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 approves 1st AI-enabled imaging device for breast cancer surgery
Manufacturer Perimeter Medical Imaging announced the news on March 3 after earning premarket approval for “Claire” (formerly the Perimeter OCT B-Series).
Bayer's MR contrast injection system cleared by FDA for expanded use
The updated clearance expands the system's labeled field strength compatibility; the change will allow MRI suites with scanners up to the 7T range to utilize the system.
AI-enabled lesion quantification tool earns new CPT code
The software gives clinicians detailed insight into how patients are responding to treatment based on changes in lesion size and metabolic activity, offering earlier opportunities to alter care plans.
Cardiologist surrenders medical license after faking penile cancer diagnosis
An interventional cardiologist has lost his ability to practice in multiple states after faking a cancer diagnosis, lying about his training and allegedly asking a colleague to falsify documents.
Radiology societies fight Medicare Administrative Contractor’s proposed coverage restriction
National Government Services is seeking to limit the use of thermal destruction of the intraosseous basivertebral nerve, aka the Intracept procedure, drawing ire from ACR and SIR.

Pennsylvania, South Carolina propose requiring insurers to cover breast MRI, ultrasound

Gaps in coverage result in individuals paying anywhere from $234 for a follow-up diagnostic mammogram to over $1,000 for a breast MRI, Komen estimates.

Report: Incoming Trump executive order to eliminate ‘thousands’ of jobs at HHS

According to coverage in the Wall Street Journal, leadership at HHS has been told to rank probationary workers as the Trump Administration prepares to announce cuts. The White House denies the claim.

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.

Policy & Regulations

FDA approves 1st AI-enabled imaging device for breast cancer surgery

Bayer's MR contrast injection system cleared by FDA for expanded use

AI-enabled lesion quantification tool earns new CPT code

Cardiologist surrenders medical license after faking penile cancer diagnosis

Radiology societies fight Medicare Administrative Contractor’s proposed coverage restriction