Balt announced that it received CE Mark approval for its Silk Vista flow diverting stent for treating patients with unruptured intracranial aneurysms. Montmorency, France.-based Balt designed its Silk Vista device for predictable and accurate deployment and high visibility under angiography, adding to its already-CE-Marked Silk Vista baby flow diverter, which has been approved in Europe […]
Medtronic Linq II insertable cardiac monitor gets OK in U.S., Europe
Medtronic (NYSE:MDT) announced today that its Linq II insertable cardiac monitor has received FDA clearance in the U.S., as well as a CE Mark in the EU. The Linq II boasts remote programming. That means a person with the Linq II implanted inside of them doesn’t need to return to the doctor’s office or hospital to […]
Staar Surgical launches presbyopia correcting lens
Staar Surgical (NSDQ:STAA) announced today that it received CE Mark approval for its EVO Viva presbyiopia-correcting implantable Collamer lens (ICL). Lake Forest, Calif.-based Staar Surgical is launching the EVO Viva through select doctors in Spain, Germany and Belgium, initially, with broader availability set to follow across Europe and other markets recognizing the CE Mark, according to […]
Eurofins launches 10-minute COVID-19 exposure testing device
Eurofins (Paris:ERF.PA) announced today that it launched its rapid point-of-care testing devices to identify past exposure to COVID-19. The serology-based, finger-prick tests detect antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms, with results coming in just 10 minutes, according to a news release. Eurofins’ CE-Marked INgezim dual-recognition immunochromatographic assays […]
Kardium lands CE Mark for mapping and ablation device
Kardium announced that it received CE Mark approval in Europe for its Globe mapping and ablation system for treating atrial fibrillation (AF). Vancouver, B.C.-based Kardium’s spherical Globe catheter is comprised of 122 electrodes to provide electrophysiologists with single-shot pulmonary vein isolation, high-definition mapping and atrial ablation, according to a news release. Approval in Europe came […]
Akili wins CE mark for digital ADHD treatment
Akili Interactive announced today that it received CE Mark approval for its EndeavorRx video game for children with attention deficit hyperactivity disorder (ADHD). Boston-based Akili’s prescription treatment is delivered through a video game experience as a way to improve attention function as measured by computer-based testing in children between ages 8 and 12 with primarily inattentive […]
Medtronic wins CE mark for TAVI system in low-risk patients
Medtronic (NYSE:MDT) announced today that it received CE Mark approval for its Evolut transcatheter aortic valve implantation (TAVI) system. Evolut TAVI, now commercially launched in Europe, is now indicated for patients with severe native aortic stenosis who are at a low risk of surgical mortality. The system’s indications in Europe now cover all risk categories for […]
Beckman Coulter wins CE Mark for COVID-19 antibody test
Beckman Coulter announced this week that its Access SARS-CoV-2 IgG antibody assay received CE Mark approval and is commercially available in Europe. Brea, Calif.-based Beckman Coulter said in a news release that it already shipped tests to more than 400 hospitals, clinics and diagnostic laboratories in the U.S. and has begun to ship around the […]
Sirius Medical wins CE mark for non-radioactive localization system
Sirius Medical announced that it received CE Mark approval for its Sirius Pintuition non-radioactive tumor localization system. Eindhoven, the Netherlands-based Sirius said in a news release that it intends to launch the Pintuition system in September of this year, with the first systems currently in production. The company intends to implement the systems in hospitals […]
Smith & Nephew Regeneten bioinductive implant wins CE mark
Smith & Nephew (NYSE:SNN) announced today that its Regeneten bioinductive implant for rotator cuff procedures received CE Mark approval in Europe. Regeneten, a collagen-based implant, supports the body’s natural healing process by inducing the growth of new tendon-like tissue to biologically augment the existing tendon and disrupt disease progression. The implant, which is the size of […]
Medtronic lands CE Mark for Micra AV transcatheter pacing system
Medtronic (NYSE:MDT) announced today that it received CE Mark approval in Europe for its Micra AV transcatheter pacing system (TPS). The Fridley, Minn.-based medtech giant touts its Micra AV as the world’s smallest pacemaker with atrioventricular (AV) synchrony. The system is indicated for treating patients with AV block, adding to its CE Mark-approved leadless pacemaker portfolio. […]
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