Terumo wins FDA 510(k) for next-gen bypass surgery monitoring
May 30, 2024
Terumo Cardiovascular today announced FDA 510(k) clearance of its next-generation CDI OneView monitoring system.
Terumo Cardiovascular today announced FDA 510(k) clearance of its next-generation CDI OneView monitoring system.
HALO AP Dx brings digital primary diagnosis to anatomic pathology labs in the US.
Canary Medical announced today that it received FDA breakthrough device designation for its Canturio lumbar cartridge.
Medtronic (NYSE: MDT)+
announced today that the FDA granted breakthrough device designation for its Infuse bone graft.
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 announced today that the FDA granted 510(k) clearance for its Inumi Flex endoscopic needle with the Aliya system for soft tissue ablation.
CamDiab announced today that the FDA granted authorization for its CamAPS FX advanced adaptive closed-loop artificial pancreas app.
CorTec announced today that the FDA approved an investigational device exemption (IDE) application for its closed-loop brain-computer interface (BCI)
The use of the Indica Labs HALO AP Dx software for review of images acquired with the NanoZoomer® S360MD Slide scanner produced by Hamamatsu brings another option for digital primary diagnosis to anatomic pathology laboratories.
Medtronic (NYSE: MDT)+
officials say the company received FDA clearance for the next-generation PillCam Genius SB capsule endoscopy kit.