The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA. The agency 2020 tagged a total of 33 medical device recalls as Class I — the most serious level — down from 49 in 2019. The list of the most serious catheter-based device recalls in 2020 includes products from … [Read more...] about The worst catheter-based device recalls of 2020
Acutus Medical names new chief financial officer
Acutus Medical (Nasdaq: AFIB) today announced that it appointed David Roman as its CFO, effective March 1. Founded in 2011, Carlsbad, Calif.–based Acutus Medical boasts a portfolio of electrophysiology products that includes catheter-based treatments for cardiac arrhythmias. Roman has more than 15 years of experience in the medical technology … [Read more...] about Acutus Medical names new chief financial officer
FDA panel votes against BD Lutonix drug-coated balloon for below-the-knee
An FDA advisory panel voted against a favorable recommendation for BD's Lutonix catheter-based, drug-coated balloon for use below the knee. The FDA's Circulatory System Devices Advisory Panel yesterday voted 15-to-2 in favor of the issue of safety when Lutonix is used as intended and voted 15-to-2 against the issue of a reasonable assurance of … [Read more...] about FDA panel votes against BD Lutonix drug-coated balloon for below-the-knee
Front Line Medical wins Health Canada approval for arterial occlusion system
Front Line Medical Technologies yesterday said it received Health Canada approval for its COBRA-OS arterial occlusion system. The COBRA-OS (Control of Bleeding, Resuscitation, Arterial Occlusion System) is designed to be extremely low-profile for temporary hemorrhage control and resuscitation. “Even with all the advances in medicine today, … [Read more...] about Front Line Medical wins Health Canada approval for arterial occlusion system
Smart Medical Systems launches G-Eye colonoscope in U.S.
Smart Medical Systems this week announced that it received additional FDA clearance for its G-Eye Colonoscope. The G-Eye Colonoscope includes a balloon at the distal bending section that moderately inflates during colonoscopies to assist in controlling the colonoscope's field of view and positioning. In published clinical studies, G-Eye … [Read more...] about Smart Medical Systems launches G-Eye colonoscope in U.S.
Cardiovascular Systems, Chansu Vascular Technologies partner to develop drug-coated balloons
Cardiovascular Systems recently announced that it has partnered with Chansu Vascular Technologies to develop a new drug-coated balloon technology. Through the partnership, Cardiovascular Systems and Chansu Vascular Technologies will develop peripheral and coronary everolimus drug-coated balloons. Cardiovascular Systems will provide … [Read more...] about Cardiovascular Systems, Chansu Vascular Technologies partner to develop drug-coated balloons
Smart urinary catheter company moves to Minneapolis, changes its name to UroDev
UroDev Medical, formerly known as Spinal Singularity, this week announced it appointed Matt Monarski as CEO and that it would be moving its headquarters to Minneapolis. Monarski joins the company with nearly 30 years of global commercial experience focused on advancing new urology, gynecology and orthopedic medical devices. Prior to joining the … [Read more...] about Smart urinary catheter company moves to Minneapolis, changes its name to UroDev
FDA: Penumbra recall of some Jet 7 catheters is serious
A Penumbra recall of certain Jet 7 catheters is Class I – the most serious type of recall, the FDA recently said. The recall, which Penumbra originally announced on Dec. 15, 2020, involved more than 30,000 distributed units of its Jet 7 Reperfusion Catheters with Xtra Flex Technology after the company received 14 reports of death related to the … [Read more...] about FDA: Penumbra recall of some Jet 7 catheters is serious
Medtronic touts recently acquired Rist catheters for neurovascular procedures
Medtronic today announced an early, site-limited release of its recently acquired Rist radial access guide catheters. The Rist 079 catheter is designed for the introduction of interventional devices into the peripheral, coronary and neuro vasculature using the radial artery in the wrist. The Rist radial access selective catheter is designed to … [Read more...] about Medtronic touts recently acquired Rist catheters for neurovascular procedures
Ancora Heart says enrollment has started for AccuCinch pivotal trial
Ancora Heart this week said it has enrolled the first patient in its AccuCinch Ventricular Restoration System pivotal trial. AccuCinch is a flexible implant that is attached to the inner wall of the left ventricle and then cinched. It is designed to reduce the size of the left ventricle, reduce ventricular wall stress and support and strengthen … [Read more...] about Ancora Heart says enrollment has started for AccuCinch pivotal trial