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    The FDA clears Magstim Horizon INSPIRE TMS system

    Magstim won U.S. Food and Drug Administration (FDA) clearance for the Horizon Inspire System, which provides physicians, nurse practitioners, clinicians, and researchers with next-generation...

    FDA grants IDE approval for the pivotal trial of Roivios’ JuxtaFlow® renal assist device

    Roivios, a pioneering clinical-stage medical device company dedicated to revolutionising kidney health, announced its research and development arm, 3ive Labs, has secured approval for...

    Onward wins FDA De Novo classification for non-invasive spinal cord stimulation system

    Onward Medical received FDA de novo clearance for its ARC-EX spinal cord stimulation (SCS) system. ARC-EX SCS therapy delivers targeted, programmed electrical stimulation transcutaneously...

    HeartBeam’s arrhythmia assessment system gains FDA 510(k) clearance

    HeartBeam has gained the US Food and Drug Administration’s 510(k) clearance for its comprehensive arrhythmia assessment system. The patented high-fidelity electrocardiogram (ECG) HeartBeam device, distinguished...

    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...

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