The FDA today issued an early notice after Boston Scientific (NYSE:BSX) recommended the removal of certain percutaneous catheter systems. In a letter dated July 9, 2026, Boston Scientific told customers to identify affected EnRoute transcarotid neuroprotection system (NPS) and EnRoute NPS Plus products and cease use and distribution. Customers … [Read more...] about FDA warns on percutaneous catheter issue from Boston Scientific
Catheters
Boston Scientific enrolls first patient in FARADIGM IDE trial for Faraflex PFA system
A Boston Scientific (NYSE:BSX) executive said today that the company enrolled the first patients in a new pulsed field ablation (PFA) trial. Nick Spadea-Anello, Boston Scientific EVP and president of Electrophysiology, shared the news of the initial enrollments on LinkedIn. Dr. Andrea Natale and the Texas Cardiac Arrhythmia Research team at St. … [Read more...] about Boston Scientific enrolls first patient in FARADIGM IDE trial for Faraflex PFA system
Baxter warns on intravascular administration sets
The FDA issued an early alert after Baxter (NYSE:BAX) recommended the removal of certain Duo-Vent intravascular administration sets. Baxter sent all affected customers a letter on June 30, telling them to immediately identify, quarantine and return affected lots. The communication affects lots DR26C27062, DR26D14031 and DR26E13055 of the … [Read more...] about Baxter warns on intravascular administration sets
Imperative Care launches new guidewire purpose-built for stroke
Imperative Care announced that it launched the Ikon 24 Pro guidewire, a next-generation neurovascular device for treating stroke. Campbell, California-based Imperative Care purpose-built the guidewire to improve vascular access during stroke procedures. It says it engineered the Ikon 24 Pro to incorporate three core capabilities. First, the … [Read more...] about Imperative Care launches new guidewire purpose-built for stroke
RapidPulse raises $48M for thrombectomy tech as Medtronic invests
RapidPulse announced today that it closed a $48 million Series B financing, with Medtronic among the investors participating. Miami-based RapidPulse develops next-generation aspiration technology for treating acute ischemic stroke. Its latest funding adds to $10.5 million raised in 2022. Medtronic co-led the funding round alongside TechWald … [Read more...] about RapidPulse raises $48M for thrombectomy tech as Medtronic invests
Medtronic warns on Harmony transcatheter pulmonary valve delivery system
Medtronic (NYSE:MDT) has issued a letter to affected customers recommending the removal of certain lots of its Harmony delivery catheter system (DCS). In a notice published by the FDA, the agency said Medtronic's recall involves removing certain devices from where they are used or sold. The FDA identified it as the most serious type, as it could … [Read more...] about Medtronic warns on Harmony transcatheter pulmonary valve delivery system
Johnson & Johnson wins FDA approval for ThermoCool SmartTouch dual-energy ablation system
Johnson & Johnson (NYSE:JNJ) announced today that it received FDA approval for its dual-energy ThermoCool SmartTouch SF platform (DE STSF). The ThermoCool SmartTouch platform combines the ThermoCool SmartTouch SF catheter with the TruPulse generator. Combining the irrigated contact-force-sensing catheter with TruPulse enables the delivery of … [Read more...] about Johnson & Johnson wins FDA approval for ThermoCool SmartTouch dual-energy ablation system
Xeltis has first commercial implant of vascular access device for hemodialysis
Xeltis announced today that it began European commercialization efforts for its aXess vascular access device. Dr. Dominik Liebetrau at Artemed Klinikum Munich South, Germany, completed the first successful commercial treatment with aXess. aXess, the company’s restorative vascular access conduit, is designed to enable the creation of a new, … [Read more...] about Xeltis has first commercial implant of vascular access device for hemodialysis
Penumbra enrolls first patient in distal acute stroke thrombectomy study
Penumbra (NYSE:PEN) announced today that it initiated the FORWARD study of its mechanical thrombectomy technology. Alameda, California–based Penumbra's real-world, prospective, multi-center study will collect safety and efficacy data on mechanical thrombectomy. That includes computer-assisted vacuum thrombectomy (CAVT) and modulated aspiration … [Read more...] about Penumbra enrolls first patient in distal acute stroke thrombectomy study
Endogenex completes enrollment in trial of endoscopic diabetes treatment
Endogenex announced today that it completed enrollment in the ReCET clinical study of its endoscopic diabetes treatment. ReCET enrolled 350 patients across approximately 40 clinical sites in the U.S. and Australia. It evaluates the safety and effectiveness of the Endogenex System in adult patients with T2D whose blood glucose levels are … [Read more...] about Endogenex completes enrollment in trial of endoscopic diabetes treatment
