MedTech News
Comar Achieves CE Certification for Medical Devices Under New EU MDR Regulations
BUENA, N.J., May 29, 2024 /PRNewswire/ — COMAR, a leading provider of innovative medical devices and packaging solutions, is thrilled to announce a significant achievement. After rigorous preparation, they successfully obtained their CE certificate under the latest EU Medical Device Regulations (EU MDR 2017/745).
Indica Labs receives first FDA clearance for HALO AP Dx digital pathology platform
HALO AP Dx brings digital primary diagnosis to anatomic pathology labs in the US.
Canary Medical wins FDA breakthrough nod for smart spine tech
Canary Medical announced today that it received FDA breakthrough device designation for its Canturio lumbar cartridge.
Medtronic wins FDA breakthrough nod for Infuse bone graft in TLIF
Medtronic (NYSE: MDT)+
announced today that the FDA granted breakthrough device designation for its Infuse bone graft.
INSPIRA™ ART100 Receives FDA 510(k) Clearance
RA’ANANA, Israel, May 28, 2024 /PRNewswire/ — Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the “Company”, “Inspira”, or “Inspira Technologies”), a breakthrough medical technology company, today announced that it has received notification of 510(k) class II clearance from the U.S. Food and Drug Administration (FDA) for its INSPIRA™ ART100, a Cardiopulmonary Bypass System.
Galvanize wins FDA nod for pulsed electric field endoscopic needle
Galvanize announced today that the FDA granted 510(k) clearance for its Inumi Flex endoscopic needle with the Aliya system for soft tissue ablation.
J&J’s Ethicon launches new surgical stapler
Ethicon announced that it began the U.S. launch of its first-of-its-kind Echelon Linear surgical stapler.
HPV vaccines prevent cancer in men as well as women, new research suggests
New research suggests the HPV vaccine is preventing cancer in men, as well as in women, but fewer boys than girls are getting the shots in the United States.