Regulatory Approvals

FDA accepts Sibel Health’s Aria sensor for COA qualification

Sibel Health has received acceptance from the US Food and Drug Administration (FDA) into the clinical outcome assessment (COA) qualification programme under the drug...

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...
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