More
    Guided Solutions - Connecting Talent With Innovation/div>

    Regulatory Approvals

    FDA approves breast reconstruction trial using human ADM

    The US Food and Drug Administration (FDA) has approved MTF Biologics’s trial using the FlexHD Pliable device in breast reconstruction after the agency granted...

    Medtronic receives FDA approval for extravascular defibrillator to treat abnormal heart rhythms, sudden cardiac arrest

    DUBLIN, Oct. 23, 2023 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, has received U.S. Food and Drug Administration (FDA) approval for the Aurora EV-ICD™...

    FDA Approves Protembis’ Pivotal IDE Study for ProtEmbo CEP System

    AACHEN, Germany--(BUSINESS WIRE)--Protembis GmbH (Protembis) a privately-held emerging cardiovascular medical device company, announced today the FDA has approved the PROTEMBO Pivotal IDE Trial (NCT05873816)....

    Cardio Flow receives US FDA clearance for FreedomFlow platform

    Cardio Flow has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its FreedomFlow Orbital Atherectomy Peripheral Platform. The platform deploys a...

    Praxis Medical Announces FDA Clearance of the EndoCore EBUS-TBNA Biopsy Device

    Praxis Medical announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of the EndoCore EBUS-TBNA fine needle biopsy device. Endobronchial ultrasound with...

    Heidelberg’s ANTERION platform gets US FDA approval

    Ophthalmic imaging company Heidelberg Engineering has secured US Food and Drug Administration (FDA) clearance for its ANTERION platform. ANTERION is an all-in-one upgradeable platform to transform...

    FDA grants 510(k) clearance to Werfen for Aptiva CTD Essential reagent

    Werfen has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Aptiva Connective Tissue Disease (CTD) Essential reagent. A fully automated multi-analyte system,...

    Masimo gets de novo approval from FDA for ORi

    Masimo has received de novo approval from the US Food and Drug Administration (FDA) for ORi, its noninvasive, continuous parameter that delivers additional insight into a patient’s...

    FDA clears Establishment Labs’ magnetic-free breast tissue expander

    The US Food and Drug Administration (FDA) has cleared Establishment Labs’ tissue expander for breast reconstruction surgery. In a statement announcing the news, the US-headquartered company said...
    1...323334...86Page 33 of 86

    Latest articles

    Popular articles

    Featured

    Newsletter

    [hubspot type=form portal=25601863 id=e07d0241-001f-4840-8c08-6e5a4f7af710]

    © Copyright - Guided Solutions - Global Executive Search in Medical Devices