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 approves JenaValve TAVR system for aortic regurgitation
The Trilogy Transcatheter Heart Valve System is the first TAVR device approved by the FDA to treat severe aortic regurgitation. Until now, interventional cardiologists have had to settle for the off-label use of TAVR valves built for treating aortic stenosis.
Bipartisan bill would exempt radiologists from new $100,000 visa fee
The bill is endorsed by the American Medical Association, American Hospital Association and numerous others in the industry.
Insurer and business lobbying interests kill supplemental breast imaging bill in 1 state
Earlier this year, Kansas lawmakers introduced Senate Bill 409, seeking to close insurance gaps for women who need follow-up scans after screening mammography.
ACIP meeting postponed after judge pauses RFK’s new vaccine recommendations
Judge Brian Murphy with the U.S. District Court of Massachusetts sided with the American Academy of Pediatrics and other plaintiffs who challenged the authority of HHS Secretary Robert F. Kennedy Jr to effectively remove the Advisory Committee on Immunization Practices from the process put in place to make changes to CDC vaccine recommendations.
'Cybersecurity vulnerability' spurs FDA recall of GE HealthCare image viewers
The recall is due to an issue with the software that could make the viewer vulnerable to security threats and data manipulation.

FDA approves JenaValve TAVR system for aortic regurgitation

The Trilogy Transcatheter Heart Valve System is the first TAVR device approved by the FDA to treat severe aortic regurgitation. Until now, interventional cardiologists have had to settle for the off-label use of TAVR valves built for treating aortic stenosis.

Bipartisan bill would exempt radiologists from new $100,000 visa fee

The bill is endorsed by the American Medical Association, American Hospital Association and numerous others in the industry.

Insurer and business lobbying interests kill supplemental breast imaging bill in 1 state

Earlier this year, Kansas lawmakers introduced Senate Bill 409, seeking to close insurance gaps for women who need follow-up scans after screening mammography.

ACIP meeting postponed after judge pauses RFK’s new vaccine recommendations

Judge Brian Murphy with the U.S. District Court of Massachusetts sided with the American Academy of Pediatrics and other plaintiffs who challenged the authority of HHS Secretary Robert F. Kennedy Jr to effectively remove the Advisory Committee on Immunization Practices from the process put in place to make changes to CDC vaccine recommendations.

'Cybersecurity vulnerability' spurs FDA recall of GE HealthCare image viewers

The recall is due to an issue with the software that could make the viewer vulnerable to security threats and data manipulation.

Radiologists support bipartisan bill to fund new residency programs in rural areas

The American College of Radiology, alongside over 30 other organizations, voiced “strong support” for the bill on March 16.

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Telix submits new brain imaging agent for FDA review following previous rejection

The Australia-based company has resubmitted its New Drug Application for Pixclara, an investigational PET product.

Telehealth company admits to sharing medical records with law firms as Epic’s lawsuit heats up

GuardDog admitted to accessing medical histories from patients stored on Epic’s platform, selling some of them to law firms engaged in unrelated civil litigation. The primary defendant in Epic’s lawsuit, Health Gorilla, maintains it did nothing wrong and accuses Epic of stifling interoperability.