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

    Regulatory Approvals
    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 by its credit card size and cable-free design, is claimed...

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

    Regulatory Approvals
    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

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

    Fluid Biomed raises $27m to advance ReSolv brain aneurysm stent

    Funding
    Fluid Biomed has completed a $27m Series A equity financing round to advance the development of its stent for treating brain aneurysms. The Canada-based company...

    ENEA-Tech Biomedical foundation invests €6m in BetaGlue Therapeutics

    Funding
    BetaGlue® Therapeutics S.p.A. (“BetaGlue”) an Italian clinical-stage oncology company developing an innovative radiotherapy platform for the targeted and personalised treatment of unresectable solid tumours,...

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    Finance

    Funding

    Clinical Trials

    SamanTree Medical’s Histolog scanner shows promise in breast surgery outcomes

    SamanTree Medical has revealed that its Histolog scanner, a confocal laser microscope, significantly decreased breast-conserving surgery (BCS) reoperation rates by 67% as observed in...

    Protaryx Medical completes first-in-human trial of transseptal puncture device

    US-based Protaryx Medical has completed a first-in-human trial of its transseptal puncture (TSP) device. The company’s trial enrolled five patients, with the TSP procedure carried...

    EndoQuest wins FDA IDE to study surgical robot in colorectal surgery

    EndoQuest Robotics announced it received FDA investigational device exemption (IDE) for a study of its surgical robot. The IDE allows the Houston, Texas-based company...

    ShiraTronics initiates FDA IDE study for implantable neuromod

    ShiraTronics announced it initiated its FDA investigational device exemption (IDE) pivotal trial for its neuromodulation therapy. The RELIEV-CM2 clinical study evaluates the company’s neuromodulation...
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    Innovation

    Regulatory Approvals

    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...

    Fluid Biomed raises $27m to advance ReSolv brain aneurysm stent

    Fluid Biomed has completed a $27m Series A equity financing round to advance the development of its stent for treating brain aneurysms. The Canada-based company...

    ENEA-Tech Biomedical foundation invests €6m in BetaGlue Therapeutics

    BetaGlue® Therapeutics S.p.A. (“BetaGlue”) an Italian clinical-stage oncology company developing an innovative radiotherapy platform for the targeted and personalised treatment of unresectable solid tumours,...

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