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    Regulatory Approvals

    Ligence Heart receives FDA 510(k) clearance

    Ligence announces that its AI-powered echocardiography software, Ligence Heart, has received U.S. Food and Drug Administration (FDA) 510(k) clearance. Ligence Heart, is an AI-powered...

    iCardio.ai wins second FDA 510(k) clearance for CardioVision

    iCardio.ai announces FDA 510(k) Clearance for CardioVision. This is the company’s second FDA clearance. CardioVision can automatically detect aortic stenosis, a disease affecting 1.5M Americans...

    CeriBell gets FDA nod for the Clarity neonate seizure detection algorithm

    CeriBell announced that it received FDA 510(k) clearance for its next-generation Clarity algorithm. The new algorithm detects electrographic seizures in newborns pre-term and older. Clearance...

    QuantalX gains de novo classification for neuro-imaging system

    QuantalX Neuroscience’s Delphi-MD, a device to monitor and evaluate brain health, has gained de novo classification from the US Food and Drug Administration (FDA),...

    Paradromics gets FDA approval for early feasibility study of Connexus BCI

    Paradromics received FDA investigational device exemption (IDE) to begin a study of its brain-computer interface (BCI). The FDA nod enables the company to start...

    EDAP wins FDA nod for its Focal One robotic high-intensity focused ultrasound system

    EDAP TMS SA announced that the FDA granted 510(k) clearance for new workflows for its ultrasound technology. The new ultrasound imaging and workflow enhancements...

    Neurolyser XR now FDA cleared for sale in USA

    FUSMobile announced that it received De Novo marketing authorization (DEN250015) from the FDA to begin marketing and sales of the Neurolyser XR system for...

    FDA clears Levita’s Magnetic Surgical System for pediatric use

    Levita Magnetics has received FDA 510(k) clearance for its Magnetic Surgical System (MSS) to be used in certain pediatric surgeries, with the first U.S....

    Zimmer Biomet secures FDA approval for ROSA Knee with OptimiZe system

    Zimmer Biomet has received 510(k) clearance from the US Food and Drug Administration (FDA) for ROSA Knee with OptimiZe technology. It is an updated version...
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