In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. These directives provide the basic definition of a medical ...

CAMBRIDGE, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- SurgiBox, a medical technology company committed to improving access to safe, clean surgery at the point of need, announced today it has received ...

WASHINGTON & TEWKSBURY, Mass., Mitralign, Inc., an innovative developer of direct transcatheter mitral and tricuspid valve repair solutions, today announced its Mitralign Percutaneous Annuloplasty ...

Despite the fact that the CE mark has been around for more than 15 years, its meaning and importance are often not well understood by those who wish to market their products in Europe, as well as the ...

EINDHOVEN, the Netherlands, Sept. 08, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD – US ADR: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, ...

VANCOUVER, British Columbia--(BUSINESS WIRE)--Kardium Inc. has received CE mark approval for its Globe Mapping and Ablation System – the most complete solution for the treatment of atrial fibrillation ...

Intuitive Surgical’s is more than a one-track mind. Case in point: In the same breath that it announced the European clearance of one of its robotic surgery systems, the company also shared that it ...

New Clarius PAL HD3 ultrasound scanner is now available in the European Union and United Kingdom to enable hospital physicians and nurses to quickly diagnose and guide treatment for patients at the ...

Varian’s Halcyon and Ethos radiotherapy systems received two regulatory nods in short succession, with both U.S. FDA 510(k) clearance and CE marking. In addition, the company reported that the first ...

Beyond Air (XAIR) announced European CE mark approval of the LungFit PH system. This CE mark approval allows Beyond Air to market LungFit PH in the European Union and all other countries that ...