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 […]
CE Mark
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 […]
MMI wins CE Mark for robotic microsurgery system
MMI SpA announced today that it received CE Mark for and launched its Symani surgical system for open microsurgical procedures. Calci, Italy-based MMI’s Symani system also experienced its first human use, having been used in four successful robotic surgeries performed in Florence, Italy. Three of those procedures were complex, post-traumatic lower limb reconstructions, with one […]
BD launches assay for COVID-19 immune assessment in Europe
Becton Dickinson (NYSE:BDX) announced today that it received CE Mark for and launched its immune assessment product for COVID-19 patients. The BD Multitest 6-color TBNK reagent with BD Trucount tubes received the European regulatory approval with expanded clinical application for the identification and enumberation of T-cell subtypes in COVID-19 patients to help inform the clinical course […]
Aferetica, CytoSorbents gain EU nod for organ perfusion system
CytoSorbents (NSDQ:CTSO) and Aferetica today announced the European Union approval of Aferetica’s PerLife integrated ex-vivo system to perfuse, cleanse, recondition and preserve harvested kidneys and livers — including those that are usually discarded. Italian startup Aferetica designed its PerLife system is to improve organ function and viability while reducing the risk of primary graft failure and organ rejection. […]
Boston Scientific launches spinal cord stimulator systems in Europe
Boston Scientific (NYSE:BSX) announced that it launched its WaveWriter Alpha spinal cord stimulator (SCS) system portfolio in Europe. Marlborough, Mass.-based Boston Scientific’s portfolio includes four MRI-conditional, Bluetooth-enabled implantable pulse generators (IPGs) and offers expanded personalization, rechargeable and non-rechargeable options and access to waveforms covering multiple areas of pain, according to a news release. SCS therapies relieve […]
BD wins CE mark for 15-minute COVID-19 diagnostic test
Becton Dickinson (NYSE:BDX) announced today that it received CE Mark approval in Europe for its rapid COVID-19 test. Franklin Lakes, N.J.-based BD’s rapid, point-of-care SARS-CoV-2 antigen test — used on the BD Veritor Plus system — delivers results in 15 minutes on a portable instrument to allow for on-site results and decision making, according to a […]
