The Trump administration has made known that it intends to foster rapid adoption of AI, starting with a repeal of an executive order (EO) issued by the Biden administration. Now, the White House has issued an EO that would override state AI law, a move that addresses a task that Congress to date has failed to complete.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accendra, Biotronik, Curasight, Envue, Medipost, Owens & Minor, Soin Neuroscience, Teikoku Seiyaku.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Huxley Medical, Pearl.
Researchers at the University of Sydney have uncovered a mechanism that may explain why glioblastoma returns after treatment, and the world-first discovery offers new clues for future therapies. Glioblastoma is one of the deadliest brain cancers, accounting for about half of all brain tumors, with a median survival rate of just 15 months. Despite surgery and chemotherapy, more than 1,250 clinical trials over the past 20 years have struggled to improve survival rates.
Ultromics Ltd. secured a strategic investment from the American Heart Association's Go Red for Women Venture Fund to advance the use of its technology to help clinicians better identify women suffering from heart failure with preserved ejection fraction (HFpEF). The condition goes undiagnosed in millions of women, who are disproportionately affected by HFpEF. Ultromics’ Echogo Heart Failure software analyzes routine ultrasound scans to quantify heart function and identify patterns that signal HFpEF.
The FDA’s final guidance for the use of real-world evidence (RWE) was touted by FDA commissioner Marty Makary as opening the door to the use of existing de-identified data in premarket device submissions, but the final guidance lends also clarifies a couple of points about when an investigational device exemption will be needed for RWE studies.
Med-tech M&A value in 2025 totaled about $38.99 billion through November, reflecting a clear slowdown from 2024’s $57.92 billion and well below the peak years of 2021 and 2022, when 11-month totals exceeded $119 billion and $132 billion, respectively. Activity this year has been uneven, with a strong April ($9.04 billion) and July ($7.29 billion) accounting for a large share of the total, while several months posted relatively modest figures. November was particularly quiet, delivering just $5 million in M&A value, down sharply from $1.68 billion in October and marking the weakest month of the year.
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