The American College of Cardiology (ACC) and the American Heart Association (AHA) issued new scientific statements advocating use of quantified coronary plaque analyses in management of patients with coronary artery disease. The statements move plaque analysis based on AI-powered coronary computed tomography angiography to a defined clinical consideration in cardiac management, up from "an emerging technology."

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.

Eli Lilly and Co. took another step toward adding a way for patients to hang onto their weight loss when the firm disclosed positive top-line data from the phase III Attain-Maintain trial with orforglipron, a once-daily oral small molecule GLP-1 receptor agonist. Indianapolis-based Lilly said that at one year orforglipron met the primary and all key secondary endpoints vs. placebo, delivering superior weight maintenance as an adjunct to a healthy diet and physical activity, using the efficacy estimand and modified treatment-regimen estimand.

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.

The U.S. FDA announced Dec. 15 that it will take a more relaxed approach regarding the use of real-world evidence (RWE) in drug and device application reviews. Specifically, new guidance for device premarket applications will not require identifiable individual patient data collected from real-world data sources, and the agency indicated it intends to consider similarly updating guidance regarding submissions for drugs and biologics.

Addition Therapeutics came out of stealth mode to highlight its Precise RNA-Mediated Insertion of Transgenes (PRINT) gene therapy platform. The system is based on research of retrotransposons by Kathleen Collins’ laboratory at University of California, Berkeley, that was spun out into Addition in 2021.

Harbour Biomed has added another collaboration to its end-of-year dealmaking, this time with Bristol Myers Squibb Co. (BMS) to develop multispecific antibodies. Harbour is getting about $90 million up front, but milestones could eventually top $1 billion.

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.