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.

Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately
The FDA has categorized this as a Class I recall. If patients update their phone or watch apps as needed, they can continue to use these devices like normal.
Why all heart patients should be vaccinated against the flu, COVID-19, RSV
The American College of Cardiology has shared new recommendations highlighting the protective benefits of a variety of vaccines. The new guidance also examines how to speak with patients who are hesitant to be vaccinated.
Medicare has denied $16M worth of radiology artificial intelligence claims
The federal payment program first started paying for AI in 2018 and has denied about 53% of claims (or 53,857) submitted by radiologists since then, experts detail in JACR.
Members of Congress propose tapping foreign-born physicians to relieve radiology workforce shortages
Lawmakers in both chambers have reintroduced the Healthcare Workforce Resilience Act, touting support from the American Hospital Association and several physician societies.
Medicare opts not to make CT radiation-related quality measure mandatory in 2027
The measure evaluates the proportion of scans that exceed certain thresholds for image noise or radiation dose across 18 categories.

GE HealthCare stands on its own

GE has completed the spinoff of its healthcare business, and GE HealthCare began trading as its own entity on the Nasdaq Jan. 4.

Industry group pushes for cannabis screenings in surgery

The American Society of Regional Anesthesia and Pain Medicine (ASRA Pain Medicine) has released new guidelines surrounding cannabis use in relation to surgery, advocating for all patients undergoing procedures with anesthesia to be screened for cannabis use.

Nuclear Regulatory Commission to reconsider extravasation reporting requirements

The NRC noted that advancements in nuclear medicine and increased use of radiopharmaceuticals prompted the commission to reconsider the exclusion of extravasation from medical event reporting.

The Dexcom G7 Continuous Glucose Monitoring System

Regulatory Roundup: FDA news on omecamtiv mecarbil for HFrEF, 'world's smallest heart pump' and more

Read our monthly recap of some of the biggest FDA-related stories that have hit cardiology, including updates related to Cytokinetics, Dexcom and Abiomed.

GAO appoints 7 new members to health IT advisory committee

Seven members have been added to the Health Information Technology Advisory Committee (HITAC), a group tasked with improving the quality and access of health IT by the Government Accountability Office (GAO).

Healthcare leaders react to $1.7T government funding bill

Healthcare stakeholders throughout U.S. medicine, including radiology leaders, aren’t waiting for the ink to dry before speaking their minds.

Fluorescent imaging agent gets FDA nod for use during lung cancer surgery

A molecular contrast agent previously cleared for use during surgery for ovarian cancer may now be used in similar fashion during lung operations.

Mahadevappa Mahesh, PhD, professor of radiology and a medical physicist at the Johns Hopkins University School of Medicine, explains a new American College of Radiology (ACR) effort to ensure that lower radiation dose X-ray images under Image Wisely and As Low as Reasonable Achievable (ALARA) meet diagnostic reading standards. He spoke to Radiology Business at the Radiological Society of North America (RSNA) 2022 meeting.

VIDEO: Making sure lower dose X-ray is still diagnostic quality

Mahadevappa Mahesh, PhD, professor of radiology and a medical physicist at the Johns Hopkins University School of Medicine, explains a new ACR effort to ensure that lower radiation dose X-ray images under Image Wisely and As Low as Reasonable Achievable (ALARA) meet diagnostic reading standards.

Policy & Regulations

Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately

Why all heart patients should be vaccinated against the flu, COVID-19, RSV

Medicare has denied $16M worth of radiology artificial intelligence claims

Members of Congress propose tapping foreign-born physicians to relieve radiology workforce shortages

Medicare opts not to make CT radiation-related quality measure mandatory in 2027