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    FDA Clears AIOMEGA’s AIO Breathe, for Treatment of Obstructive Sleep Apnea

    AIOMEGA, a Texas biomedical company, announced that AIO BREATHE, their medical device that treats Obstructive Sleep Apnea, has been cleared by the Food and...

    New Soldier® High Flow Microcatheter Granted FDA Clearance

    Embolx Inc., a leading medical technology company developing microcatheters for arterial embolization procedures, is thrilled to announce that the U.S. Food and Drug Administration...

    Spectral AI’s DeepView software secures UKCA authorisation

    Spectral AI has received UK Conformity Assessed (UKCA) authorisation for its DeepView AI-Burn predictive software. The authorisation allows the system to aid in burn wound...

    Virtual Incision secures FDA authorisation for MIRA Surgical System

    Virtual Incision has received the US Food and Drug Administration (FDA) marketing authorisation of the MIRA Surgical System (MIRA) for colectomy procedures in adults. MIRA...

    SeaStar’s device granted humanitarian exemption approval for children with AKI

    Following positive clinical results, the US Food Drug Administration (FDA) has granted SeaStar Medical a humanitarian device exemption (HDE) approval for its Quelimmune selective...

    IMRIS, Deerfield Imaging Receives FDA Clearance for the InVision 1.5 Surgical Theatre

    IMRIS, Deerfield Imaging, the global leader in intraoperative imaging, announced that the company has received 510(k) clearance from the U.S. Food and Drug Administration...

    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...

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