Atraverse Medical announced today that it received FDA clearance for its fully integrated Hotwire transseptal access system. Hotwire is a novel radiofrequency guidewire left-heart access device. It enables zero exchange left-heart access while acting as a rail for catheter-based therapy systems. Steven Mickelsen, a pioneer in the pulsed field … [Read more...] about Atraverse wins FDA clearance for left heart access device
510(k)
InterVene wins FDA 510(k) for Recana thrombectomy catheter
InterVene announced today that it received FDA 510(k) clearance for its Recana thrombectomy catheter system. FDA clearance covers the treatment of venous in-stent restenosis (ISR) and native vessel obstructions. It comes just over a year after the company raised $13 million in its Series A funding round to support Recana. Redwood City, … [Read more...] about InterVene wins FDA 510(k) for Recana thrombectomy catheter
Terumo enters U.S. imaging market with FDA nod for dual-sensor system
Terumo Interventional Systems announced today that it received FDA 510(k) clearance for its OpusWave dual-sensor imaging system. OpusWave features the DualView imaging catheter, which received FDA 510(k) clearance alongside the entire system. The platform combines optical frequency domain imaging (OFDI) and intravascular ultrasound (IVUS). It aims … [Read more...] about Terumo enters U.S. imaging market with FDA nod for dual-sensor system
Outlook Surgical wins FDA clearance for hybrid endoscope system
Outlook Surgical this week announced it received FDA 510(k) clearance for its Inova 1 Towerless Endoscope System. The Bloomington, Illinois-based company designed the device to combine the features of a rigid and flexible scope into a single platform. It is intended for head and neck procedures, including ENT and related specialties. Outlook … [Read more...] about Outlook Surgical wins FDA clearance for hybrid endoscope system
Zenflow gets FDA nod for single-use cystoscope
Zenflow announced today that it received FDA 510(k) clearance for its Spring scope and camera control unit (CCU). The South San Francisco, California-based company touts its Spring scope and CCU as the first single-use cystoscope of its kind. It features a 12-fr working channel, making it more than 80% larger than current single-use models, the … [Read more...] about Zenflow gets FDA nod for single-use cystoscope
AngioSafe emerges from stealth with FDA clearance for Santreva-ATK catheter
AngioSafe announced it has received FDA 510(k) clearance and CE marking for its Santreva-ATK endovascular revascularization catheter. San Jose, California–based AngioSafe designed the device for wire-free intraluminal crossing of chronic total occlusions (CTOs) while simultaneously compressing plaque and recanalizing vessels. Santreva-ATK enables … [Read more...] about AngioSafe emerges from stealth with FDA clearance for Santreva-ATK catheter
Jupiter Endovascular wins FDA clearance for Vertex catheter
Jupiter Endovascular announced today that its Vertex catheter received FDA 510(k) clearance for the insertion of endovascular devices. According to the FDA 510(k) database, the agency received Jupiter Endovascular's submission on June 30. It delivered the clearance on Sept. 12. The company took to LinkedIn to announce the regulatory … [Read more...] about Jupiter Endovascular wins FDA clearance for Vertex catheter
Kardium gets FDA green light for Globe pulsed field ablation system
Kardium announced today that the FDA granted premarket approval (PMA) for its Globe pulsed field ablation (PFA) system. Along with the PMA, the FDA granted 510(k) clearance for the Globe introducer sheath and Globe pulsed field mapping software. With the FDA nod, Kardium joins the hot U.S. PFA market that includes major medtech names like … [Read more...] about Kardium gets FDA green light for Globe pulsed field ablation system
FDA clears Imperative Care Symphony thrombectomy system for pulmonary embolism
Imperative Care announced today that the FDA granted 510(k) clearance for its Symphony thrombectomy system to treat pulmonary embolism (PE). The clearance expands the use of Symphony, which previously served as a treatment for venous thrombosis, to PE. It delivers a comprehensive solution for treating the full spectrum of venous thromboembolism … [Read more...] about FDA clears Imperative Care Symphony thrombectomy system for pulmonary embolism
EvoEndo earns expanded FDA clearance for gastroscope
EvoEndo announced today that it received expanded FDA clearance for its Model LE gastroscope, covering patients of all ages. Denver-based EvoEndo's offering now covers neonates to adults, expanding the previous indication for patients aged five and older. The company says its system has been the only option available for sedation-free transnasal … [Read more...] about EvoEndo earns expanded FDA clearance for gastroscope
