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    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....

    Paige AI Solution for Prostate Cancer Biomarker Detection Receives CE-IVD and UKCA Marks

    Paige,a global leader in clinical AI applications in pathology, announced it received CE-IVD and UKCA marks for the Paige Prostate Biomarker Suite, an AI...

    Philips receives FDA 510(k) clearance for latest breakthrough high-performance MR 7700 system

    MR 7700 imaging system features an enhanced gradient system for unmatched performance and precision, delivering Philips’ highest image quality to help improve diagnostic outcomesNewest...

    CureApp: World’s First Medical Device Regulatory Approval of Digital Therapeutic App for Hypertension

    CureApp, Inc. (Head Office: Chuo-ku, Tokyo; CEO: Kohta Satake) was notified by the Ministry of Health, Labour and Welfare on April 26, 2022 that...

    iSono Health receives US FDA approval for breast imaging ultrasound system

    ATUSA scans the entire breast volume automatically and provides 3D visualisation of the tissue in just two minutes. iSono Health has received approval from the...

    FDA clears J&J’s Ethicon’s Monarch surgical robot for urology procedures

    Johnson & Johnson MedTech company Ethicon announced that its Monarch robotic surgery platform received FDA 510(k) clearance. Ethicon’s Auris Health subsidiary received the FDA clearance...

    Nanox Announces FDA Clearance for HealthOST Device, an AI Software Measuring Vertebral Compression Fractures and Low Bone Density, Which are Often Associated with Osteoporosis

    NANO-X IMAGING LTD ("Nanox" or the "Company," Nasdaq: NNOX), an innovative medical imaging technology company, announced that its deep-learning medical imaging analytics subsidiary, Nanox.AI, received...

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