Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies.

FDA confirms Class I recall for Johnson & Johnson devices due to durability concerns
The issue, first reported in September, was linked to five patient injuries. Devices not being actively used should be returned to Johnson & Johnson MedTech for updates.
FDA announces recall of ultrasound systems impacted by software glitch
The inaccurate measurements could lead to misdiagnoses or improper treatment, a regulatory notice suggests.
Novartis seeks to expand use of prostate therapy Pluvicto, citing positive trial results
An expanded approval could potentially double the number of patients eligible for treatment with the therapy, first approved in 2022.
FDA approves oral semaglutide for reducing cardiovascular risks in adults with type 2 diabetes
Rybelsus from Novo Nordisk is officially the first oral GLP-1 drug approved for this indication. The FDA's decision was based on the SOUL trial, which included data from more than 9,000 patients with type 2 diabetes.
Judge blocks Trump's shutdown layoffs—1,200 HHS workers spared for now
U.S. District Court Judge Susan Illston said the firings appear to be politically motivated and may exceed the authority of the executive branch. She sided against the Trump administration, issuing a temporary restraining order to stop 4,200 federal employees from being fired.

Healthcare AI today: Nurses called to AI action, Big Beautiful Law, of mice and AI, more

If nurses fail to lead the way toward safe and responsible use of healthcare AI, the profession may lose its voice on emerging technologies.

Congress Money washington DC legislation coverage payment

With MPFS proposal on the way, electrophysiology groups outline their priorities

The Heart Rhythm Society and its new advocacy arm plan on pushing CMS to include certain policy improvements in the 2026 MPFS.

U.S. Department of Health and Human Services (HHS) sign.

HHS, RFK sued by medical associations over COVID policy shift

Multiple professional groups, including the American Academy of Pediatrics and the American College of Physicians, challenge recent policy changes to vaccine recommendations for COVID-19, which end routine inoculations for minors and pregnant women.

What’s in the ‘Big, Beautiful Bill’—and what was left out?

Sweeping tax cuts and reduced spending on Medicaid and SNAP were signed into law by President Donald Trump. However, a key provision that would have paused new AI regulations was removed by the Senate.

Farapulse Boston Scientific Pulsed Field Ablation PFA fda approval

FDA expands approval of Boston Scientific’s Farapulse PFA system

The FDA's 2024 approval of the Farapulse system covered patients with paroxysmal atrial fibrillation. Now, however, the technology is officially approved for patients with more persistent symptoms.

President Trump finalizes spending bill with 2.5% rad pay bump, but no inflation-based Medicare reform

The bill also includes some $1 trillion in Medicaid cuts, with nearly 12 million kicked off insurance, drawing criticism from the American Medical Association and hospital lobbying groups.

Massive spending bill passes final vote in Congress with Medicaid cuts intact

The 940-page document passed the House of Representatives in a 218 to 214 vote, and now heads to President Donald Trump’s desk. It contains a 20% cut to federal Medicaid funding, something Trump said he opposes.

Radiation in the cath lab: Tracking state-level regulations for cardiologists

Researchers hope these policies can be standardized in the future to help avoid confusion and improve clinician safety.

Policy & Regulations

FDA confirms Class I recall for Johnson & Johnson devices due to durability concerns

FDA announces recall of ultrasound systems impacted by software glitch

Novartis seeks to expand use of prostate therapy Pluvicto, citing positive trial results

FDA approves oral semaglutide for reducing cardiovascular risks in adults with type 2 diabetes

Judge blocks Trump's shutdown layoffs—1,200 HHS workers spared for now