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    Regulatory Approvals

    Eko picks up reimbursement win for AI heart disease detection platform

    Eko Health announced the American Medical Association issued a Category III CPT code for its Sensora platform. The newly issued CPT code goes into...

    Xeltis wins FDA breakthrough status, enrols first patient in pivotal trial

    Dutch company Xeltis shared that the US Food and Drug Administration (FDA) granted breakthrough device designation to its lead product, called aXess, which will...

    Magstim earns FDA clearance for transcranial magnetic stimulation that treats depression, OCD

    Magstim announced that the FDA cleared its next-generation Horizon Inspire system for delivering transcranial magnetic stimulation (TMS). Clearance paves the way for the use...

    Momentis Surgical wins FDA nod for second-gen surgical robot

    Momentis Surgical announced the FDA granted 510(k) clearance for its second-generation Anovo surgical robot. Last month, Anovo received clearance for use in single-site, abdominal...

    Limaca’s Precision-GI™ granted CMS Transitional Pass-Through payment

    The Centers for Medicare & Medicaid Services has granted transitional pass-through payment for Limaca Medical's Precision-GI™ motorised endoscopic biopsy device. Limaca's endoscopic device is...

    FDA clears SimBioSys clinical decision support tech for breast cancer surgery

    SimBioSys received its second FDA 510(k) clearance for TumorSight Viz to expand its use by breast surgeons in the U.S. Chicago-based SimBioSys picked up an...

    Corin wins FDA clearance for new femoral stem

    Corin received FDA 510(k) clearance for its Icona femoral stem implant for total hip arthroplasty (THA). This clearance comes just one month after Corin...

    SYNDEO Medical Announces European MDR Approval for Two Product Brands

    SYNDEO Medical, a Belgium-based leader in diagnostic and interventional procedural solutions, announces that its two flagship product brands, SYNDEOPack Interventional Procedure Packs™ and Xssential...

    Zeta Surgical wins FDA nod for AI-powered surgical nav tech

    Zeta Surgical announced the FDA granted 510(k) clearance for its Zeta Navigation System for expanded capabilities. The clearance applies to use with expanded instruments...
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