Biomerics recently announced that it is doubling its manufacturing footprint in Costa Rica and Texas. The Salt Lake City, Utah-based company broke ground on a new greenfield plant adjacent to its current operations in the La Zeta Free Trade Zone in Cartago, Costa Rica. The new facility totals 110,000 sq. ft and will include engineering labs, … [Read more...] about Biomerics expands Costa Rica, Texas manufacturing operations
Catheters
Medtronic launches DCB for dialysis patients in Japan
Medtronic (NYSE:MDT) this week said it launched its first drug-coated balloon in Japan for patients undergoing hemodialysis. The company launched its In.Pact AV drug-coated balloon, which is indicated for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae in patients with end-stage renal … [Read more...] about Medtronic launches DCB for dialysis patients in Japan
MedAlliance nabs FDA breakthrough nod for drug-eluting coronary balloon
MedAlliance today said it received FDA breakthrough device designation for its Selution SLR sustained limus release drug-eluting balloon catheter. Selution SLR is designed to treat atherosclerotic lesions in native coronary arteries. The breakthrough designation was awarded for its design of improving luminal diameter in patients with … [Read more...] about MedAlliance nabs FDA breakthrough nod for drug-eluting coronary balloon
LeMaitre Vascular grows 25% in Q4
LeMaitre Vascular yesterday posted fourth-quarter results that beat the consensus forecast on Wall Street. The Burlington, Mass.-based company report profits of $7 million, or 34¢ per share, on sales of $37.5 million for the three months ended Dec. 31, 2020, for a bottom-line gain of 52.5% on sales growth of 24.5% compared with Q4 … [Read more...] about LeMaitre Vascular grows 25% in Q4
The worst catheter-based device recalls of 2020
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
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