GE HealthCare wins FDA, CE mark approval for Allia Moveo image-guided platform
February 2, 2026
GE HealthCare (Nasdaq: GEHC)+
announced today that it received FDA 510(k) clearance and CE mark for its Allia Moveo platform.
GE HealthCare (Nasdaq: GEHC)+
announced today that it received FDA 510(k) clearance and CE mark for its Allia Moveo platform.
Medtronic (NYSE: MDT)+
today announced three U.S. milestones expanding access to its MiniMed 780G automated insulin delivery system.
Veritas.AI is designed to advance the functionality of Spectrum Dynamics’ VERITON-CT scanner for nuclear imaging.
Rystiggo is administered weekly, 3ml to 6ml over 15 to 30 minutes for six weeks.
MENLO PARK, Calif., Jan. 29, 2026 /PRNewswire/ — GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced the submission of the final module of the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its Galleri® multi-cancer early detection (MCED) test. The FDA designated the test as a Breakthrough Device in 2018.
SEOUL, South Korea, Jan. 29, 2026 /PRNewswire/ — NEXTBIOMEDICAL CO., LTD. (KOSDAQ: 389650), an innovative medical device company based in South Korea, announced today that Nexsphere-F™, the company’s novel fast resorbable microsphere for musculoskeletal pain embolization has received approval from Health Canada.
PITTSBURGH, Jan. 29, 2026 /PRNewswire/ — MolecuLight today announced that its MolecuLightDX® wound measurement has been qualified by the U.S. Food and Drug Administration (FDA) as a Medical Device Development Tool (MDDT). The FDA’s MDDT program qualifies select, scientifically validated tools for use in medical device development and evaluation, enabling sponsors to generate reliable, FDA accepted data in clinical investigations.
SARASOTA, Fla., Jan. 29, 2026 /PRNewswire/ — Spectrum Dynamics Medical, a global leader in digital nuclear medicine imaging solutions, today announced that it has received FDA 510(k) clearance for Veritas.AI™ Noise Reduction, its advanced artificial intelligence platform designed to significantly enhance image quality, diagnostic confidence, and operational efficiency on the VERITON-CT® digital SPECT/CT system.
Glucotrack (Nasdaq:GCTK) announced today that it received new U.S. patents for its continuous blood glucose monitoring (CBGM) platform.
The FDA has authorised up to 15 clinical sites to take part in the study.