FDA to add ‘black box’ warning to COVID shots? | AI regulation wars ramp up | $32M for family of infant fed cow’s formula

The label is the most serious warning the agency can place on pharmaceuticals, denoting substances that carry serious health risks that must be weighed against benefits. CNN was the first to report the news, citing two sources familiar with the matter. 

State-level regulation of AI: President Trump has turned his thinking into action.

Yale New Haven failed to notify parents about the use of the cow-based formula, which they expressly asked staff not to use. A judge found that the hospital failed to stock a human alternative, known to be safer for premature newborns. 

A U.S. state is enjoying $50 million in annual savings after imposing price caps on its hospitals. OK—but what good things (or workers) got sacrificed?

In a new data analysis from nine states, the Centers for Disease Control and Prevention found that the protective effect tapers off as juveniles age, with 5-17 year olds seeing fewer trips to urgent care or the emergency room at a rate of 56%. Overall, the agency said evidence shows that COVID-19 vaccines are still effective.

Paxton says the “woke” EHR giant is intentionally making it harder for patients and families to access historical medical data, violating state law. Epic denies the allegation.

According to attorneys representing a potential class action of plaintiffs, Sharp HealthCare was not forthcoming about its use of a tool for automatic note-taking. The technology allegedly captures everything said in an exam room, including sensitive details on diagnoses, and sends it to an offsite server.

The deal will not be finalized until approved by Exact Sciences’ shareholders. With it, Abbott gains control of new diagnostic tools, including a popular at-home test for colorectal cancer.

The agency is accused of failing to respond to a records request related to its upcoming review of the legality of abortion pills and interstate prescribing practices. The ACLU is asking a federal judge to enforce FOIA law.

San Diego-based Vektor Medical first secured FDA clearance for the AI-powered technology back in 2021. This updated announcement covers the latest version, which includes atrial flutter mapping and several other new features.

Published Friday in JAMA, scientists recently explored a risk-based mammography tactic that tailors regular imaging regimens to each individual’s danger of developing the disease.