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    Kallisio’s 3D printed oral stent gains US FDA clearance for cancer

    Kallisio has received US Food and Drug Administration (FDA) 510(k) clearance for its 3D-printed oral stent solution, Stentra, designed for precise radiation therapy for...

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

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

    AnX Robotica secures expanded FDA approval for NaviCam SB endoscope

    AnX Robotica has received the US Food and Drug Administration (FDA) approval for expanded indications of its NaviCam Small Bowel (SB) video capsule endoscopy...

    IMVARIA bags FDA authorisation for AI lung fibrosis diagnostic  

    The US Food and Drug Administration (FDA) has given the green light to US-based IMVARIA for its lead product Fibresolve, an artificial intelligence (AI)-based...

    Sensydia completes study for AI-driven Cardiac Assessment Platform

    Sensydia has announced the completion of a pivotal study of the Cardiac Performance System (CPS) involving 50 subjects, marking a significant step towards the...

    Capitainer secures three US patents

    “These patents reinforce our strategic position, facilitating Capitainer’s expansion in the US market. The recognition from the United States Patent Office is a testament...

    HistoSonics treats first kidney tumour patient in Edison System trial

    Medical device company HistoSonics has treated the first kidney tumour patient in the #HOPE4KIDNEY trial of its breakthrough Edison Histotripsy System. The Edison System is...

    Picodya diagnostics system adopted through NIH pandemic initiative

    Israel-based in vitro diagnostics (IVD) firm, Picodya, has announced that its B-Matrix multiplexed point-of-care testing (xPOCT) systems are being implemented in government laboratories across...

    EndoQuest and Omnivision partner for surgical robotic visualisation system

    US-based medical device company EndoQuest Robotics and Omnivision have joined forces to incorporate image sensor technology into surgical robotics.   Omnivision will integrate its OCHFA CameraCubeChip...

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