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Health systems are racing to adopt AI. But can they prove its value?
Deep Dive

Health systems are racing to adopt AI. But can they prove its value?

At the HLTH 2025 conference held in Las Vegas last week, experts said healthcare organizations are racing to deploy artificial intelligence across their organizations, but how to measure the return on these investments is not always clear. AI technologies, including ambient documentation, summarization tools, and revenue cycle management products, require financial investment and time to implement. Experts noted that the ways in which AI generates hard dollar returns are not always obvious, which is crucial for justifying expenditures and measuring success.

AI could transform healthcare. Can safety-net providers keep up?
Deep Dive

AI could transform healthcare. Can safety-net providers keep up?

Artificial intelligence has the potential to ease clinicians' workloads and improve care, yet resource-strapped safety-net providers face severe challenges in technology implementation, talent acquisition, and funding, which may widen the digital divide.

How three companies are using foundation models in radiology
Deep Dive

How three companies are using foundation models in radiology

Radiology is becoming the first sector in healthcare technology to adopt foundation models. HOPPR trains models on licensed data and offers them to third parties for fine-tuning, Aidoc has received FDA clearance for two derived models, and Radiology Partners is piloting two tools based on large language and vision models. Experts note that despite the significant technical potential, clinical benefits still need validation, and deployment involves substantial training and workflow integration efforts.

Four Major Trends in Medical Technology for the Second Half of 2025: M&A Recovery, Renal Denervation, MDUFA Negotiations, and the Hugo Surgical Robot
Deep Dive

Four Major Trends in Medical Technology for the Second Half of 2025: M&A Recovery, Renal Denervation, MDUFA Negotiations, and the Hugo Surgical Robot

Halfway through 2025, medical technology companies are gradually clarifying their direction for the second half of the year. After a slowdown in spring M&A, deal activity is heating up again; Medtronic is accelerating its challenge to Intuitive Surgical's surgical robot market, while Medicare is expanding coverage for hypertension device therapies. Meanwhile, under the leadership of new head Martin Makary, the FDA is beginning to outline its regulatory path and negotiate fees to charge the industry in the coming years. Despite lingering uncertainties such as tariffs, device companies are advancing their growth plans.

Legal experts question legality of HHS mass layoffs
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Legal experts question legality of HHS mass layoffs

The mass layoffs at the U.S. Department of Health and Human Services (HHS) may violate federal law. Legal experts point out multiple irregularities in the layoff process, including the closure of statutory offices, failure to rank employees according to rules, and erroneous notifications. Unions and law firms have intervened and may file a class-action lawsuit.

FDA's LDT Regulation Plan Rejected by Court, What's Next for the Industry?
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FDA's LDT Regulation Plan Rejected by Court, What's Next for the Industry?

On March 31, a U.S. federal court ruled to strike down the FDA's final rule regulating laboratory-developed tests (LDTs) as medical devices. Industry insiders analyze that the FDA is unlikely to appeal, and the focus of regulatory reform will shift to congressional legislation, but the likelihood of passing a bill in the short term is low.

Five Key Recommendations for Building a Predetermined Change Control Plan
Deep Dive

Five Key Recommendations for Building a Predetermined Change Control Plan

The Predetermined Change Control Plan (PCCP) allows medical device manufacturers to pre-declare anticipated post-market changes to the FDA, addressing regulatory challenges posed by frequent AI software updates. Although the framework has been recognized by the FDA, many companies still do not adopt it due to unfamiliarity or a lack of long-term planning. Based on expert interviews with MedTech Dive, this article distills five practical recommendations regarding PCCP.