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    Regulatory Approvals

    Synaptive Medical’s latest version of Modus Nav receives CE mark

    Synaptive Medical is pleased to announce that its latest Modus Navigation System (Modus Nav) has achieved CE marking under the European Medical Device Regulation...

    Breath Diagnostics receives FDA Breakthrough Device Designation for OneBreath platform

    Breath Diagnostics, a leader in breath-based molecular diagnostics powered by patented microreactor capture technology, is pleased to announce that the U.S. Food and Drug...

    Biomendex receives FDA 510(k) clearance for Adaptos Fuse Bone Graft

    Biomendex announced that Adaptos® Fuse Bone Graft has received U.S. Food and Drug Administration (FDA) 510(k) clearance as a bone graft substitute for filling...

    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...
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