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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 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 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 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, 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...
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...
4DMedical Limited, the global leader in cardiothoracic imaging software, announces that its latest imaging technology, CT:VQ™ has received CE Mark certification for commercial use...
Pixee Medical, a pioneer in Augmented Reality (AR) guidance for orthopedic surgery, announced it has received CE mark for Knee+ NexSight, its new AR-based...
Meril Life Sciences has secured CE marking for its MISSO robotic surgical system, a regulatory milestone bringing the platform into compliance with the stringent...
