The FDA issued a notice alerting customers to updates made by Boston Scientific to its PolarX cryoablation catheters. This recall involves updating instructions for use (IFU), not removing devices from the market. The FDA identified it as the most serious type of recall, though, as it may cause serious injury or death. Boston Scientific … [Read more...] about Boston Scientific updates instructions for cryoablation catheters after reported deaths
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FDA approves IDE for Akura Medical’s thrombectomy system
Akura Medical, a Shifamed portfolio company, announced today that the FDA granted its Katana system investigational device exemption (IDE). IDE means Akura can begin the QUADRA-PE study evaluating the thrombectomy system in patients with acute pulmonary embolism (PE). Dr. Sanjum Sethi (Columbia University Medical Center) and Dr. Ann Gage … [Read more...] about FDA approves IDE for Akura Medical’s thrombectomy system
R3 Vascular wins FDA IDE for drug-eluting scaffold
R3 Vascular announced today that the FDA granted investigational device exemption (IDE) to evaluate its Magnitude drug-eluting bioresorbable scaffold. Mountain View, California-based R3 Vascular designed Magnitude for treating below-the-knee (BTK) peripheral arterial disease (PAD). With the FDA granting IDE, it can now initiate the ELITE-BTK … [Read more...] about R3 Vascular wins FDA IDE for drug-eluting scaffold
Vantis Vascular wins FDA nod for integrated microcatheter guide extension system
Vantis Vascular announced today that it received FDA 510(k) clearance for its CrossFast integrated microcatheter guide extension system. San Jose, California-based Vantis develops the CrossFast system along with the CrossShock intravascular lithotripsy (IVL) system. It designed CrossFast to help physicians perform faster, easier and safer … [Read more...] about Vantis Vascular wins FDA nod for integrated microcatheter guide extension system
FDA approves IDE for Medtronic Prevail drug-coated balloon
Medtronic (NYSE: MDT) announced today that it received FDA investigational device exemption (IDE) for its Prevail drug-coated balloon (DCB). The medtech giant can now begin a pivotal clinical trial for the coronary paclitaxel DCB for in-stent restenosis (ISR) and de novo small vessel disease. It plans to use data from its Prevail Global Clinical … [Read more...] about FDA approves IDE for Medtronic Prevail drug-coated balloon
FDA clears Surmodics’ Pounce XL thrombectomy system
Surmodics (Nasdaq:SRDX) announced today that it received FDA 510(k) clearance for its Pounce XL thrombectomy system. The FDA indicated Pounce XL for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 5.5–10 mm in diameter. That makes it suitable for iliac, femoral, and other arteries within this … [Read more...] about FDA clears Surmodics’ Pounce XL thrombectomy system
FDA approves expanded label for Boston Scientific Ingevity+ pacing leads
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] announced today that it received FDA approval to expand the indication for its current-generation Ingevity+ pacing leads. The expanded indication includes conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA) when the pacing leads — thin wires placed … [Read more...] about FDA approves expanded label for Boston Scientific Ingevity+ pacing leads
Olympus’ Odin Medical wins FDA nod for first cloud-based AI endoscopy system for colonoscopy
Olympus announced today that its Odin Medical unit received FDA 510(k) clearance for its Caddie computer-aided detection (CADe) device. The cloud-based AI technology assists gastroenterologists in detecting suspected colorectal polyps during colonoscopy procedures. Olympus says its the first cloud-based AI technology for this purpose. It could … [Read more...] about Olympus’ Odin Medical wins FDA nod for first cloud-based AI endoscopy system for colonoscopy
FDA grants IDE for Jupiter Endovascular’s pulmonary embolectomy system
Jupiter Endovascular announced today that the FDA approved an investigational device exemption (IDE) study for its Vertex system. The company can now conduct the SPIRARE II U.S. pivotal study for the pulmonary embolectomy system. Menlo Park, California-based Jupiter Endovascular only just came out of stealth mode, spinning out of Neptune Medical … [Read more...] about FDA grants IDE for Jupiter Endovascular’s pulmonary embolectomy system
Renata Medical wins FDA nod for first-of-its-kind stent for young children
Renata Medical today said the FDA approved its first-of-its-kind Minima growth stent tailored for neonates, infants and young children. Newport Beach, California-based Renata designed the stent to re-expand over the course of the child’s growth period. The company says its approval marks a “groundbreaking advancement” in care for young children … [Read more...] about Renata Medical wins FDA nod for first-of-its-kind stent for young children
