Karl Storz announced that it received FDA clearance for the FIVE S 6.5 sterile single-use bronchoscope. The company says its new device offers a valuable new option for critical care physicians, intensivists, RTs and ICU-based proceduralists. It delivers an airway control solution for high-risk patients, especially those managing heavy … [Read more...] about Karl Storz wins FDA nod for single-use bronchoscope
510(k)
Olympus picks up pediatric indications from FDA for duo of single-use bronchoscopes
Olympus announced today that it received FDA clearance for pediatric use for two of the single-use bronchoscopes it distributes in the U.S. Center Valley, Pennsylvania-based Olympus Corp. of the Americas distributes the H-SteriScope single-use video flexible bronchoscopes in the U.S. Hunan Vathin Medical Instrument Co. manufactures the scopes. … [Read more...] about Olympus picks up pediatric indications from FDA for duo of single-use bronchoscopes
Imricor wins FDA clearance for MRI-guided EP mapping catheter
Minneapolis-based Imricor Medical Systems (ASX:IMR) said it won 510(k) clearance from the FDA for its Vision-MR Diagnostic Catheter. The 9 Fr catheter is designed for use under real-time magnetic resonance imaging (MRI) guidance for the treatment of heart conditions. The device allows electrophysiologists to visualize cardiac soft tissue with … [Read more...] about Imricor wins FDA clearance for MRI-guided EP mapping catheter
Francis Medical wins FDA nod for water vapor ablation system
Francis Medical has received FDA clearance for its Vanquish water vapor ablation system for prostate tissue ablation. Maple Grove, Minnesota–based Francis Medical, a privately-held company, announced the 510(k) clearance on Dec. 2, describing it as a critical milestone that enables the commercial launch of the system as a prostate cancer treatment … [Read more...] about Francis Medical wins FDA nod for water vapor ablation system
Atraverse wins FDA clearance for left heart access device
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
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
