The U.S. FDA’s January 2025 draft guidance for AI-enabled device software functions has not fared well in terms of industry response. Two major trade associations argue that the draft is at least somewhat redundant with existing agency guidance.

U.S. FDA warning letters typically have a noticeable effect on device manufacturing operations, but in the case of Q’Apel Medical Inc., a warning letter led to the withdrawal of a product for which the company made changes that were not cleared by the agency.

Nearly three weeks into the job, U.S. FDA Commissioner Marty Makary provided a comprehensive overview of his vision for the much-reduced agency, even as he’s taking first steps to implement his agenda.

First quarter earnings reports from Johnson & Johnson and Abbott Laboratories provided some surprising insights into the likely hit med-tech companies will sustain with current tariffs. The main takeaway? The impact of the trade war with China is far greater than expected by most analysts.

The U.S. Centers for Medicare & Medicaid Services decided to peel back a series of local coverage determinations for skin substitute grafts that provoked a vigorous response from stakeholders.

The next major shock wave to hit the U.S. biopharma and med-tech industries could be the fiscal 2026 federal budget. Nearly one-third of the discretionary budget for the Department of Health and Human Services (HHS) could be wiped out, according to the White House Office of Management and Budget’s “pre-decisional” budget proposal, or passback, for HHS.

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.

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.