Cook Medical announced that FDA has granted breakthrough device designation for its Zenith Fenestrated+ endovascular graft (ZFEN+), the next-gen version of its Zenith Fenestrated AAA endovascular graft. The designation — a first for Bloomington, … [Read More...] about Cook Medical wins FDA breakthrough device designation for next-gen endovascular graft
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Medical Tubing & Extrusion
Cook Medical wins FDA breakthrough device designation for next-gen endovascular graft
Cook Medical announced that FDA has granted breakthrough device designation for its Zenith Fenestrated+ endovascular graft (ZFEN+), the next-gen version of its Zenith Fenestrated AAA endovascular graft. The designation — a first for Bloomington, … [Read More...] about Cook Medical wins FDA breakthrough device designation for next-gen endovascular graft
Ambu single-use endoscope wins Frost & Sullivan innovation award
Frost & Sullivan today announced that it awarded Ambu with a 2021 Global New Product Innovation Award. Ambu received the award for its single-use flexible endoscopes that are designed to make the devices safe, affordable and accessible. It has … [Read More...] about Ambu single-use endoscope wins Frost & Sullivan innovation award
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 … [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 … [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 … [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 … [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 … [Read More...] about Front Line Medical wins Health Canada approval for arterial occlusion system
