Medical Tubing and Extrusion

Medical tubing and extrusion technologies

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Pulse Biosciences wins FDA IDE to study PFA tech

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Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted an investigational device exemption (IDE) for a pulsed field ablation (PFA) study. The IDE enables the Hayward, California–based company to initiate the NANOPULSE-AF study of its nPulse cardiac catheter ablation system. The study evaluates the company's PFA technology in the … [Read more...] about Pulse Biosciences wins FDA IDE to study PFA tech

ProVerum, Zenflow win FDA nods for BPH treatment devices

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ProVerum and Zenflow this week announced FDA approvals for their technologies that treat benign prostatic hyperplasia (BPH). Dublin, Ireland-based ProVerum won approval for its ProVee system. Zenflow got the green light for its Spring implant and delivery system. Both companies aim to offer a potential treatment for BPH, a common urological … [Read more...] about ProVerum, Zenflow win FDA nods for BPH treatment devices

Atraverse wins FDA clearance for left heart access device

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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

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

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

Jupiter Endovascular wins FDA clearance for Vertex catheter

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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

Pulnovo earns duo of FDA IDE nods for hypertension treatment

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Pulnovo Medical announced today that it received two FDA investigational device exemption (IDE) approvals for its technology. Shanghai-based Pulnovo won IDEs for its pulmonary artery denervation (PADN) catheter and generator. It can now evaluate its technology in studies for Group I and Group II pulmonary hypertension (PH) patients. With full CMS … [Read more...] about Pulnovo earns duo of FDA IDE nods for hypertension treatment

Johnson & Johnson wins FDA nod for intravesical drug delivery tech

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Johnson & Johnson (NYSE:JNJ) announced today that the FDA approved Inlexzo, its gemcitabine intravesical drug delivery system. The intravesical gemcitabine-releasing system, previously known as TAR-200, treats patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in … [Read more...] about Johnson & Johnson wins FDA nod for intravesical drug delivery tech