received CE mark approval for its Revello vascular covered stent system.
LOS ALTOS, Calif., March 4, 2026 /PRNewswire/ — XYRA LLC announces that the US Patent and Trademark Office (USPTO) has issued a patent (No. 12,551,706) protecting the use of dose adjusted budiodarone for the treatment of atrial fibrillation (AF), with monitoring to correspondingly reduce or delay the risk of stroke and/or congestive heart failure.
TUCSON, Ariz., March 4, 2026 /PRNewswire/ — Delta Development Team, Inc., an industry leader in ruggedized thermal systems for medical and emergency applications, announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,566,016 covering its groundbreaking Autonomous Portable Refrigeration Unit (APRU-6L).
BROOKLYN PARK, Minn., March 4, 2026 /PRNewswire/ — Airiver Medical, a clinical stage company developing technologies to help patients who suffer from certain respiratory tract conditions, was granted designation as a Breakthrough Device from the U.S. Food and Drug Administration (FDA) for its Airiver Pulmonary Drug Coated Balloon (DCB) to treat central airway stenosis.
OSLO, Norway, March 3, 2026 /PRNewswire/ — Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that its core product APL-1702 (trade name: CEVIRA®), has received the Drug Registration Certificate from China’s National Medical Products Administration (NMPA), enabling commercial launch in China.
LILSE, Ill., March 3, 2026 /PRNewswire/ — Hubly Surgical has been awarded a Breakthrough Technology Designation for Neurosurgical Products with Premier, Inc. Premier offers Breakthrough Technology designations to innovations that offer a major advantage in terms of patient safety, clinical outcomes and operational efficiencies.
TORONTO and DALLAS, March 3, 2026 /PRNewswire/ – Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) (“Perimeter” or the “Company”), a commercial-stage medical technology company, announced today that it has received U.S. Food and Drug Administration (“FDA”) premarket approval (“PMA”) for Claire™ (formerly the Perimeter OCT B-Series with ImgAssist AI 2.0), the first AI-enabled imaging device approved in the United States for intraoperative breast cancer margin assessment.