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    Regulatory Approvals

    FDA approves Happy Health’s medical-grade wearable smart ring

    Health technology company Happy Health has received approval from the US Food and Drug Administration (FDA) for its Happy Ring, a clinical-grade wearable smart...

    Corin wins FDA nod for Unity Knee tibial insert for robot-assisted TKA

    Corin received FDA 510(k) clearance for its Unity Knee medial constrained (MC) tibial insert. Cirencester, UK-based Corin designed the Unity Knee MC tibial insert...

    FDA greenlights OrthAlign’s handheld Lantern Hip navigation system

    OrthAlign has expanded its portfolio of Lantern handheld navigation systems by securing a 510(k) clearance from the US Food and Drug Administration (FDA) for...

    Positrigo announces CE mark for NeuroLF PET system

    Zurich-based nuclear medical imaging device firm Positrigo’s positron emission tomography (PET) system, NeuroLF, has acquired market authorisation from the European Union (EU). The ultra-compact diagnostic...

    FDA approves BioIntelliSense’s BioButton wearable for patient monitoring

    BioIntelliSense has received approval from the US Food and Drug Administration (FDA) for its BioButton Multi-Patient wearable and BioDashboard system for continuous patient monitoring. The...

    US FDA clears Elucid’s PlaqueIQ imaging analysis software

    PlaqueIQ is a non-invasive software that can objectively quantify and classify plaque morphology based on ground-truth histology, and is designed to give physicians new,...

    FDA clears Surmodics’ Pounce XL thrombectomy system

    Surmodics received FDA 510(k) clearance for its Pounce XL thrombectomy system. The FDA indicated Pounce XL for the non-surgical removal of thrombi and emboli...

    Pi-Cardia wins FDA nod for leaflet modification device that enables TAVR

    Pi-Cardia announced the FDA granted clearance for its ShortCut leaflet modification device for TAVR procedures. Rehovot, Israel-based Pi-Cardia designed ShortCut to split the leaflets...

    Human in Motion Robotics secures Canadian approval for XoMotion exoskeleton

    Robotic mobility and humanoid technology company Human in Motion Robotics has received regulatory approval to market and sell the XoMotion exoskeleton in Canada. It is...
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