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    Medical Microinstruments signs multiple distro deals, wins regulatory nods

    Medical Microinstruments announced it hit significant commercial milestones for its surgical robot across two continents. The company develops the Symani surgical robot system, which...

    FDA clears Orthofix Fitbone transport and lengthening system

    Orthofix received FDA 510(k) clearance for the Fitbone Transport and Lengthening System and reported the first implant of the device. The Lewisville, Texas–based company...

    Pulse Biosciences wins FDA breakthrough nod for AFib-treating pulsed field ablation tech

    Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted breakthrough device designation for its pulsed field ablation system. Shares of PLSE rose more than...

    Avicenna.AI secures EU-MDR certification for five AI tools

    Medical imaging company Avicenna.AI has secured Medical Device Regulation (MDR) certification for five of its AI algorithms which are used to screen severe conditions. Avicenna.AI’s...

    Signum Surgical’s BioHealx technology obtains FDA clearance

    Signum Surgical has secured De Novo clearance from the US Food and Drug Administration (FDA) for its BioHealx technology for anal fistula treatment. BioHealx is...

    FDA brings Paradromics BCI into advisory program

    Brain-computer interface (BCI) developer Paradromics announced today that the FDA accepted it into its Total Product Life Cycle Advisory Program (TAP). TAP provides early...

    FDA issues 510(k) approval for Epica’s See Factor CT3 system

    Epica International has announced an updated 510(k) clearance from the US Food and Drug Administration (FDA) for its See Factor CT3 System. This clearance signifies...

    FDA clears IceCure Medical’s next-gen single-probe cryoablation system

    IceCure Medical announced the FDA granted clearance for its next-generation single-probe cryoablation system. The XSense cryoablation system with CryoProbes received clearance for all indications...

    CeQur wins FDA nod for mealtime insulin delivery device

    CeQur announced recently that the FDA granted 510(k) clearance for its Simplicity system for an extended wear duration. Clearance extends the wear time for...

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