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. 

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Report highlights flaws in FDA rapid approval of Alzheimer drug

A new report from the Office of the Inspector General found the FDA failed to properly record meetings with drug manufacturers, ultimately approving drugs later shown to have safety and efficacy issues. 

FDA announces another recall for surgical devices over safety concerns—7 new injuries reported

Maquet Cardiovascular, a subsidiary of Getinge, is recalling two of its endoscopic vessel harvesting devices due to issues with different pieces bending, peeling or detaching during use. Some of the company's other EVH devices were recently involved in a separate recall for similar reasons. 

Anthem

Q&A: Vulnerable patients hit hardest by anesthesia reimbursement cuts

Tracy Young, CRNA, vice president at the American Association of Nurse Anesthesiology, details the ongoing fight between providers and insurers over how anesthesiologists get paid. 

Recor Medical's Paradise Ultrasound Renal Denervation System

Momentum continues for renal denervation as CMS considers national Medicare coverage

CMS is accepting public comments on the topic for a period of 30 days. Recor Medical and Medtronic have both shared statements in support of the potential policy shift.

4 ways HHS plans to help shape a national strategy for healthcare AI

HHS has thought through the ways AI can and should become an integral part of healthcare, human services and public health. Last Friday—possibly just days ahead of seating a new secretary—the agency released a detailed plan for getting there from here.

johnson & johnson branding

Johnson & Johnson buys depression drug and its manufacturer for $15B

The drug Caplyta, owned by Intra-Cellular Therapies, is being used to treat bipolar disorder and schizophrenia. In 2024, it brought in more than $481 million in sales. 

the words "FDA recall" on a board

FDA announces recall after Philips heart monitor software failed to send alerts—multiple deaths reported

Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry devices after certain high-risk ECG events were never routed to trained cardiology technicians as intended. The issue, which lasted for two years, has been linked to more than 100 injuries. 

HRS President Ken Ellenbogen, MD, FHRS, explains the need for the Heart Rhythm Advocates lobby group in Washington, D.C. to push for policies in Congress over reimbursements.

Why electrophysiologists needed a champion in Washington

Heart Rhythm Society President Kenneth A. Ellenbogen, MD, detailed a new advocacy group focused on improving EP reimbursements, patient care and access. “If you’re not at the table, you’re on the menu," he said.

Around the web

No devices need to be returned at this time. However, the FDA warned, using these heart pumps without reviewing the updated instructions could result in "serious injury or death.” 

The FDA recently cleared the company's cable-free, credit card-sized heart monitor that produces 12-lead ECGs.

If 25% tariffs go into effect, it could have a big impact on the cost of medical imaging and radiotherapy systems, with many manufacturing facilities in Mexico.