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    Regulatory Approvals

    Pulnovo earns two FDA IDE nods for hypertension treatment

    Pulnovo Medical announced it received two FDA investigational device exemption (IDE) approvals for its technology. Shanghai-based Pulnovo won IDEs for its pulmonary artery denervation (PADN)...

    Centinel Spine wins MDR certification for its prodisc cervical TDR systems

    Centinel Spine, the leading global medical device company focused exclusively on treating cervical and lumbar spinal disease with the most complete and clinically-proven total...

    FDA clears Naitive’s AI osteoporosis screening tool OsteoSight

    UK-based Naitive Technologies has gained 510(k) clearance from the US Food and Drug Administration (FDA) for OsteoSight, an artificial intelligence (AI)-powered software for bone...

    inTRAvent Medical wins FDA clearance for SOLOPASS 2.0 navigation system

    inTRAvent Medical Partners LP, a medical device company dedicated to bringing intra-operative imaging and navigation to the bedside to improve neurosurgical procedures, today announced...

    Varian wins CE Mark for Embozene microspheres in knee osteoarthritis

    Varian announced its Embozene microspheres have received CE mark for genicular artery embolisation (GAE) to treat knee osteoarthritis. The regulatory clearance makes Embozene the first...

    Neurescue gains CE mark for non-shockable cardiac arrest catheter

    Danish medtech company Neurescue has gained a European CE mark for its catheter to address non-shockable cardiac arrest. The company’s catheter is used in conjunction...

    FDA clears Microbot’s LIBERTY endovascular robot

    The US Food and Drug Administration (FDA) has cleared Microbot Medical’s LIBERTY, a single-use, remotely operated robotic system for peripheral endovascular procedures. Microbot completed the...

    Lifeward wins CE mark for ReWalk 7 personal endoskeleton

    Lifeward (Nasdaq:LFWD) received CE mark approval for its ReWalk 7 personal exoskeleton. ReWalk 7, the seventh generation of the company’s personal exoskeleton, includes a number...

    ClearPoint Neuro wins expanded clearance for Prism Neuro Laser Therapy System

    ClearPoint Neuro, a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced that the ClearPoint Prism...
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