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    Nyxoah Announces Achievement of Key Clinical and Regulatory Milestones 

    Nyxoah Announces Achievement of Key Clinical and Regulatory MilestonesAll 115 patients implanted in DREAM U.S. pivotal studyFirst DREAM PMA module submittedFirst patient implanted in...

    FDA clears surgical robot from Noah Medical

    Noah Medical announced that it received FDA clearance for its Galaxy System for robotic-navigated bronchoscopy. San Carlos, California-based Noah Medical designed Galaxy and its accessories to...

    Theranica receives FDA 510(k) for migraine prevention device

    The company had previously received FDA clearance to use its prescription wearable to treat migraines at onset. Prescription digital therapeutic developer Theranica announced it has received FDA...

    FDA clears Elekta’s radiation therapy automation

    Elekta (Stockholm:EKTA-B) says an FDA 510(k) clearance represents a new era in precision radiation therapy to treat cancer in the U.S. The Sweden-based cancer and...

    RapidAI Enhances Pulmonary Embolism Care Solution with FDA 510(k) Clearance for Rapid RV/LV

    RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, announced it has received FDA 510(k) clearance for Rapid...

    FDA authorizes marketing of Medasense’s NOL® (nociception level index) technology through a De Novo grant

    Medasense Biometrics Ltd. announced that  the U.S. Food and Drug Administration (FDA) has granted marketing authorization to the PMD-200 patient monitor with NOL® technology developed...

    Origami Surgical wins FDA clearance for StitchKit device for robotic surgery

    Origami Surgical announced that it received FDA clearance for the insertion and removal of its StitchKit device. Madison, New Jersey-based Origami’s new FDA indication allows for...

    Medtronic Receives CE Mark for Extravascular Defibrillator System That Treats Abnormal Heart Rhythms

    Medtronic plc (NYSE:MDT) has received CE (Conformité Européenne) Mark for the Aurora EV-ICD™ MRI SureScan™ (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV™ MRI SureScan™ defibrillation...

    Lumendi Receives 510(k) Clearance for Two New Devices

    Connecticut-based medical device innovator Lumendi, LLC announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable...

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