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 announces recall of insulin delivery pods
Small tears were found on the inside of some of Insulet Corporation's Omnipod 5 pods. The issue was linked to a total of 18 serious adverse events.
New dyslipidemia guideline puts add-on testing, early screening in the spotlight
The updated recommendations represent a collaboration between the American College of Cardiology, American Heart Association and several other U.S. healthcare organizations.
Veterans facing significant challenges accessing radiology services, VA watchdog says
In one instance, a veteran's wife reported difficulty scheduling a critical imaging appointment for her husband amid concern his cancer was spreading.
Data breach on care management company impacts 5K patients at NYC Health
Many of the details are unknown, as an investigation is ongoing. The National Association on Drug Abuse Programs said it became aware of an invasion of its network in January 2026. The nonprofit supports 35,000 people—mainly Medicaid enrollees—in the state of New York.
FDA merges all adverse event reporting systems into new AEMS platform
Adverse event reports for food, drugs, vaccines, dietary supplements and medical devices will soon be available in one place. The U.S. Food and Drug Administration said the change will simplify reporting for consumers and allow it to react in real-time to FOIA requests.

Nearly 600K bottles of blood pressure drug recalled due to carcinogen risk

The FDA has detailed three voluntary recalls for prazosin hydrochloride, a medication used to treat hypertension, due to safety concerns.

cvi42 | Plaque from Circle Cardiovascular Imaging

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.

Mammography services suspended at 2 hospitals following ACR review

A news release indicates the suspensions are due to breast images not meeting the college's clinical quality standards.

closing closure going out of business shutter

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.”

Recor Medical's Paradise Ultrasound Renal Denervation System

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.

Former CEO of Unite Us tapped as CMS’ Medicaid and CHIP lead

Dan Brillman, the former CEO and co-founder of coordinated care support service Unite Us, has left his position for a role in the Centers for Medicare & Medicaid Services, where he will be responsible for overseeing the federal government's safety net healthcare programs.

Policy & Regulations

FDA announces recall of insulin delivery pods

New dyslipidemia guideline puts add-on testing, early screening in the spotlight

Veterans facing significant challenges accessing radiology services, VA watchdog says

Data breach on care management company impacts 5K patients at NYC Health

FDA merges all adverse event reporting systems into new AEMS platform