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    Regulatory Approvals

    FDA panel gives go-ahead to Lumicell’s breast cancer detection tool

    A US Food and Drug Administration (FDA) panel has issued a positive recommendation for Lumicell’s surgical imaging tool for breast cancer detection. The FDA’s Medical...

    SurGenTec wins FDA nod for hydrophilic synthetic bone graft

    SurGenTec announced today that it received FDA 510(k) clearance for its OsteoFlo HydroPutty synthetic bone graft.OsteoFlo HydroPutty follows the company’s OsteoFlo NanoPutty, which received...

    RDS granted CE mark for MultiSense remote monitoring wearable

    Stéphanie Hilbold, director of quality assurance and regulatory affairs at RDS, said: “Achieving this pivotal milestone is testament to the hard work of our...

    EDAP obtains FDA breakthrough status for endometriosis device

    EDAP TMS, a developer of invasive medical devices, has received the US Food and Drug Administration’s (FDA) breakthrough device designation for its Focal One...

    Axena secures new HCPCS code for Leva Pelvic Health System

    Axena Health has announced that its Leva Pelvic Health System received a new Healthcare Common Procedure Coding System (HCPCS) Level II code from the...

    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...
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