The U.K.’s National Health Service reported June 10 that patients in the U.K. will be the first in Europe to enjoy the benefits of the Edison ultrasound histotripsy for ablation of liver cancer tumors as part of an effort to bring products to market more quickly to deal with unmet needs.

Lex Diagnostics Ltd. has submitted dual applications to the U.S. FDA seeking 510(k) clearance and CLIA waiver status for its Velo system, an ultra-fast point-of-care molecular diagnostics platform. The move comes after the recent news from Quidelortho Corp. that it intends to acquire Lex for $100 million following U.S. regulatory approval of the technology.

The trade wars spanning the globe lined up some unlikely-seeming adversaries, and such is the case in the trade scrum between the EU and China.

Newel Health srl received CE mark certification under the European Medical Device Regulation for Amicomed, its digital therapeutic solution for hypertension management. The app, which was cleared as a class IIa medical device, provides clinical insights and behavioral tools to help individuals manage their blood pressure.

The European Commission is seeking feedback from stakeholders on the oversight of high-risk AI products, one objective of which is to develop a series of guidelines for classification of high-risk AI systems – a consideration of great interest to med-tech firms doing business in the EU.

Aiatella Oy secured €2 million (US$2.28 million) in funding for its AI-powered cardiovascular imaging technology. The funds will be used to conduct clinical trials and develop the company’s ultrasound-based preventative screening tool, which detects and quantifies carotid artery narrowing in minutes.

Researchers at ETH Zürich developed Menstruai, a device that detects in menstruation blood biomarkers associated with certain diseases. Menstruai uses a sensor built into a sanitary pad and changes color if certain biomarkers are present. The first of its kind technology has the potential to enable the early detection of diseases and transform women’s health care.

South Korea’s pharmaceutical exports rose nearly 18% year-on-year to reach $2.56 billion in the first quarter (Q1) this year, according to the Korea Health Industry Development Institute. Medical device exports, however, dropped about 5% in Q1 2025 to $1.39 billion, attributed to a drop in trade of implant products to both China and the U.S.

Amber Implants BV reported no device-related adverse events were seen in any of the patients fitted with its Vcfix spinal system, which treats vertebral compression fractures, at one-year. Data from the first-in-human trial of the device also showed patients experienced a significant reduction in their pain levels.

The U.K. National Institute for Health and Care Excellence reported it will streamline its health technology assessment, but the bigger news might be that the agency will no longer require new technologies prove to be cost saving to win an endorsement from the agency.