Category: CERTIFICATIONS

Spectrumedics Announces CE Mark Approval For Its Coronary Intravascular Lithotripsy System

January 12, 2026

SINGAPORE, Jan. 6, 2026 /PRNewswire/ — Spectrumedics Medical (hereinafter “Spectrumedics”) is pleased to announce that its Sonico-CX Intravascular Lithotripsy (IVL) System has obtained CE Mark certification under the European Union Medical Device Regulation (EU MDR). The system comprises the Sonico-CX Coronary Intravascular Lithotripsy Catheter and the Intravascular Lithotripsy Generator.

Saluda Medical Receives Regulatory Approval for EVA™ Sensing Technology in Europe with recognition in Australia

January 8, 2026

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 wins CE mark for Versius in pediatric procedures

January 8, 2026

CMR Surgical announced today that it received CE mark and U.K. approval for its Versius surgical robot in pediatric surgery.

Siemens Healthineers wins FDA nod for helium-free MRI system

January 8, 2026

Siemens Healthineers announced today that it received FDA clearance for its 70cm bore Magnetom Flow magnetic resonance imaging (MRI) platform.

Sky Labs Secures CE-MDR for ‘CART PLATFORM,’ Accelerating Its Global Market Entry

January 8, 2026

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 wins FDA clearance for earbud-based EEG

January 7, 2026

Naox Technologies has received FDA 501(k) clearance for its wired electroencephelography (EEG) earphones, Naox Link.

Stereotaxis MAGiC cardiac ablation catheter wins FDA approval

January 6, 2026

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.