Medical Tubing and Extrusion

Medical tubing and extrusion technologies

Regulatory

InterVene wins FDA 510(k) for Recana thrombectomy catheter

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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

CMS finalizes renal denervation coverage that benefits Medtronic, Recor

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CMS today issued its final National Coverage Determination (NCD) on renal denervation (RDN), marking a major win for Medtronic [WtwhTicker symbol="MDT"](NYSE: MDT)[/WtwhTicker] and Recor Medical. Both companies develop their own RDN systems. Recor Medical received the first FDA nod for its Paradise ultrasound RDN (uRDN) system in November 2023. … [Read more...] about CMS finalizes renal denervation coverage that benefits Medtronic, Recor

Terumo enters U.S. imaging market with FDA nod for dual-sensor system

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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

Medtronic earns first-of-its-kind FDA labeling for Endurant stent graft

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Medtronic (NYSE: MDT) announced today that it received new labeling approval from the FDA for its Endurant stent graft system. The new labeling adds ruptured abdominal aortic aneurysm (rAAA) clinical evidence and removes the rAAA treatment warning. This makes Medtronic the first and only company to remove the rAAA warning from stent graft … [Read more...] about Medtronic earns first-of-its-kind FDA labeling for Endurant stent graft

Abbott gets FDA breakthrough nod for dual-energy ablation catheter

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An Abbott [WtwhTicker symbol="ABT"](NYSE: ABT)[/WtwhTicker] official posted on social media to announce FDA breakthrough device designation for a new ablation catheter. Abbott SVP Uri Yaron said on LinkedIn that the FDA granted the breakthrough nod for the TactiFlex Duo Sensor-Enabled catheter. The catheter features a dual-energy modality for the … [Read more...] about Abbott gets FDA breakthrough nod for dual-energy ablation catheter

Outlook Surgical wins FDA clearance for hybrid endoscope system

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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

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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

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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

Olympus issues voluntary recall for certain endoscope needles

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Olympus announced a voluntary, global medical device removal of certain ViziShot 2 FLEX (19G) EBUS -TBNA (ViziShot 2 FLEX) needles. The company manufactured affected needles prior to May 12, 2025. It initiated the recall after receiving reports of device components detaching during procedures. Olympus said that it assessed the issue after … [Read more...] about Olympus issues voluntary recall for certain endoscope needles

Abbott updates instructions for TactiFlex ablation catheter following instances of tip damage

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The FDA today issued a notice warning of updated instructions for the Abbott (NYSE: ABT) TactiFlex Ablation Catheter, Sensor-Enabled (SE). According to the agency, Abbott issued a letter to affected customers recommending updated instructions when removing the catheter from its packaging. The communication comes as part of the FDA's Communications … [Read more...] about Abbott updates instructions for TactiFlex ablation catheter following instances of tip damage