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BioWorld - Friday, February 20, 2026
Home » Topics » Medical technology, Regulatory

Medical technology, Regulatory
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Boston Scientific Farawave Nav

Boston Sci obtains CE mark for Farapulse navigation mapping system

Feb. 20, 2025
By Shani Alexander
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.
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Various pills laid across a target

Pharmaceuticals named as tariff target, starting at 25%

Feb. 19, 2025
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.”
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Monica Bertagnolli, former director, U.S. NIH
Policy

AAAS 2025: Former NIH head Bertagnolli sounds warning on funding cuts

Feb. 19, 2025
By Nuala Moran
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.
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Hand holding a pink slip or termination notice against a blurred office background

Thousands of US HHS staff terminated in name of efficiency

Feb. 18, 2025
By Mari Serebrov
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.
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Roche building

​US FDA clears Roche’s preeclampsia test

Feb. 14, 2025
By Annette Boyle
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.
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Wooden stamp with China flag

Microport’s laparoscopic surgical robot cleared in China

Feb. 14, 2025
By Marian (YoonJee) Chu
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.
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Regulatory-US-FDA-HQ.png

Uncertainty builds amid Kennedy confirmation, Trump’s orders

Feb. 13, 2025
By Mari Serebrov
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.
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United Kingdom flag, map

​MHRA sets up pilot program for real-world evidence​

Feb. 13, 2025
By Mark McCarty
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.
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European Union flag with wooden gavel

EC drops AI liability directive for now

Feb. 12, 2025
By Mark McCarty
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.
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Efforts revived to stem flow of US funding for China R&D

Feb. 11, 2025
By Mari Serebrov
The Biosecure Act may have died with the 118th U.S. Congress, but efforts to stop U.S. government funding of R&D in China are alive and well. Rep. Claudia Tenney, R-N.Y., introduced the Stop Funding our Adversaries Act in the House Feb. 7 to prohibit direct and indirect federal funding of research in China or entities owned by China.
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