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    Regulatory Approvals

    Momentum scores FDA clearance for remote monitoring scoliosis app

    Canadian company Momentum Health has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Momentum Spine app for remote monitoring...

    CALCIVIS® to Launch Revolutionary New Bioluminescent Dental Imaging System in the US After Securing Final Stage Food and Drug Administration Pre-Market Approval

    Calcivis is launching its groundbreaking new preventive dental technology in the United States. The business filed a PMA supplement with the FDA for enhancements...

    Wandercraft secures expanded FDA approval for Atalante X exoskeleton

    France-based medical robotic solutions provider Wandercraft has received expanded US Food and Drug Administration (FDA) approval for Atalante X, its self-balancing robotic exoskeleton. Atalante X...

    neuro42 Receives FDA Clearance on Portable and Compact Brain MRI Scanner for Point of Care Imaging

    neuro42, a medical technology Company leading the innovation of MRI and robotics for brain related diagnosis and treatment, today announced it has received 510(k)...

    Bone Solutions gets expanded FDA nod for Mg OSTEOCRETE in intervertebral procedures

    Orthobiologics technology company Bone Solutions has received the US Food and Drug Administration (FDA) 510(k) clearance for an expanded indication of Mg OSTEOCRETE in...

    Zynex Receives FDA Clearance for its Next Generation NMES Device

    Zynex, an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, today...

    FDA clears Tyber Medical’s Tibia Plating System

    Tyber Medical, a provider of private-label orthopaedic implants, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Proximal Tibia...

    Mainstay secures FDA approval for MRI labelling on ReActiv8 System

    Mainstay Medical has received the US Food and Drug Administration (FDA) approval for full-body MRI conditional labelling for its ReActiv8 Restorative Neurostimulation system. ReActiv8 is...

    ProCell secures CE-marked approval for blood recovery unit

    ProCell Surgical has received CE-marked approval for its Sponge Blood Recovery Unit, allowing it to enter the European Union market. The certification indicates that ProCell’s...
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