MedTech News

.................... by Andrew Celentano

Spectrumedics Announces CE Mark Approval For Its Coronary Intravascular Lithotripsy System

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.

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Wearable sensors assist in developing safer and better home dialysis – HUS and VTT start testing with patients

ESPOO, Finland, Jan. 8, 2026 /PRNewswire/ — HUS Helsinki University Hospital and VTT are starting a field test of wearable sensors to develop home dialysis. A total of 36 volunteer patients will use the sensors that enable monitoring of treatment effectivity. Making home dialysis safer and better would improve life quality and save society millions of euros annually.

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

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.

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