The recent staff cuts at the U.S. FDA’s device center caught the attention of outsiders but also caught the attention of those who work on premarket applications for 510(k) and PMA filings.

Radnet Inc. expanded its commitment to the use of AI in improving diagnosis of breast cancer with an all-stock purchase of Icad Inc. for approximately $103 million. The transaction is expected to close in the second or third quarter of 2025.

The American Medical Association’s CPT editorial panel will meet May 1-3 to consider codes for several devices and services, but the most important of these might be the code for cardiac contractility modulation.

In a blast from the past, U.S. President Donald Trump signed an executive order April 15 to deliver on his 2016 campaign promises and strengthen or reinstate efforts of his first administration to drive down prescription drug prices. “My first term included numerous significant actions, including some of the most aggressive in recent history, to deliver lower prescription drug prices to American patients,” Trump noted in the order, which builds on many of those actions, including increased competition, re-importation, price transparency and a mandate to pass discounts through to patients.

The Trump administration sent several signals about the imposition of tariffs on semiconductors – a vital component for many devices. While imaging systems sell infrequently and may not suffer from a short-term crimp in supplies of semiconductors, items such as pacemakers sell by the hundreds of thousands each year in the U.S. a fact that makes semiconductor products a crucial component of the well-being of millions of Americans.

Johnson & Johnson’s Medtech division reported the completion of the first cases in the clinical trial for the Ottava robotic surgical system. The cases mark the first clinical experience with the Ottava system, which has been a long time in development.

The Center for Medicare and Medicaid Innovation was founded with the objective of reducing Medicare spending, but many of the associated programs will be stood down by the end of this year thanks in part to a 2023 report detailing a significant increase, rather than a decrease, in spending associated with CMMI programs.

Remegen Co. Ltd. emerged as a surprise challenger in the generalized myasthenia gravis space, unveiling positive phase III data of its China-approved lupus drug, telitacicept (RCT-18; Tai’ai), in the rare autoimmune neuromuscular disorder at the 2025 American Academy of Neurology conference.