Pentax Medical announced today that the FDA cleared its DEC duodenoscope compatibility with the Sterrad 100NX sterilizer. Advanced Sterilization Products (ASP) develops Sterrad as its flagship product. Together, the companies aim to address the ongoing challenges of duodenoscope reprocessing. They hope to reduce the risk of cross-contamination … [Read more...] about Pentax wins FDA nod for duodenoscope with new sterilization tech
510(k)
Teleflex wins FDA clearance for perfusion balloon for PTCA
Teleflex (NYSE: TFX) announced today that the FDA has granted 510(k) clearance for the company's Ringer perfusion balloon catheter for percutaneous transluminal coronary angioplasty (PTCA). The clearance expands Wayne, Pennsylvania–based Teleflex's interventional cardiology portfolio. It enables the company to offer what it says is the only … [Read more...] about Teleflex wins FDA clearance for perfusion balloon for PTCA
Imperative Care wins FDA nod for stroke catheter
Imperative Care announced today that the FDA granted 510(k) clearance for its Zoom 6F insert catheters for ischemic stroke procedures. The company also announced the successful completion of the first case with the Zoom 6F insert catheters. Dr. Dana Tomalty performed the case at Huntsville Hospital in Huntsville, Alabama. Tomalty used the … [Read more...] about Imperative Care wins FDA nod for stroke catheter
Atraverse wins FDA nod for left-heart access device, raises $12.5M
Atraverse Medical announced today that the FDA cleared its Hotwire radiofrequency guidewire left-heart access device. The novel device enables zero exchange left-heart access while acting as a rail for catheter-based therapy systems. Steven Mickelsen, the founder of Farapulse, invented the Hotwire system with co-founder Eric Sauter. It's the … [Read more...] about Atraverse wins FDA nod for left-heart access device, raises $12.5M
FDA clears computer-assisted thrombectomy system from Penumbra
Penumbra (NYSE:PEN) announced today that it received FDA clearance for and began the launch of its Lightning Flash 2.0 CAVT system. Lightning Flash 2.0 represents the next generation of the company's computer-assisted vacuum thrombectomy (CAVT) technology. It removes the venous thrombus to treat pulmonary emboli (PE). The system features … [Read more...] about FDA clears computer-assisted thrombectomy system from Penumbra
The top catheter-based innovation news stories of 2024 — so far
Catheter innovations have had a remarkable year so far, with many receiving regulatory approval as they prepare to enter the market. The pulsed field ablation market heated up in 2023 and continues to make waves this year with more companies entering the space. Intravascular lithotripsy is having its moment as well – Shockwave Medical was … [Read more...] about The top catheter-based innovation news stories of 2024 — so far
