CooperVision (NYSE:COO) announced today that its DreamLite night contact lenses received CE mark approval for children with myopia. San Ramon, Calif.–based CooperVision designed its DreamLite night lenses to slow the progression of myopia in children with a refraction of -0.75 D to -5.00 D and a cylindrical refraction with a maximum of -2.50 D, according […]
CE Mark
Intersect ENT wins CE mark for Propel Contour sinus implant
Intersect ENT (NSDQ:XENT) announced today that it received CE mark approval for its Propel Contour sinus implant. Menlo Park, Calif.-based Intersect ENT designed its Propel Contour sinus implant to maintain patency and reduce inflammation while conforming to the sinus ostia (openings) through mechanical support and steroid delivery where needed to optimize sinus surgery outcomes. Propel […]
CorVent Medical gains CE mark approval for critical care ventilator
CorVent Medical announced that it received CE mark approval for its Respond-19 ventilator and is preparing to launch it in Europe. Santa Clara, Calif.-based CorVent’s Respond-19 ventilator allows hospitals to treat more patients suffering from acute respiratory distress syndrome (ARDS). The system received FDA emergency use authorization (EUA) for primary critical care use in December […]
Abbott wins CE mark for Navitor TAVI
Abbott (NYSE:ABT) announced today that it received CE mark approval for its Navitor transcatheter aortic valve implantation (TAVI) system. The latest-generation TAVI system from Abbott, Navitor won European approval for treating those with severe aortic stenosis who are at high or extreme surgical risk, according to a news release. Navitor uses Abbott’s FlexNav delivery system […]
Medtronic wins CE mark approval for Evolut Pro+ TAVI system
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its next-generation Evolut Pro+ TAVI system. Fridley, Minn.-based Medtronic’s Evolut Pro+ transcatheter aortic valve implantation (TAVI) system is the newest version of the company’s self-expanding, supra-annular Evolut TAVI platform. It won U.S. FDA approval in 2019. The latest edition of the platform includes four […]
Abbott launches AI-powered coronary imaging platform in Europe
Abbott (NYSE:ABT) announced today that it launched its new coronary imaging platform in Europe as it is now CE marked. The platform, powered by Ultreon 1.0 software, merges optical coherence tomography (OCT) with AI to enhance visualization and detect the severity of calcium-based blockages and measure vessel diameter, according to a news release. The goal […]
J&J Vision wins regulatory nods for phacoemulsification machine
Johnson & Johnson Vision (NYSE:JNJ) announced today that it received FDA 510(k) clearance and CE mark for its Veritas vision system. Santa Ana, Calif.–based Johnson & Johnson Vision’s next-generation Veritas phacoemulsification system is designed to allow surgeons to guide through any lens density with less surge and more stability. It also incorporates advancements in ergonomics […]
OncoSec wins CE mark for electroporation device to treat solid tumors
OncoSec Medical (NSDQ:ONCS) announced today that it received CE mark approval for its next-generation device to enable better uptake of anti-cancer therapies. GenPulse, part of OncoSec’s electroporation device platform for treating solid tumors, is designed to apply short electric impulses to a tumor, according to a news release. The electric impulses cause pores to open […]
Ortho Clinical Diagnostics lands CE mark for high-volume COVID-19 test
Ortho Clinical Diagnostics (NSDQ:OCDX) announced that it received a CE mark for its Vitros SARS-CoV-2 antigen test for COVID-19. European approval follows the Vitros test’s initial launch in October 2020. The CE mark allows for more convenient sample collection and expanded viral transport media, according to a news release. Personnel at hospitals, labs and other […]
Abbott wins CE mark for next-generation TriClip
Abbott (NYSE:ABT) announced today that it received CE mark approval for its next-generation TriClip transcatheter tricuspid valve repair system. The company touts the TriClip as a first-of-its-kind, minimally invasive tricuspid heart valve repair device for treating tricuspid regurgitation (TR), according to a news release. Abbott Park, Ill.–based Abbott’s clip-based therapy is a non-surgical heart valve […]
Abbott Xience stent gains expanded CE mark
Abbott (NYSE:ABT) announced today that its Xience stent received CE mark approval for a shorter duration of dual anti-platelet therapy (DAPT). The European approval for the stent allows for the DAPT to go as short as 28 days, the shortest indication available in the world for patients with high bleeding risk (HBR), according to a news […]