The Alphafold machine learning system for predicting a protein’s structure from its amino acid sequence has been adapted to make it possible to design de novo proteins that fold in a particular way and bind to prespecified target proteins. The sister system, called Alphadesign, works by generating random strings of amino acids, using Alphafold to predict their structure, and then iteratively optimizing the design.

The U.K. Medicines and Healthcare Products Regulatory Agency is reminding industry that several new regulatory requirements are in effect as of June 16, 2025, such as a postmarket surveillance rule that says manufacturers have only 15 days to report serious incidents to the agency.

Aortyx SL secured €13.8 million (US$15.9 million) in a series A funding round for its solution which treats aortic dissection. The company developed a system to repair the aortic tear, which includes a biomimetic, bioresorbable adhesive patch inserted in the aorta using an endovascular catheter and a deployer.

Wandercraft SAS secured $75 million in funding in a series D round to grow its AI-powered robotics solutions. Funds will be spent on its exoskeletons, Atalante X and Eve, as well as on the industrial development and rollout of Calvin 40, its humanoid robot.

Fineheart SA will soon begin a first-in-human study of Flowmaker, its fully implantable left ventricular assist device, in France, after receiving authorization from the French National Agency for the Safety of Medicines and Health Products to initiate the trial.

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.