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.”

Looming fear of more IV shortages as Hurricane Rafael gains strength

The IV solution supply chain is still recovering after Hurricane Helene damaged a manufacturing site in North Carolina.

Renal denervation systems from Recor Medical, Medtronic receive new outpatient payments

Both FDA-approved systems previously received inpatient payments in August.

Walgreens settles class-action fraud lawsuit for $100M

The pharmacy chain is accused of charging insurance more for generic drugs than uninsured customers of its Prescription Saving Club.

Appeals court overrules radiologists’ previous win in No Surprises Act fight

This marks a rare victory for the Biden administration and federal agencies seeking to uphold provisions of the No Surprises Act.

hospital sustainability joint commission

Boston Medical Center installs solar panels to pay patients’ electric bills

A program dubbed the Clean Power Prescription sends half the energy generated by 519 solar panels on the hospital's roof back to patients, in the form of energy credits.

Medicare to boost payment for certain diagnostic imaging agents

CMS is moving forward with a proposal to issue separate reimbursement for radiopharmaceuticals—a change long lobbied for by the imaging industry.

Medicare to more than double reimbursement for CCTA, likely spurring greater demand

Beginning Jan. 1, CMS will up the rate for cardiac computed tomography angiography from $175 to $357.13, "encouraging broader use for better patient outcomes.”

artificial intelligence AI in healthcare

Industry Watcher’s Digest

Michelle Tarver, MD, PhD, has her work cut out for her.

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