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 […]
CE Mark
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 […]
Surgical Innovation Associates gains CE Mark for absorbable mesh
Surgical Innovation Associates announced this week that it has secured CE Mark approval for its flagship absorbable mesh, DuraSorb. The product is designed to provide mechanical support and scaffolding during the early months of wound healing and scar formation, followed by gradual absorption to leave the patient free of foreign material by one year, according to […]
Abbott’s FreeStyle Libre 3 receives CE Mark
Abbott (NYSE:ABT) has won the CE Mark in the European Union for its next-generation FreeStyle Libre 3 continuous glucose monitoring system. Officials at Abbott boast that the Libre 3 technology includes a super small, thin sensor. It’s the size of two U.S. pennies stacked together and able to accurately provide real-time glucose readings over 14 days […]
Boston Scientific launches aortic valve system in Europe
Boston Scientific (NYSE:BSX) announced today that it began a controlled launch of its Acurate neo2 aortic valve system in Europe. Marlborough, Mass.-based Boston Scientific’s next-generation transcatheter aortic valve implantation (TAVI) technology is designed to improve upon the original version of the Acurate neo platform. Acurate neo2 has expanded indication for patients with aortic stenosis (with no […]
Abbott gains CE Mark for next-gen MitraClip
Abbott (NYSE:ABT) announced today that it received CE Mark approval in Europe for its fourth-generation MitraClip system. MitraClip G4, the latest installment of the Abbot Park, Ill.-based company’s transcatheter mitral valve repair (TMVR) system, is now approved for use in countries recognizing the CE Mark as a non-surgical option for treating mitral regurgitation (MR) or a […]
Abbott launches glucose biosensor for athletes in Europe
Abbott (NYSE:ABT) announced today that it is introducing the Libre Sense glucose sport biosensor for measuring athletes’ glucose. The company touts the Libre Sense as the world’s first glucose sport biosensor, using Abbott’s FreeStyle Libre continuous glucose monitor (CGM) technology to become the first personal-use product that allows for use beyond diabetes, according to a news […]
Fibralign wins CE mark for BioBridge tissue repair device
Stanford spin-out Fibralign announced that it received CE Mark approval in Europe for its BioBridge collagen matrix. Union City, Calif.-based Fibralign’s BioBridge has been designated as a Class III device with an indication for use in supporting lymphatic tissue repair and can be used after or in conjunction with surgical procedures addressing lymphedema, according to […]
Fitbit wins U.S., EU regulatory approval for ECG app
Fitbit (NYSE:FIT) announced today that it received FDA 510(k) and CE Mark clearance for its electrocardiogram (ECG) app. San Francisco-based Fitbit’s ECG app is designed to assess heart rhythm for atrial fibrillation (AFib), offering a simple method for on-the-spot readings, including whenever a user notices any unusual cardiac symptoms, according to a news release. The Fitbit […]