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    Regulatory Approvals

    Peytant wins FDA de novo nod for covered stent system

    The FDA granted marketing authorization for Peytant Solutions' AMStent tracheobronchial covered stent system. Plymouth, Minnesota-based Peytant designed its AMStent to treat pulmonary obstructions caused...

    FDA clears Gentuity imaging system for coronary interventions

    Gentuity received FDA 510(k) clearance for its HF-OCT imaging system with the Vis-Rx micro-imaging catheter. Sudbury, Massachusetts-based Gentuity received approval for the technology for...

    Novocure wins FDA nod for lung cancer treatment wearable

    Novocure announced the FDA treated its Optune Lua wearable device for treating metastatic non-small cell lung cancer. Optune Lua uses tumor-treating fields (TTFields) to exert...

    CMR Surgical wins FDA clearance for next-gen Versius Surgical System

    CMR Surgical announced the U.S. FDA has granted marketing authorisation for the Versius Surgical System, paving the way for a next-generation versatile, adaptable, and...

    FDA greenlights Momentis’ robotic surgery device for hernia repair

    Momentis Surgical’s Anovo robotic surgical platform has secured 510(k) clearance from the US FDA for use in single-site, abdominal access ventral hernia repair. The device...

    Endostart wins CE mark to bring magnetic balloon tech to enteroscopy

    Endostart received CE mark approval for the expanded use of its flagship Endorail product. Certaldo, Italy-based Endostart designed Endorail to provide efficiency and safety...

    Astellas subsidiary Iota wins FDA IDE nod to study implantable bladder device

    Iota Biosciences, a subsidiary of Astellas Pharma, announced that it received FDA investigational device exemption (IDE) for its bladder implant. The FDA gave the go-ahead...

    FDA clears Vy Spine’s 3D printed spinal fusion device

    Vy Spine has received clearance for its 3D printed LumiVy OsteoVy PEKK Lumbar IBF device from the US Food and Drug Administration (FDA). The device...

    FDA clears Regenity Biosciences’ regenerative meniscus implant

    Regenity Biosciences received FDA 510(k) clearance for its RejuvaKnee implant for soft tissue injuries of the meniscus. The minimally invasive, collagen-meniscal implant aids in...
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