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.

CDC vaccine committee issues new guidance for COVID-19 shots

The Advisory Committee on Immunization Practices recommended that all Americans six months and older consult a clinician before deciding to get a COVID vaccine, ending the pandemic-era policy that broadly encouraged getting the inoculation.

Hundreds of radiation therapy systems subject to FDA recall

A Class 2 recall has been issued for the systems due to a software glitch that could impact treatment accuracy.

Healthcare AI today: Inflationary AI, China’s AI vs. ours, Joint Commission AI guidance, more

Picture yourself interacting with an AI model that can tell you when you might develop any of 1,000 disease conditions over the coming 10+ years. OK, now see yourself finding out such a model is already here.

Medicare money payment reimbursement dollar decline george washington

Radiology advocates say ‘excessive’ cut to Medicare practice-expense pay could imperil independent docs

CMS is trying to even out pay gaps between hospital and office-based physicians, but rad groups said the move lacks supporting data and could adversely impact interventinoal specialists.

5 signals EMS is ripe and ready for AI

Emergency medical services are there when you need them. Yet they barely come up in healthcare strategy discussions. AI could help change that.

Abbott has recalled its TactiFlex Ablation Catheter, Sensor Enabled, because of reports that the tip can separate.

Abbott warns EP labs the tip can detach from its TactiFlex ablation catheters

Improper removal of the catheter from the packaging can result in tip damage. Most damaged tips were detected prior to being used, but three tips did separate inside patients.

Chris Kramer ACC president will be moderating a global state of health meeting to help the UN better understand the need for investing in preventive care healthcare workers.

ACC: Global health workforce is in need of investment to combat noncommunicable diseases

The American College of Cardiology has committed to reducing morbidity and mortality from noncommunicable diseases by 30% by 2030, but significant investments will be needed to expand the healthcare workforce.

money maze benjamin franklin reimbursement medicare

Radiologists and other docs express growing frustration with Merit-based Incentive Payment System

Over 30 medical societies including the American College of Radiology recently wrote to CMS Administrator Mehmet C. Oz, MD, MBA, to voice their concerns.

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