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 […]
Boston Scientific launches Vercise Genus DBS system in Europe
Boston Scientific (NYSE:BSX) announced that it received CE Mark for its fourth-generation Vercise Genus deep brian stimulation system. Vercise Genus includes full-body MRI conditional and Bluetooth capabilities within a DBS system designed for treating the symptoms of Parkinson’s disease, essential tremor and dystonia by delivering electrical stimulation to targeted parts of the brain. Marlborough, Mass.-based Boston […]
Izi Medical compression fracture system lands CE mark
Interventional radiology device maker Izi Medical Products (Owings Mills, Md.) announced today that it has received the CE mark for its Kiva vertebral compression fracture (VCF) treatment system. Kiva is a unipedicular PEEK implant-based treatment system that is already available in the U.S. The implant is designed to mimic cancellous bone and provide structural support to prevent […]
Theranica lands CE mark for migraine device
Theranica announced today that it received CE Mark approval for its Nerivio device for the acute treatment of migraine. Montclair, N.J.-based Theranica adds European approval just over a year since it received FDA de novo clearance for the neurostimulation device in May 2019. The approval allows for the company to begin marketing the device in […]
Here’s how the UK will regulate medical devices after Brexit
The United Kingdom issued an outline of how it intends to regulate medical devices beginning in 2021 after Brexit. From Jan. 1, 2021, the responsibilities for the UK medical devices market that are currently governed by the European Union (EU) will be taken over by the Medicines and Healthcare products Regulatory Agency (MHRA), the guidance said. […]
Smith + Nephew launches Novostitch Pro meniscal repair system
Smith + Nephew (NYSE:SNN) announced today that it launched the Novostitch Pro meniscal repair system after winning CE Mark approval. London-based Smith + Nephew is launching the Novostitch Pro in Europe to expand meniscal repair options where the only previous option was removal, according to a news release. The system repairs meniscal tears and closes the […]
Osprey Medical jumps 8% on news of CE Mark
Osprey Medical (ASX:OSP) announced that it received CE Mark approval in Europe for its DyeVert Power XT second-generation device. Upon yesterday’s announcement of the regulatory milestone, shares of OSP jumped up nearly 8.6%. However, today, they are trading down -5.3% at 4¢ per share in mid-afternoon trading. Approval allows Osprey to market and sell its DyeVert […]
Rapid Medical receives CE mark approval for stentriever
Rapid Medical announced today that it received CE Mark approval in Europe for its Tigertriever XL stentriever device for treating ischemic stroke. Yokneam, Isreal-based Rapid Medical also said in a news release that the first patients were successfully treated with the device at Bochum University Hospital in Germany. Tigertriever XL joins the Tigertriever platform of […]
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