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.

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.
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.

GE HealthCare issues recall of C-arms due to missing shielding components

The Class 2 recall pertains to the system's built-in shielding and collimation accessories.

Recor Medical gains historic approval for its ultrasound RDN system

Recor Medical's Paradise Ultrasound Renal Denervation System is the first medical device approved for the treatment of hypertension in Japan. It first gained FDA approval back in 2023.

FDA changes imaging recommendations for patients taking popular Alzheimer's drug

Leqembi (lecanemab) was approved by the FDA in 2023. It is an infusion drug that has been shown to reduce Alzheimer’s-related cognitive decline by up to 27%.

UnitedHealthcare sues Radiology Partners again, claiming mega practice ‘weaponized’ surprise billing protections

Rad Partners "firmly" denied the allegations, which mirror a similar complaint from Aetna, contending it plans to "vigorously defend against these claims" in court.

Federal update would help imaging centers, rad practices qualify for small business loans

The Small Business Administration will raise receipts-based standards for 263 industries including imaging, allowing more to apply for financing.

FDA shares concerns about new imaging agent, sinking shares for radiopharma firm Telix

The company is seeking approval for TLX250-CDx (brand name Zircaix), a novel PET (positron emission tomography) product geared toward kidney cancer.

FDA announces recall of Integra applicators due to sanitation risk

Multiple lots of extended tip applicators from Integra LifeSciences could put patients at risk of serious infection, prompting the FDA to designate the recall as Class I.

Recent fraud cases suggest ‘fake nursing’ has become a troubling career path

A new report reveals that states are keeping databases on “imposter nurses” to slow what could be a growing trend of unlicensed individuals holding nursing positions at hospitals nationwide.

Policy & Regulations

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

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