More
    Guided Solutions - Connecting Talent With Innovation/div>

    Ra Medical Systems Receives FDA 510(k) Clearance for the DABRA 2.0 Catheter

    Ra Medical Systems, Inc. (NYSE American: RMED)(“Ra Medical” or the “Company”), a medical device company focusing on developing its excimer laser system to treat...

    ResApp gets 510(k) clearance for mobile sleep apnoea test SleepCheck

    It has been approved as a prescription-only software-as-a-medical device in the US. ASX-listed ResApp Health has received the US Food and Drug Administration's 510(k) clearance...

    LiveMetric secures FDA 510(k) clearance for LiveOne BP monitoring system

    LiveOne combines MEMS nanosensors with AI algorithms to provide BP measurement. LiveMetric has received 510(k) clearance from the US Food and Drug Administration (FDA) for LiveOne, a...

    Radiobotics’ fracture support diagnostic CE-marked under MDR

    Radiobotics’ RBfracture has been CE-marked under MDR (European Medical Device Regulations) as a class IIa medical device, positioning the Danish healthtech company among some of the first...

    US FDA grants expanded 510K clearance for MolecuLight’s i:X imaging device

    MolecuLight i:X allows visualisation of regions containing bacterial species at the point-of-care. The US Food and Drug Administration (FDA) has granted expanded 510(K) clearance for MolecuLight’s i:X...

    US FDA approves Beyond Air LungFit PH to treat hypoxic respiratory failure

    LungFit PH uses ambient air to generate unlimited, on-demand nitric oxide to treat hypoxic respiratory failure in neonates. The US Food and Drug Administration (FDA)...

    Acutus Medical Announces FDA Clearance, Commercial Launch of AcQCross™ Line Extension Compatible with Watchman™ Delivery System

    Innovative Transseptal Access System Is First and Only to Feature Integrated Dilator and Needle to Reduce Exchanges Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia...

    Envoy Medical Receives FDA IDE Approval to Begin Early Feasibility Study of Acclaim® Cochlear Implant

    Envoy Medical® Corporation, a hearing health company focused on providing innovative technologies across the hearing loss spectrum, announced the U.S. Food and Drug Administration...

    FDA grants breakthrough nod for Carthera’s SonoCloud-9

    Carthera announced that it received FDA breakthrough device designation for its SonoCloud-9 system. Paris-based Carthera designed SonoCloud-9 for implantation in a skull window below the skin....

    Latest articles