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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Craniosense, Hardy Diagnostics, Pulse Biosciences.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cutera, Enable Injections, Femasys, J&J.
Medline Inc. returned to the public markets with a blockbuster IPO of $6.26 billion, reportedly this year’s largest IPO globally. The upsized offering of more than 216 million shares at $29 per share will allow the medical supply giant to devote the entirety of the proceeds from its initially proposed 179 million shares toward repayment of debt.
Acryl Inc. debuted on South Korea’s Kosdaq Dec. 16, raising ₩42.12 billion ($28.5 million) in an IPO. Shares (KOSDAQ:0007C0) closed at ₩67,000 on the first day, up 243.5% from its offering price, before closing 30% down on Dec. 17 at ₩47,500. Seoul, South Korea-based Acryl sold 2.16 million shares priced at ₩19,500 each. Notably, Acryl won South Korea Ministry of Food and Drug Safety approval of Acryl-D01 software in December 2024, making it the country’s first AI-based digital therapeutic solution for depression screening and diagnosis. The generative AI-based medical software is cleared to analyze patient interviews and medical records and provide a probability score for clinical depression.
The European Union’s struggles with regulations for devices and in vitro diagnostics seem virtually endless, but the European Commission floated a series of changes that would present a significant reset of both regulations. One of the more sweeping changes would be to exempt medical technologies from much of the text of the Artificial Intelligence Act, a move that would ease the drag on AI-based technologies in the EU.
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