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.

American College of Radiology, nuclear medicine society urge CMS to fix years-old billing code mistakes

SNMMI and ACR are pushing the agency to make modifications retroactive, so specialists can still claim lost revenues impacted by the error.

FDA warning letter: iRhythm committed multiple violations, failed to report patient deaths in time

“It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA,” according to the warning letter. These issues, the agency added, “may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.”

Startup scores FDA clearance for virtual reality tool that creates patient avatars via CT, MR images

Avatar Medical said its VR solution can serve as an aid in pre-operative planning or for use during procedures.

Merck Januvia Janumet Steglujan Nitroso-STG-19 (NTTP) type 2 diabetes

Merck sues US government over Medicare's drug price negotiation liberties, calls program a 'sham'

Merck believes the Inflation Reduction Act-launched effort “coerces” manufacturers to enter into agreements to sell their top products at a fraction of their actual value.

Incorrect place-of-service codes resulted in Medicare overpayments totaling in the millions

The audit revealed that Medicare overpaid by approximately $22.5 million due to incorrect place-of-service coding completed by practitioners.

Federal bill would require more transparency from private equity-backed physician practices

H.R. 3561 also would apply to groups owned by physicians, hospitals, insurers, or venture capital firms, who could face fines of $2M for failing to comply.

‘It was killing some of these radiology departments’: State grapples with long licensing delays

Some rad techs have waited upward of four months to receive their credentials, with it taking days prior to COVID.

FDA clears GE HealthCare MRI tool that can cut scan times by up to 83%

Sonic DL is powered by deep learning technology and targeted for use in cardiac MRI, the company said Monday.

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