The European Commission posted a series of proposed legislative updates, including the AI Act, which might not come into force for the med tech industry until August 2028 under the terms of this proposal.

U.S. and European organ-on-a-chip specialty biotechnology companies are driving development of organ-on-a-chip technologies, fueled by the U.S. FDA’s decision to phase out animal testing for investigational new drugs.

Growth factor specialist Agomab Therapeutics NV is now preparing to move into phase IIb development after delivering positive phase IIa results for its lead program, ontunisertib, an orally available treatment for fibrostenosing Crohn’s disease.

The health care sector continues to be strong and adaptable despite the challenges over the past year, according to a report by global investment bank Jefferies. High interest rates, geopolitical uncertainty and policy shifts have added caution to the industry, but leaders are adapting well.

Medtronic plc posted solid fiscal year second-quarter results led by the cardiovascular business with 9.3% growth. The Affera Sphere-9 pulsed field ablation system tripled the company’s sales in the hot PFA segment and pushed the cardiac ablation solutions unit to 71% growth, a nice uptick from the nearly 50% seen in its Q1.

DNA damage response specialist Artios Ltd. has closed an oversubscribed $115 million series D after delivering positive phase I/IIa data for its two lead programs.

Fresh cash infusions are on the way for European biotech after two leading venture capital firms announced large new funds. Asset-focused Medicxi has closed an oversubscribed €500 million (US$580 million) fund, while Sofinnova Partners exceeded its target of €500 million to close its Capital XI fund at €650 million (US$753.5 million).

While Europe’s biotech sector continues to face headwinds, med tech appears to be weathering the storm more effectively. Uncertainty in the U.S., heightened competition from China and a persistent lack of capital are all impacting the investment landscape, delegates heard at the LSX Investival Showcase in London.

A rapid diagnostic test from Ocean Dx SAS delivered gold standard performance in a clinical evaluation that points to a potential shift in how sepsis is identified and treated. The assay, which detects more than 1,000 bacterial species directly from whole blood, returned 100% sensitivity and 100% specificity compared with reference blood cultures, with results reported in five hours. Further, the test tripled the number of infections identified.

Fifteen years since the first patient was treated, and after being ditched by two companies, the EMA is recommending approval of Waskyra (etuvetidigene autotemcel), the first gene therapy for treating Wiskott-Aldrich syndrome.