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    AliveCor gains US FDA clearance for KardiaMobile 6L to calculate patients’ QTc interval

    AliveCor has today announced the receipt of 510(k) clearance from the US Food and Drug Administration (FDA) for healthcare professionals to use the KardiaMobile...

    Quidel Receives CE Mark for Savanna® Multiplex Molecular Analyzer and Respiratory Viral Panel

    New Savanna® platform can analyze up to 12 pathogens, plus controls, from a single sample Savanna® RVP4 Assay targets influenza A+B, RSV and COVID-19 Quidel Corporation...

    Natural Cycles receives FDA clearance for birth control wearable

    Natural Cycles, the first FDA cleared birth control app, has received new FDA clearance to revise its labelling and expand the types of third-party...

    Siemens Healthineers Announces FDA Clearance of MAGNETOM Free.Max 80 cm MR Scanner

    Siemens Healthineers Announces FDA Clearance of MAGNETOM Free.Max 80 cm MR Scanner Company’s smallest, most lightweight scanner uses less than 1 liter of helium and...

    NuVasive receives CE Mark for Pulse platform and begins global clinical evaluations

    NuVasive has revealed that its Pulse platform received CE Mark approval for its latest design update and clinical evaluations are now underway in multiple...

    Interventional Systems receives FDA clearance for its all-around miniature medical robot

    - MicromateTM, the world's smallest head-to-toe medical robot, was FDA-cleared, making way for the European company to start building its US presence; - The robot,...

    Viz.ai sets its sights across the pond with CE mark for stroke-detecting AI

    With a recent influx of more than $70 million in a series C financing and, now, a shiny new CE mark for its stroke-spotting...

    Via Surgical Receives FDA Clearance for Industry’s First Orthopedic Suture-Based Fixation System

    The TissueTak™* tendon anchor is the first closed-loop suture based fixation for soft tissue to soft tissue repair of certain types of injuries, designed...

    Penumbra Wins FDA Clearance for RED 62 Reperfusion Catheter

    Penumbra, a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance and commercial availability of the...

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