Canary Medical wins FDA breakthrough nod for smart spine tech
May 29, 2024
Canary Medical announced today that it received FDA breakthrough device designation for its Canturio lumbar cartridge.
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.
ADDISON, Texas , May 16, 2024 /PRNewswire/ — FX received 510k clearance for its full-wedge augmented glenoid baseplates. The newly cleared baseplates bring 6 new options to the previously cleared portfolio. There are now a combined total of 18 glenoid baseplate options to the market to address a variety of surgeon needs. Augmented glenoid baseplate options have continued to become a growing solution for surgeons to address bone loss, defects, or complicated morphologies of the glenoid.
CARLSBAD, Calif., May 15, 2024 /PRNewswire/ — DCN Dx, a leading contract research organization for in vitro diagnostics, today acknowledges the FDA’s Emergency Use Authorization (EUA) of the WELLlife™ COVID-19/Influenza A&B Test, developed by Wondfo USA. This important authorization will enable healthcare professionals to differentiate rapidly between COVID-19 and influenza infections, enhancing patient care at the point-of-care.