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
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Medtronic earns first-of-its-kind FDA labeling for Endurant stent graft
![The Endurant stent graft system. [Image courtesy of Medtronic]](https://www.medicaltubingandextrusion.com/wp-content/uploads/2025/10/Endurant_Hero_woDS-1-300x195.jpg)
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
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
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
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
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
![The Inlexzo system. [Image courtesy of Johnson & Johnson]](https://www.medicaltubingandextrusion.com/wp-content/uploads/2025/09/Inlexzo-JJ-2-1-300x195.jpg)
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
Pulse Biosciences wins FDA IDE to conduct study of PFA tech for AFib
Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted investigational device exemption (IDE) for its pulsed field ablation (PFA) system. The approval allows Pulse to proceed with the initiation of the NANOCLAMP AF study. NANOCLAMP AF evaluates the company's nanosecond PFA (nsPFA) Cardiac Surgery System for treating AFib. According … [Read more...] about Pulse Biosciences wins FDA IDE to conduct study of PFA tech for AFib
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
Airiver Medical wins FDA IDE for pulmonary drug-coated balloon
Airiver Medical announced today that it received FDA investigational device exemption (IDE) for its pulmonary drug-coated balloon (DCB). The Brooklyn Park, Minnesota-based company designed its DCB to treat central airway stenosis. This FDA IDE – the company's first — allows it to begin a pivotal clinical trial of the technology. Central airway … [Read more...] about Airiver Medical wins FDA IDE for pulmonary drug-coated balloon
