With massive terminations, data removals, holds on U.S. government funding, cancellation of various programs and meetings, the potential for 25% tariffs on medical products and a multitude of court challenges and appeals, the dust is flying thick at the FDA, NIH and throughout the Department of Health and Human Services (HHS).

Boston Scientific Corp. recently received CE mark for its navigation-enabled Farawave Nav ablation catheter and Faraview mapping software to be used with its Farapulse pulsed field ablation (PFA) system. The technologies are expected to improve physicians’ understanding of patients’ atrial fibrillation to enable treatment using the Farapulse PFA system.

The prospect of U.S. tariffs on pharmaceuticals became more than just speculation this week, with President Donald Trump saying those tariffs likely would begin at 25% and climb over the year. His comments came in response to a question at a Feb. 18 news conference that followed the signing of two unrelated executive orders. Asked about the planned rate for tariffs on semiconductors and pharmaceuticals, Trump responded that it would be 25% and higher and it would “go very substantially higher over [the] course of a year.”

The former head of the U.S. NIH has sounded a warning that the uncertainty caused by the Trump Administration’s funding cuts and layoffs is blocking “critical work” and “paralyzing” biomedical research. “Every time we launch a new program, every time we continue to commit resources to ongoing work, those are important decisions that we make every single day, and in times like this, that decision-making is paralyzed,” said Monica Bertagnolli, who stood down as director of the NIH on Jan. 17.

As part of a U.S. government-wide reduction in force aimed at restructuring and streamlining federal agencies, 5,200 Health and Human Services employees reportedly received their pink slips over the weekend, with 1,165, or 22%, of those at the NIH.

With rates of preeclampsia skyrocketing, the U.S. FDA’s510(k) clearance of Roche Holding AG’s Elecsys test for preeclampsia offers some hope of reducing the number of women and infants who die or experience life-long consequences from the development of dangerously high blood pressure during late pregnancy and in the days immediately following delivery.

Shanghai Microport Medbot (Group) Co. Ltd. won China National Medical Products Administration approval of its self-developed Toumai single-arm and single-port laparoscopic surgical robot.

Coming as no surprise, the U.S. Senate’s Feb. 13 confirmation of Robert Kennedy as the next secretary of the Department of Health and Human Services (HHS) did nothing to ease the uncertainty hanging over the FDA and other HHS agencies.

The U.K. Medicines and Health Care Products Regulatory Agency reported a pilot program for the use of RWE in regulatory decision making, which is largely directed toward drug products.

The European Commission’s proposal for an AI-specific liability law seemed destined to pile onto existing EU liability law, but the commission reported it will pull the legislative proposal dubbed the AI Liability Directive.