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.”

artificial intelligence AI in healthcare

Healthcare-specific AI: How to multiply successes and head off accidents

Given the rapid proliferation of AI-equipped medical devices across U.S. healthcare, unintended effects should surprise no one.

Private-equity watchdog warns against nominating Marc Rowan as Treasury Secretary

The Private Equity Stakeholder Project likens Rowan to a fox guarding the hen-house, due to his position as CEO of Apollo Global Management. Rowan is being considered for a cabinet role in the incoming Trump administration.

FDA issues Class I recall on insertion tubes after manufacturing error

Specific FHC-branded insertion tubes used in brain surgery are 20mm longer than expected and could pose a serious risk to patients.

FDA recalls brain biopsy needles due to stainless steel debris

There have been no reported injuries. However, due to the risk of death or paralysis associated with metal debris entering brain tissue, the recall is designated Class I, the most serious of its type.

Michigan doctor claims he was fired for reporting unnecessary pacemaker surgeries

Daniel West, MD, is suing Trinity Health Muskegon and seeking whistleblower protection after reporting alleged malpractice and being summarily terminated.

FDA approves new short-term treatment for AFib, atrial flutter in critical care settings

Landiolol, sold by AOP Health under the brand name Rapiblyk, is an intravenous treatment designed to start working right away.

ACR, American Hospital Association urge Congress to create path for foreign-born docs to relieve shortages

Hospitals and physicians are pressing lawmakers to pass two previously proposed pieces of legislation that allow international medical graduates to work here longer.

Industry Watcher’s Digest

FDA commissioner Robert Califf recently suggested the agency may need to double its workforce. And that’s just to oversee AI.

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