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BioWorld - Saturday, January 17, 2026
Home » Topics » U.S., BioWorld MedTech

U.S., BioWorld MedTech
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Pills, bottle atop $100 bill

US to impose ‘kind reciprocal’ tariffs on country-by-country basis

April 2, 2025
By Mari Serebrov
After several on-again, off-again tariff threats, U.S. President Donald Trump made it official April 2: Beginning immediately, the U.S. will levy “kind reciprocal” tariffs on countries across the world. Focusing on the numbers, Trump didn’t mention whether any goods would be exempt from the new tariffs, and the executive order he signed at the Rose Garden ceremony wasn’t available as of press time. However, in concluding his remarks, Trump said the pharmaceutical industry would “come roaring back” in the U.S., because if biopharma companies don’t, they will be facing big taxes.
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US flag and HHS logo

Kennedy called to Senate HELP hearing on HHS reorg

April 2, 2025
By Mari Serebrov
U.S. Sens. Bill Cassidy, R-La., and Bernie Sanders, I-Vt., invited Robert Kennedy to testify April 10 before the Senate Health, Education, Labor and Pensions (HELP) Committee for the first time in his capacity as Health and Human Services (HHS) secretary. The HELP invitation went out April 1 amid an outcry as thousands of employees across HHS agencies were being notified of their immediate termination and many lawmakers demanded answers about the mass layoffs.
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4-9-Abbott-Triclip.png
AAC25

Hospitalizations decline shows clearer benefit in Triclip study

April 1, 2025
By Annette Boyle
The two-year results of TRILUMINATE trial showed the first objective benefit to use of Abbott Laboratories’ Triclip transcatheter tricuspid edge-to-edge repair device in a presentation at ACC.25, the American College of Cardiology’s annual scientific session held March 29-31 in Chicago and simultaneously published in Circulation.
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Edwards-SAPIEN3-12-6.png

Edwards’ Early TAVR refutes surveillance recs for aortic stenosis

April 1, 2025
By Annette Boyle
Don’t wait. Edwards Lifesciences Corp.’s additional insights from the Early TAVR trial showed a clear benefit for transcatheter aortic valve replacement (TAVR) in patients with asymptomatic aortic stenosis.
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U.S. flag on columned building

FDA’s loss in lawsuit opens door to LDT promotion

April 1, 2025
By Mark McCarty
The U.S. FDA famously lost a lawsuit over its final rule for regulation of lab-developed tests (LDTs), but Jeff Shapiro of King & Spalding told BioWorld that the implications of this decision go beyond FDA regulation of clinical lab operations.
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HHS Secretary Robert Kennedy

Where’s the ‘radical transparency’ Kennedy promised?

April 1, 2025
By Mari Serebrov
As the U.S. Department of Health and Human Services begins implementing its reorganization and reduction-in-force plan by sending out termination notices this week to 10,000 more employees across its agencies, top Democrats in Congress are demanding details about the plan.
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Evolut device image
ACC.25

At 5 years, TAVR as good as SAVR in low-risk patients

March 31, 2025
By Annette Boyle
Medtronic plc’s Evolut Low-Risk trial continued to show non-inferiority of transcatheter aortic valve replacement to surgical aortic valve replacement in terms of death or disabling stroke at five years in a late-breaking presentation at the American College of Cardiology’s Annual Scientific Session in Chicago on March 30.
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Blood pressure gauge, ECG and medication
ACC.25

AI-enhanced ECG readings beat clinicians and labs in identifying MI

March 31, 2025
By Annette Boyle
When every minute matters, quickly determining which patients in the emergency department need urgent care for myocardial infarction can save lives. Researchers at the University Hospital Münster in Münster, Germany, developed a deep learning model that can detect features on electrocardiograms that more accurately identifies which patients require urgent revascularization than clinicians and provides results faster than high-sensitivity troponin lab tests.
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Illustration of hole in vessel wall with repair process in progress

Sanofi adds to hemophilia arsenal with FDA nod for Qfitlia

March 31, 2025
By Jennifer Boggs
Sanofi SA gained U.S. FDA approval for fitusiran as a first-in-class siRNA therapy for hemophilia. Branded Qfitlia, the antithrombin-lowering therapy is indicated for use as a prophylactic treatment to prevent or reduce bleeding episodes in people with hemophilia A or B, with or without inhibitors.
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Marks’ departure intensifies regulatory uncertainty at US FDA

March 31, 2025
By Mari Serebrov
Peter Marks’ March 28 letter giving one week’s notice of his resignation as director of the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) is sending more ripples of uncertainty throughout the industry. Marks, who has helmed CBER for nearly a decade, blamed his departure on recently confirmed Health and Human Services (HHS) Secretary Robert Kennedy, who has made a career out of his anti-vaccine stance.
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