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 […]
CE Mark
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 […]
Praxis Medical wins CE mark for CytoCore soft tissue biopsy device
Praxis Medical announced that it received CE mark approval for its CytoCore soft tissue biopsy device. Tampa, Fla.-based Praxis said in a March 8 news release that the approval for CytoCore allows the country to expand its technology into European Union member countries and offer fine-needle biopsies on a global scale. CytoCore is designed to […]
This vocal biomarker software can screen for COVID-19
Startup Vocalis Health today announced that its artificial intelligence-aided screening tool, VocalisCheck, screening tool, VocalisCheck, has obtained a CE mark for screening for COVID-19. VocalisCheck is designed as a screening tool that can deliver a reliable risk score to guide people who may need diagnostic testing for the coronavirus. A smartphone or other device using […]
Roche obtains CE Mark for rapid COVID-19 test with easier nose collection
Roche (SWX: RO, ROG) announced today that it received CE Mark approval for its new SARS-CoV-2 nasal rapid antigen test. Basel, Switzerland-based Roche’s nasal test collects the sample from the front area of the nose instead of the nasopharynx, which is the method used with its existing SARS-CoV-2 rapid antigen test. The new method results in a simplified […]
Abbott Panbio rapid antigen test wins CE mark for asymptomatic COVID-19 screening
Abbott (NYSE:ABT) announced today that it received CE Mark for two new uses of its Panbio COVID-19 Ag rapid diagnostic. Panbio COVID-19 Ag has received an updated label with clinical data on asymptomatic individuals to enable mass testing of people who do not currently present symptoms of the disease, according to a news release. The other […]
TransEnterix receives CE Mark for AI for its robotic surgery system
TransEnterix (NYSE:TRXC) announced today that it received CE Mark approval for its Intelligent Surgical Unit for the Senhance system. The Intelligent Surgical Unit (ISU) enables machine vision capabilities on the Senhance surgical system, providing Senhance digital laparoscopic programs in Europe augmented intelligence capabilities in surgical settings, according to a news release. The FDA cleared the ISU […]
Distalmotion gains CE Mark for surgical robot
Distalmotion announced that it received CE Mark approval for its Dexter surgical robot for minimally invasive surgical care. Lausanne, Switzerland-based Distalmotion said in a news release that its Dexter system combines the affordability of laparoscopy with the benefits of robotic surgery to increase simplicity and versatility in the space. Distalmotion said Dexter is ready for […]
Abbott secures CE Mark for test that helps measure immune repsonse to COVID-19
Abbott (NYSE:ABT) announced today that it received CE Mark approval for its new SARS-CoV-2 IgG lab-based serology test. The Abbott Park, Ill.-based company’s IgG antibody test for the virus causing COVID-19 offers a quantitative result to help evaluate a person’s immune response to a vaccine, according to a news release. Abbott’s quantitative IgG antibody test detects […]
Cardio-Phoenix secures CE Mark for AI-powered heart diagnostic
Cardio-Phoenix recently announced that it received CE Mark approval for its Cardio-Heart heart disease diagnostic device. European approval came in October for the “Chart” system which combines a device for capturing the heart’s physiological bio-signals with a cloud-based, AI-powered diagnostic analysis engine, according to a news release. Cardio-Phoenix said the system is designed to ensure […]
Abbott launches next-gen 3D cardiac mapping platform in Europe, Australia
Abbott (NYSE:ABT) announced today that it received CE Mark and Australian approval for its new EnSite X EP system. EnSite X EP is touted as the only system that allows for navigation of the cardiac anatomy in two different ways through the same lone platform. The new cardiac mapping platform builds upon Abbott’s electrophysiology portfolio with […]
