The U.S. Centers for Medicare & Medicaid Services announced Jan. 15 that the estimated volume of improper payments for Medicare fee-for-service care in fiscal 2025 was nearly $29 billion while the number for Medicare managed care was in excess of $23 billion.

A new systematic review and meta-analysis of studies looking at a possible association between Tylenol (acetaminophen) use in pregnancy and neurodevelopmental disorders in children concludes there is no evidence of any meaningful risk. The study was carried out by researchers in the U.K., Italy, Sweden and Norway, in response to U.S. Secretary of Health and Human Services Robert Kennedy saying last September that there is a link. Unless medically necessary, it is “irresponsible” to take Tylenol during pregnancy, Kennedy said.

As the momentum and interest in brain-computer interface (BCI) technologies continue to accelerate, Merge Labs has emerged with an investment from OpenAI in its seed round. Merge Labs says it plans to develop next-generation BCIs capable of interacting with the brain at high bandwidth, integrating with advanced AI, and doing so in ways that are safe and accessible to everyone.

The Centers for Medicare & Medicaid Services has cracked open its coverage policy for transcatheter aortic valve replacement devices a second time, and a wide range of stakeholders are providing feedback. Where the agency will land on questions such as the need for continued evidence development is difficult to predict, however, given that the agency is hearing anything but unanimity on the question.

At a pair of panels on developing and selling drugs in Europe at the Biotech Showcase 2026 meeting in San Francisco, experts discussed the good, the bad and the ugly parts of the European drug development scene.

The EMA had its second busiest year ever in 2025, approving 104 drugs, of which 38 had a new active substance. Sixteen of these are for treating rare diseases, and four are advanced therapy medicinal products.

U.S. President Donald Trump unveiled his “Great Healthcare Plan” Jan. 15, an initiative he said would slash prescription drug prices, maximize price transparency in the health care system and hold big insurance companies accountable.

The U.S. FDA has endorsed ISO 14971 for risk management for medical device manufacturers, but there’s nothing compulsory about industry’s use of this standard. Nonetheless, Sarah Moore, principal program lead at NSF, told BioWorld that adoption of 14971 is still the most seamless way to demonstrate proper risk management practices to FDA field investigators, given that the alternative is almost always more work for both sides during facility inspections.