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    Regulatory Approvals

    Implantica prepares for FDA approval of acid reflux device

    Implantica has started the premarket approval process with the US Food and Drug Administration (FDA) for its gastroesophageal reflux disease (GERD) treatment, RefluxStop. The Liechtenstein-based...

    FDA clears sleep monitoring software from Beacon Biosignals

    Beacon Biosignals announced that it received FDA 510(k) clearance for its SleepStageML machine-learning software for sleep monitoring.SleepStageML automatically stages sleep from electroencephalogram (EEG) signals...

    SyntheticMR wins FDA 510(k) clearance for 3D brain scanner

    SyntheticMR announced today that its next-generation 3D imaging solution with isotropic resolution received FDA 510(k) clearance.Linköping, Sweden-based SyntheticMR said in a news release that...

    Endostart bags FDA 510(k) clearance for its magnetic colonoscopy device

    Italian medical device company Endostart has secured US Food and Drug Administration (FDA) 510(k) clearance for its colonoscopy device, which is designed to optimise...

    Avicenna.AI wins two FDA clearances for AI tools in CT scans

    The US Food and Drug Administration (FDA) has granted clearance to two of Avicenna.AI’s tools that use AI to assist in pulmonary embolism and...

    FDA clears redesigned kidney stone treatment tech from Calyxo

    Calyxo announced today that it received FDA clearance for its new, redesigned CVAC system for minimally invasive kidney stone treatment.Pleasanton, California–based Calyxo’s CVAC system...

    FDA clears Neuronetics’ neurostim for adolescents with depression

    Neuronetics announced that it received FDA clearance for the use of its NeuroStar therapy for adolescent patients. Clearance covers the use of NeuroStar as...

    Health Canada approves Innodem Neurosciences’s Eye-Tracking Neurological Assessment for Multiple Sclerosis

    Health Canada has granted approval of the Eye-Tracking Neurological Assessment for Multiple Sclerosis (ETNA™-MS). Developed by Innodem Neurosciences (Innodem), ETNA™-MS is a software as...

    RedDrop Dx wins FDA approval for RedDrop One blood collection device

    US-based medical equipment manufacturer RedDrop Dx has received the US Food and Drug Administration (FDA) 510(k) approval for its advanced blood collection device, RedDrop...
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