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    FDA approves early feasibility study of Valcare’s transcatheter device

    The US Food and Drug Administration (FDA) has granted approval for Valcare Medical’s investigational device exemption application, allowing it to begin an early feasibility...

    FDA clears Caristo’s AI-powered CAD diagnostic software

    The US Food and Drug Administration (FDA) has granted clearance to Caristo Diagnostics for CaRi-Plaque, an AI-assisted software application that diagnoses coronary artery disease...

    FDA approves GT Metabolic Solutions’ 50mm magnet in MagDI System

    GT Metabolic Solutions’ use of a 50mm magnet in the MagDI System has received clearance from the US Food and Drug Administration (FDA), supporting...

    FDA clears Miach Orthopaedics ACL implant for expanded use

    The US Food and Drug Administration (FDA) has cleared Miach Orthopaedics Bridge-Enhanced ACL Restoration (BEAR) implant for expanded use in treating complete and partial...

    Ronovo Surgical wins regulatory nod for laparoscopic surgical robot in China

    Ronovo Surgical has received regulatory approval for its Carina surgical robotic platform in China. Shanghai-based Ronovo develops broad, cross-specialty robotic-assisted surgery (RAS) technology. It...

    Cerus secures CE mark approval for LED-based illumination device

    Cerus Corporation has obtained CE mark approval for its INT200, a light-emitting diode (LED)-based illumination device, for the Intercept Blood System for platelets and...

    Phantom Neuro’s neural interface wins FDA breakthrough and TAP designations

    Phantom Neuro today announced it received FDA breakthrough device designation and Targeted Acceleration Pathway (TAP) designation for its minimally invasive neural interface Phantom X. The...

    Penderia Technologies secures FDA Breakthrough Device Designation for Sensorized Soft Tissue Anchor System

    Penderia Technologies, a company developing wireless sensor technologies for orthopedic applications and in collaboration with MRC Global, LLC, recently received the FDA’s Breakthrough Device...

    ABANZA wins FDA clearance for WasherCap Mini fixation device

    ABANZA, a leader in advanced soft tissue repair solutions, shared the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its innovative...

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