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    Regulatory Approvals

    Anumana receives FDA clearance for ECG-AI Cardiac Amyloidosis algorithm, using a standard 12-Lead ECG

    Anumana, a leader in cardiovascular AI, announced U.S. Food and Drug Administration (FDA) clearance of its ECG-AI algorithm for cardiac amyloidosis (CA) – the...

    CorTec Receives FDA Breakthrough Device Designation for Its Brain Interchange System in Stroke Rehabilitation

    CorTec GmbH, a pioneer in fully implantable brain-computer interfaces (BCI), announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation...

    FDA grants 510(k) clearance for Allevion Medical’s Vantage system

    Allevion Medical has secured the US Food and Drug Administration (FDA) 510(k) clearance for Vantage, a fully disposable and sterile system intended to simplify...

    Vdyne wins FDA IDE to study tricuspid valve replacement

    Vdyne announced that it received FDA investigational device exemption (IDE) for a pivotal trial evaluating its heart valve system. Maple Grove, Minnesota-based Vdyne develops a...

    Butterfly Network wins FDA clearance for GA AI ultrasound tool

    Butterfly Network announced that it received FDA clearance for a fully automated gestational age (GA) tool for its handheld ultrasound. Burlington, Massachusetts–based Butterfly develops a...

    Serenity Medical earns FDA HDE for cerebral venous stent

    Serenity Medical announced that it received FDA Humanitarian Device Exemption (HDE) approval for its novel River stent. Harrison, New York-based Serenity said approval makes River...

    Medtronic wins CE mark for OmniaSecure pacemaker lead

    Medtronic announced CE mark approval and the first commercial European implants for its OmniaSecure system. The OmniaSecure defibrillation lead connects to an implantable defibrillator. It...

    Anumana secures FDA clearance for ECG-AI algorithm

    Anumana, a leader in cardiovascular AI, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its pulmonary hypertension (PH) algorithm, an AI-enabled...

    Neurovalens receives EU MDR compliance for sleep insomnia device

    Northern Irish company Neurovalens has received the EU Medical Device Regulation (MDR) compliance for its prescribed insomnia device, Modius Sleep. This product is now approved...
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