Thermo Fisher Scientific (NYSE:TMO) announced that it received CE Mark approval in Europe for the use of its diagnostic test in detecting nucleic acid from the SARS-CoV-2 virus that causes COVID-19. The Waltham, Mass.-based company’s test uses Applied Biosystems’ TaqPath assay and real-time PCR technology. It is designed to provide results within four hours of a […]
FDA to authorize certain imported respirators for healthcare worker use
The FDA said yesterday that certain imported respirators (FFRs) may be eligible for emergency use authorization (EUA) to protect public health and safety during the coronavirus outbreak. The FDA said these these devices, imported from Australia, Brazil, Europe, Japan, Korea and Mexico, may be effective in protecting healthcare workers from airborne COVID-19 particulates, “based on […]
DePuy Synthes wins CE Mark for hip replacement dual mobility system
Johnson & Johnson’s (NYSE:JNJ) DePuy Synthes announced that it won CE Mark approval for its Bi-Mentum dual mobility system for people with a higher risk of dislocation. Bi-Mentum is designed with a standard femoral head articulating within a large polyethylene liner that swivels within a metal shell, reducing the risk of dislocation, which can impact patient satisfaction […]
Dianosic lands CE Mark for intranasal bleeding device
Startup Dianosic (Strasbourg, France) announced today that it has obtained the CE Mark for CAVI-T, a low-pressure asymmetric balloon for treating spontaneous and post-operative intranasal bleeding. CAVI-T is the first asymmetric intranasal balloon that stops bleeding by applying low-force compression while adapting to the anatomy of the nasal fossa, according to the company. The balloon […]
LivaNova lands CE Mark for depression neurostimulation treatment
LivaNova (NSDQ:LIVN) said today that its vagus nerve stimulation therapy for treatment-resistant depression has won the CE Mark in Europe. Two patients in the United Kingdom were implanted with the company’s Symmetry system at the Musgrove Park Hospital in Taunton, England, making them the first patients to receive Symmetry devices outside the United States. The ability […]
Abbott wins CE Mark for FlexNav delivery system
Abbott (NYSE:ABT) announced today that it won CE Mark approval in Europe for the FlexNav delivery system for its Portico transcatheter aortic valve implantation (TAVI) system. The Abbott Park, Ill.-based company’s FlexNav delivery system is designed to offer another tool for doctors to treat patients requiring a transcatheter aortic valve implant by incorporating stability, predictability and […]
V-Wave lands CE Mark for heart-failure device
V-Wave announced today that its Ventura interatrial shunt system has received the CE Mark. The Caesarea, Israel-based company’s minimally invasive, implanted interatrial shunt is being evaluated in a global, randomized, controlled, double-blinded, 500-patient pivotal IDE trial called RELIEVE-HF. The study is enrolling advanced heart failure patients with preserved or reduced left ventricular ejection fraction who […]
Neovasc to seek CE Mark for Tiara transapical mitral valve repair device
Neovasc (NSDQ:NVCN) announced that it plans to win CE Mark approval for its TA Tiara under the new European Medical Device Regulation (EU MDR) by 2021 or earlier. The company said it has treated 82 patients to date with the transapical (TA) Tiara mitral valve repair device. After reviewing the clinical data from its Tiara I […]
CryoLife wins CE Mark for ascending aortic prosthesis
CryoLife Inc. (NYSE:CRY) announced that it received CE Mark approval for the On-X ascending aortic prosthesis (AAP) for treating native or prosthetic heart valves in the aortic position involving an ascending aortic aneurysm. The approval allows for resumed distribution of the On-X AAP in Europe, as the product has been off the market there since late […]
Ibex wins CE Mark for AI-powered cancer detection software
Ibex Medical Analytics announced today that it won CE Mark approval for its artificial intelligence-powered Galen Prostate software for identifying suspected cancer on prostate core needle biopsies. Tel Aviv-based Ibex touts its Galen prostate solution as the first-ever AI-based software for cancer detection used in routine clinical practice, and it is already deployed in pathology […]
Fist Assist announces CE Mark and European launch
Fist Assist Devices recently announced that it received CE Mark approval for its Fist Assist device for vein enhancement and enlargement. Los Altos Hills, Calif.-based Fist Assist Devices said it has begun commercialization and marketing of the device in the European Union. The Fist Assist device is a non-invasive external platform designed to utilize a […]
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