Medtronic (NYSE: MDT)+
announced today that the FDA granted 510(k) clearance for its MiniMed Go app for multiple daily injections (MDI).
MINNEAPOLIS, Jan. 8, 2026 /PRNewswire/ — Saluda Medical, Inc. (ASX:SLD, “Saluda” or the “Company”), a commercial-stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed-loop neuromodulation platform, announced that, as expected, its next-generation EVA™ Sensing Technology has now received CE certification for commercialization in Europe with recognition of this approval in Australia. This follows FDA approval of EVA in December 2024.
CMR Surgical announced today that it received CE mark and U.K. approval for its Versius surgical robot in pediatric surgery.
Siemens Healthineers announced today that it received FDA clearance for its 70cm bore Magnetom Flow magnetic resonance imaging (MRI) platform.
SEOUL, South Korea, Jan. 8, 2026 /PRNewswire/ — Sky Labs (CEO Jack Byunghwan Lee) announced on the 8th that its ring-type blood pressure monitor, ‘CART PLATFORM,’ recently obtained the European Union’s Medical Device Regulation (CE-MDR) certification.
Naox Technologies has received FDA 501(k) clearance for its wired electroencephelography (EEG) earphones, Naox Link.
Stereotaxis (NYSE:STXS) has won FDA approval for its robotically navigated MAGiC ablation catheter, offering a minimally invasive option for patients who otherwise might not be eligible for cardiac ablation to treat complex and critical heart rhythm disorders.
W.L. Gore & Associates announced today that the FDA approved its Viabahn Fortegra venous stent, formerly known as Viafort.
BrainSpace announced that the FDA granted 510(k) clearance for its Intellidrop automated brain fluid management system.
Ceribell (Nasdaq:CBLL) announced today that the FDA granted breakthrough device designation for its large vessel occlusion (LVO) stroke detection monitor.