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    Regulatory Approvals

    Kelyniam and Finceramica announce FDA clearance for NEOS system

    Kelyniam Global and Finceramica Faenza have announced the Food and Drug Administration (FDA) 510(k) clearance for the NEOS Surgery Cranial LOOP fixation system to...

    FDA authorises Prenosis’ AI-based tool for sepsis diagnosis

    The US Food and Drug Administration (FDA) has granted marketing authorisation for Prenosis’ AI tool Sepsis ImmunoScore, to diagnose sepsis. This authorisation, achieved through the...

    FDA clears Affinity Biosensors’s LifeScale AST diagnostic platform

    The US Food and Drug Administration (FDA) has granted clearance for Affinity Biosensors’s LifeScale AST system, a diagnostic tool for rapid antibiotic susceptibility testing...

    WAT Medical wins FDA nod for OTC migraine preventative device

    WAT Medical this week won FDA clearance for over-the-counter use of its HeadaTerm 2 wearable anti-migraine device. HeadaTerm 2 uses neuromodulation technology. It releases targeted...

    Coreline Soft win FDA 510(k) clearance for AI-powered coronary artery calcification analysis solution

    Coreline Soft said its artificial intelligence (AI)-powered coronary artery calcification automatic diagnostic solution, AVIEW CAC, has received 510(k) clearance from the U.S. FDA. A 510(k)...

    Tandem Mobi automated insulin pump wins FDA nod for expanded pediatric use

    Tandem Diabetes Care (Nasdaq:TNDM) announced that the FDA cleared its Mobi insulin pump for an expanded pediatric indication.The FDA approved Tandem’s 510(k) application for...

    Fractyl Health receives IDE approval for Revita trial

    US-based biotech Fractyl Health has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to conduct a clinical trial...

    FDA clears Eko Health’s AI for heart failure detection

    Eko Health announced today that the FDA cleared its Low EF (ejection fraction) detection AI platform for its digital stethoscope.Using an Eko stethoscope, providers...

    Baird receives Class III certificate for thyroid treatment needle

    Baird Medical has received new Class III certificate for its ceramic thyroid ablation needle from China’s National Medical Products Administration (NMPA). The certificate recognises the...
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