The European Commission has proposed legislation that would ease some of the EU’s barriers to innovation, but MedTech Europe said that while the European Innovation Act would be helpful, it is no substitute for fixing what’s already ailing the EU med-tech industry.

Vertebral compression fractures are one of the more obvious signs of osteoporosis but can be difficult to diagnose, one of several reasons the U.K. National Institute for Health and Care Excellence has given the nod to five AI products that can improve rapid detection of these fractures.

Dewpoint Therapeutics Inc. has announced an IND in the U.S. for DPTX-3186, a first-in-class oral condensate modulator designed to selectively disrupt oncogenic Wnt/β-catenin signaling in tumors. Dosing is set to begin before year-end in a phase I/II trial conducted in partnership with cancer centers and opinion leaders in gastric and other Wnt-driven cancers.

San Diego-based Dexcom Inc., is the target of a class action lawsuit in U.S. district court over the company’s G7 continuous glucose monitors, an action which follows a U.S. FDA warning letter by a mere seven months and a recall announced in July, suggesting that litigation often follows other sources of bad news for firms in the med-tech business.

Sweeping “radical” changes in both the U.S. FDA and China’s drug development landscape are keeping the global life science industry on its toes in assessing what’s temporary and what’s not, speakers said at the Bioplus Interphex (BIX) Korea 2025 conference in Seoul, South Korea, on Oct. 15.

Proqr Therapeutics NV has received clinical trial application (CTA) authorization under the EMA’s new centralized review process for a phase I study of AX-0810, which is being developed for the treatment of cholestatic diseases such as primary sclerosing cholangitis and biliary atresia.

The U.K. Competition and Markets Authority (CMA) has issued draft guidelines for remedies for mergers and acquisitions, which the agency insists incorporates some regulatory flexibility. However, CMA said its approach is premised on the notion that any regulated transaction should have zero effect on competition in the affected industry, a premise that would seem to quash any transaction that leads to fewer companies in that industry.

The U.K. Medicines and Healthcare Products Regulatory Agency reported the winners of the second phase of the AI Airlock challenge, which includes the Tortus AI, a medical scribe system developed by physicians in the U.K. National Health Service.

The U.S. FDA approved 17 drugs in September 2025, following 18 approvals in August and 17 in July. That brings the year-to-date total to 160 approvals for the first three quarters, making it the second-highest total on record for this period, behind 183 approvals logged during the same timeframe in 2024.