Scientia Vascular announced today the successful completion of a $14 million growth financing round. West Valley City, Utah–based Scientia says the money will enable it to continue commercializing what company officials describe as the next generation of neurovascular tools, providing new ways to treat a variety of neurovascular disease … [Read more...] about Scientia Vascular raises $14M for neurovascular treatment tech
About Chris Newmarker
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
InnovHeart has first in-human implantation of its TMVR
InnovHeart (Newton, Massachusetts and Milan) announced the first trans-septal clinical trial implant of its proprietary Saturn transcatheter mitral valve. According to the company, there were excellent hemodynamic results for the patient — a 79-year-old woman suffering from severe mixed (degenerative and functional) mitral regurgitation. The … [Read more...] about InnovHeart has first in-human implantation of its TMVR
Stereotaxis to acquire Access Point Technologies and its EP catheters
Stereotaxis (NYSE: STXS) is purchasing a Minneapolis-based electrophysiology (EP) catheter maker to further enhance its minimally invasive endovascular surgical robotics technology. St. Louis–based Stereotaxis did not disclose how much it is paying for Access Point Technologies in its after-hours news release. The transaction, paid with … [Read more...] about Stereotaxis to acquire Access Point Technologies and its EP catheters
Medtronic pulsed field ablation system wins approval in Japan
Medtronic (NYSE: MDT) announced today that its PulseSelect pulsed field ablation (PFA) system has won regulatory approval in Japan. The regulatory nod in Japan further expands the reach of the system, which in December became the first PFA system approved in the United States to treat paroxysmal and persistent atrial fibrillation (AFib). Since … [Read more...] about Medtronic pulsed field ablation system wins approval in Japan
Boston Scientific has a serious recall involving embolization tech
The FDA announced today that it has designated a Boston Scientific recall of its Obsidio conformable embolic as Class I, its most serious level of recall. The Obsidio embolic is a premixed embolic agent that is delivered in a minimally invasive way through a catheter-based system. The embolic can block or occlude blood flow to specific blood … [Read more...] about Boston Scientific has a serious recall involving embolization tech
How Abbott created its next-gen RF ablation system
For Abbott, combining two innovations into one AFib-treating system required manufacturing fine-tuning. The project’s R&D director explains. Pulsed field ablation (PFA) has generated a great deal of buzz for its potential to reduce complications in procedures for treating atrial fibrillation (AFib). But even as Abbott is developing its Volt … [Read more...] about How Abbott created its next-gen RF ablation system
Medtronic has a serious catheter tubing recall
The FDA today designated a Medtronic recall of Duet external drainage and monitoring system catheter tubing as Class I, its most serious level. Medtronic Neurosurgery initiated the recall on Jan. 22. According to the FDA, it involves 45,176 devices distributed from May 3, 2021, to Jan. 9, 2024. The model numbers involved are 46913, 46914, 46915, … [Read more...] about Medtronic has a serious catheter tubing recall
ICU Medical’s Smiths Medical has a major syringe pump recall
The FDA this week said it's designated an ICU Medical and Smiths Medical recall of Medfusion syringe pumps as Class I, the agency's most serious level of medical device recall. The recall involves more than 50,000 Medfusion Model 4000 syringe infusion pumps in the U.S. that were distributed from Nov. 16, 2010, to July 28, 2023. The Medfusion … [Read more...] about ICU Medical’s Smiths Medical has a major syringe pump recall
FastWave Medical kicks off first-in-human study of its IVL tech
FastWave Medical announced the successful completion of enrollment for its first-in-human study of its peripheral intravascular lithotripsy (IVL) system to treat calcified cardiovascular disease. Dr. Miguel Montero-Baker of Houston Methodist Hospital and the Hope Vascular & Podiatry Clinic and Dr. Venkatesh Ramaiah of HonorHealth Vascular … [Read more...] about FastWave Medical kicks off first-in-human study of its IVL tech
