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.

Medtech startup co-founded by cardiologist seeks FDA clearance for new-look perfusion device
Tulyp Medical, a French medtech startup, has emerged from stealth focused on securing FDA clearance for a patented perfusion device.
FDA highlights new Class I recall for Dexcom CGM app
Dexcom recalled its G6 smartphone app after a software error was causing it to stop working with no warning. This is a Class I recall, which means failing to follow the company's instructions could result in a serious adverse event.
5 healthcare industry giants funnel over $333M in research payments to radiologists
Merck was the No. 1 funder for radiologists, contributing nearly $108 million in payments, followed by imaging manufacturer Siemens Healthineers ($64 million) and drugmaker Novartis ($57 million).
Report: CMS sent states lists of names for impromptu Medicaid eligibility check
President Donald Trump’s administration wants states to check to see if hundreds of thousands of residents are enrolled in Medicaid illegally. CMS provided a specific list of people it suspects are undocumented.
Medicare Physician Fee Schedule cuts cardiologist pay because CMS says doctors should be more efficient
The new, negative 2.5% efficiency adjustment will be applied to the vast majority of Medicare payments for physician services. It was opposed by cardiology and most other medical societies.

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: Where’s the AI ROI?, AI messaging truth check, AI burnout busters, more

Provider organizations are using generative AI for all sorts of use cases. It’s delivering impressive returns in two—tech support and patient experience.

Radiologists 'deeply concerned' about further tariffs on medical imaging devices

Last month, the Department of Commerce launched an investigation into the importing of such items, seeking to determine the impact on national security.

FDA clears RadNet imaging AI solution for detecting neurodegenerative disease

Authorities granted 510(k) clearance for Brain Health in late September, with the Los Angeles-based imaging center operator touting the decision Tuesday.

FDA clears AI-powered vascular imaging software

The new software provides automated measurements that save time and improve the care of aortic aneurysm patients.

Policy & Regulations

Medtech startup co-founded by cardiologist seeks FDA clearance for new-look perfusion device

FDA highlights new Class I recall for Dexcom CGM app

5 healthcare industry giants funnel over $333M in research payments to radiologists

Report: CMS sent states lists of names for impromptu Medicaid eligibility check

Medicare Physician Fee Schedule cuts cardiologist pay because CMS says doctors should be more efficient