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.
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.
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.”

Industry Watcher’s Digest

Last week’s blastoff of the Chinese AI company DeepSeek struck many like a cold bucket of water in the face.

FDA warns of cybersecurity vulnerabilities in patient monitors

The agency said Contec and Epsimed monitors connected via WiFi are particularly susceptible to cyberattack and could be used to gain access to hospital systems.

Medicare Advantage faces criticism for administrative burdens, pushing doctors to opt out

Medical Group Management Association (MGMA) Senior Vice of Government Affairs, Anders Gilberg, explains the frustration surrounding the Medicare Advantage program.

Blood pressure drug recalled due to black contaminants—FDA highlights safety risks

The recall was put in place after a customer discovered “visible black particulate matter” in a sealed vial. If the contaminant enters a patient's blood vessels, it could lead to serious complications, including a stroke or even death.

ACR shares guidance to help members deal with confusing White House executive orders

A string of executive orders from the White House created serious concerns among radiologists and other healthcare providers throughout the United States. The American College of Radiology issued a statement to help guide its members through the chaos.

Trump backtracks on federal funding pause after Medicaid chaos

A federal judge also halted the order, which instructed federal agencies to “temporarily pause all activities related to obligation or disbursement of all federal financial assistance."

New radiotracers outperform FDA-approved agent for detection of tau tangles.

Radiotracers on FDA’s fast track exceed performance of already approved tau-detecting agent

If approved, the two agents could offer providers greater insight into the process of patients’ neurodegeneration.

Melissa Davis, MD, MBA, Yale University, explains her research into private equity market penetration in radiology.

Concerns about private equity's growing influence in radiology

Melissa Davis, MD, vice chair of medical informatics and associate professor at Yale University’s Department of Radiology and Biomedical Imaging, shares her findings from research on private equity market penetration.

Policy & Regulations

FDA clears new AI-enabled coronary plaque analysis software

Mammography services suspended at 2 hospitals following ACR review

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