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 clears new AI-enabled coronary plaque analysis software
Circle Cardiovascular Imaging, a Canadian medtech company, received the key approval for its cvi42 | Plaque platform.
Consolidation may be driving radiologists away from practicing as generalists
Radiologists who experienced a practice closure are more likely to operate as subspecialists afterward, according to new Neiman research.
FDA warns Philips after issues arise at multiple manufacturing facilities
Meanwhile, the Amsterdam-based imaging giant said it has already taken action to begin correcting these issues.
FDA accepts application for new Alzheimer’s PET imaging agent from Lantheus
The company is working to commercialize MK-6240, a radiodiagnostic that targets tau protein tangles—a “key hallmark of several neurodegenerative diseases.”
Medicare now covers renal denervation for patients with uncontrolled hypertension
This decision expands access to renal denervation to many more patients throughout the United States. Recor Medical and Medtronic both gained FDA approval for their RDN systems in 2023, and other vendors are actively developing their own treatment options.

FDA announces recall of dangerous arterial catheters

While there have been no reported injuries, a manufacturing error involving debris contamination could potentially kill a patient.

The U.S. Food and Drug Administration (FDA) has shared a new warning about ongoing safety issues with atherectomy devices sold and distributed by Bard Peripheral Vascular, an Arizona-based subsidiary of Becton, Dickinson and Company (BD). The warning includes multiple models of Bard Peripheral Vascular’s Rotarex Atherectomy System, which is designed to target high-risk plaques and blood clots in the peripheral arteries by rotating at a high speed.

FDA warns that atherectomy devices are breaking during use—30 serious injuries, 4 deaths reported

More than 100 incidents have been reported so far. The FDA is still evaluating this issue, but the agency wanted to raise awareness as quickly as possible.

artificial intelligence AI in healthcare

Healthcare AI Digest

People are still asking if AI will replace doctors or other healthcare workers.

Connecticut Democratic Senator Saud Anwar

State senator wants task force to study private equity’s impact on radiology

Connecticut Sen. Saud Anwar, MD, proposed Bill No. 489 last month amid concerns about care delays at Hartford-based Jefferson Radiology, an affiliate of Rad Partners.

Healthcare systems are proceeding apace with GenAI—and learning as they go

Last summer more than 40% of 121 hospital executives surveyed said their organization had already realized a decent ROI in generative AI. However, a C-suite slice of nearly the same size said it was too soon to know for sure.

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

HHS offers update on comms pause as rapid policy shifts continue

A spokesperson told HealthExec that "several types of external communications" are no longer subject to any pause, including urgent public health alerts.

insurance insurer payment claim denial reimbursement prior authorization

Physicians want Medicare Advantage plans to stop auto-denying imaging services

Payers have reportedly used artificial intelligence algorithms to deny routine requests for PET imaging, instead steering patients to CCTA in some cases.

FDA announces emergency recall of oxygen concentrators after spontaneous fires

There have been no injuries. However, due to the serious risk of death, the devices manufactured by Jiangsu Jumao X-Care Medical Equipment must be removed from the market immediately.

Policy & Regulations

FDA clears new AI-enabled coronary plaque analysis software

Consolidation may be driving radiologists away from practicing as generalists

FDA warns Philips after issues arise at multiple manufacturing facilities

FDA accepts application for new Alzheimer’s PET imaging agent from Lantheus

Medicare now covers renal denervation for patients with uncontrolled hypertension