Overture’s DaVitri system aims to make egg thawing and freezing processes during IVF more consistent to improve successful ...

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 ...

DaVitri becomes the first automated device cleared in the EU or U.S. for the vitrification of unfertilized eggs and the first freezing system approved with a blastocyst-rate performance claim ...

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 ...

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 ...

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 ...

Stereotaxis STXS recently received a CE mark in Europe for GenesisX — a next-generation robotic system. The company also submitted a 510(k) application to the FDA in the United States for the same.