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    Regulatory Approvals

    Cercare Medical secures FDA clearance for CT Perfusion Imaging software

    Cercare Medical announced FDA clearance for its CT perfusion imaging software, a significant milestone that complements the existing clearance for MRI perfusion imaging. This...

    Liquet Medical receives FDA 510(k) clearance for the Versus catheter

    Liquet Medical Inc., a pioneering medical device company committed to advancing patient care through innovative technologies, today announced it has received 510(k) clearance from...

    FemPulse wins FDA IDE for for overactive bladder neuromod

    FemPulse received FDA investigational device exemption (IDE) approval for its overactive bladder (OAB) therapy. The company can now begin the EVANESCE II pivotal clinical trial...

    SyntheticMR wins FDA nod for SyMRI 15 imaging solution

    SyntheticMR, a developer of quantitative imaging software, has gained FDA 510(k) clearance for its SyMRI 15 solution on diagnostic image replacement of conventional images. SyMRI...

    Vision RT wins CE Mark certifications for DoseRT, MapRT and Respiratory Module

    Vision RT announced CE mark certifications for three innovative products: MapRT ®, DoseRT® and the AlignRT Respiratory Module. DoseRT is a treatment verification tool that...

    Lungpacer Medical wins FDA premarket approval for AeroPace neurostim system

    Lungpacer Medical announced it received FDA premarket approval for its flagship AeroPace neurostimulation system. AeroPace uses neurostimulation via an electrode-containing cardiovascular catheter and a...

    Field Medical wins FDA breakthrough designation for pulsed field ablation system

    US-based Field Medical has secured breakthrough device designation from the US Food and Drug Administration (FDA) for the FieldForce ablation system. FieldForce is the first...

    MatOrtho’s ReCerf® Hip Resurfacing Arthroplasty wins regulatory approval

    MatOrtho, the UK-based global innovator of hip and knee replacement devices, shared the ReCerf® Hip Resurfacing Arthroplasty has become the world's first all-ceramic hip...

    FDA clears Movano smart ring’s pulse oximetry feature

    Movano Health announced it received FDA 510(k) clearance for the pulse oximeter in its EvieMED Ring. Clearance enables Movano to pursue new opportunities for...
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