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    FDA approves Medtronic’s In.Pact 018 drug-coated balloon catheter

    Medtronic  announced that it received FDA approval for its In.Pact 018 paclitaxel-coated balloon catheter. Fridley, Minnesota-based Medtronic’s In.Pact 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon...

    OmniGuide Holdings Receives FDA Clearance for RevoLix™ HTL Hybrid Thulium Laser for the treatment of BPH and Stones

    OmniGuide Holdings (OGH) , the U.S. Food and Drug Administration cleared RevoLix™ HTL a family of pulsed and continuous wave Thulium YAG lasers is the foundation...

    Revolutionary Wearable Ultrasound Device Gains FDA Approval

    Manamed, a pioneering Medical Technology development company, has been granted FDA approval on its latest orthopedic recovery device, ManaSport. LAS VEGAS, May 26, 2022 /PRNewswire/ -- ManaMed...

    inHEART RECEIVES FDA CLEARANCE FOR NOVEL 3D CARDIAC MODELING SOLUTION

    System creates 3D models of the heart with unprecedented anatomical details, allowing physicians to better plan and personalize therapeutic interventions  inHEART, a privately-held medical device...

    RapidAI receives FDA 510(k) to identify potential pulmonary embolism

    The Rapid PE Triage & Notification tool analyzes CT pulmonary angiograms to find potential cases and alert care teams. RapidAI, a health tech company that...

    CVRx receives FDA approval for MR labelling for Barostim

    CVRx, a developer of a neuromodulation device to treat the symptoms of heart failure, has received U.S. Food and Drug Administration (FDA) approval for magnetic...

    New FDA clearance expands indications for Xact Robotics’ ablation system

    Xact Robotics announced that it received FDA clearance for a modification to its Xact Ace robotic system for ablation procedures. Hingham, Massachusetts-based Xact Robotics’ FDA...

    RadNet Artificial Intelligence Subsidiaries, DeepHealth and Quantib, Obtain FDA Clearance for Mammography and Prostate AI Tools

    RadNet, Inc., announced that it has received FDA clearances for its DeepHeatlh Saige-DX™ mammography and Quantib® Prostate 2.0 MRI artificial intelligence ("AI") algorithms. Saige-DX: AI Mammography Diagnostic...

    Medtronic receives FDA approval for latest generation drug-eluting coronary stent system

    The Onyx Frontier™ drug-eluting stent offers an innovative delivery system and builds upon the acute performance and clinical data from the Resolute Onyx™ drug-eluting stent....

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