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    Regulatory Approvals

    InVera Medical wins European approval for vein infusion device

    InVera Medical announced recently that it picked up European approval for its minimally invasive device for delivering vein treatments. The Galway, Ireland-based company designed its...

    Medtronic wins FDA nod for surgical robot for spine procedures

    Medtronic announced that it received FDA clearance for its Stealth AXiS robotic system for spine surgery. Stealth AXiS brings planning, navigation and robotics together...

    ZOLL achieves EU MDR approval for Zenix device

    Asahi Kasei’s ZOLL has received approval for its Zenix monitor/defibrillator under the European Union Medical Device Regulation 2017/745 (EU MDR). The device is designed...

    Vesalio earns CE marks for vasospasm, thrombectomy treatments

    Vesalio expanded its neurovascular portfolio after earning CE mark certification for two new devices: NeVa VS and Neva 3.0 mm. The first of Vesalio’s...

    Sonorous Neurovascular earns FDA breakthrough mark for novel stent

    Sonorous Neurovascular received FDA breakthrough device designation for its BosSTENT device intended to treat pulsatile tinnitus, the company announced. “The BosSTENT represents years of focused...

    Median Technologies receives FDA 510(k) clearance for eyonis LCS, an AI-based detection and diagnosis device for lung cancer screening

    Median Technologies, developer of eyonis, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a...

    Eyas Medical Imaging wins FDA 510(k) clearance for the Ascent3T neonatal magnetic resonance imaging system

    Eyas Medical Imaging received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Ascent3T Neonatal Magnetic Resonance Imaging (MRI) System, a whole-body magnetic...

    FDA clears RevealDX’s AI lung nodule diagnostic

    RevealDX has obtained US Food and Drug Administration (FDA) clearance for RevealAI-Lung, an artificial intelligence (AI)-based software for lung nodule risk assessment. The Washington-based company’s...

    Aidoc secures FDA clearance for healthcare’s first comprehensive foundation model AI

    Aidoc, the pioneer and global leader of clinical AI, announced that the U.S. Food and Drug Administration (FDA) has cleared the healthcare industry’s first...
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