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    Regulatory Approvals

    China-based Surgerii Robotics wins CE mark for single-port surgical robot

    Surgerii Robotics announced on LinkedIn that its Shurui single-port surgical robot garnered CE mark approval in Europe. According to the company’s post, it marks the...

    FDA grants 510(k) clearance to 4DMedical’s CT:VQ for respiratory diagnostics

    The US Food and Drug Administration (FDA) has granted 510(k) clearance to 4DMedical’s non-contrast, computed tomography (CT)-based ventilation-perfusion imaging technology, CT:VQ, for respiratory diagnostics. This...

    Airiver Medical wins FDA IDE for pulmonary drug-coated balloon

    Airiver Medical announced it received FDA investigational device exemption (IDE) for its pulmonary drug-coated balloon (DCB). The Brooklyn Park, Minnesota-based company designed its DCB to...

    Ciliatech wins CE mark for an eye implant for treating glaucoma

    Ciliatech announced it received CE mark approval for its Intercil uveal spacer, an eye implant for treating glaucoma. The Chavanod, France-based company labeled Intercil as...

    Brightonix wins FDA nod for flagship PET imaging system

    Brightonix Imaging announced its flagship Pharos positron emission tomography (PET) scanner received FDA clearance. Pharos, a state-of-the-art clinical PET system, offers high-quality imaging as part...

    NeuroOne’s nerve ablation system secures FDA clearance

    NeuroOne Medical Technologies has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its OneRF trigeminal nerve ablation system to treat...

    Onward wins FDA IDE for ARC-IM spinal cord stimulation system

    Onward Medical announced it received FDA investigational device exemption (IDE) for its ARC-IM system. ARC-IM, an implanted neuromodulation platform, delivers targeted and personalized spinal cord...

    SpinaFX’s Triojection system wins FDA breakthrough device designation

    The FDA has granted breakthrough device designation to SpinaFX Medical’s Triojection system, a minimally invasive treatment for contained lumbar disc herniations. Triojection is an image-guided...

    DeepSight receives first FDA clearance for NeedleVue LC1 Ultrasound System

    DeepSight Technology announced it received FDA 510(k) clearance for its NeedleVue LC1 ultrasound system. The company said clearance marks an important step forward in the...
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