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 accepts previously rejected application for new PET imaging agent
Radiopharma firm Telix hopes to soon begin selling Pixclara (Floretyrosine F 18), an investigational product for glioma, a type of brain cancer.
States’ challenge against HHS staffing cuts, restructuring moves forward
The coalition of plaintiffs—representing 19 states and Washington, D.C.—is challenging many of the changes made by Elon Musk’s Department of Government Efficiency, which has since halted operations. State governments argue that HHS is no longer performing its constitutionally required duties. The agency’s attempt to dismiss the lawsuit was rejected this week.
Healthcare in the midterms: A look ahead to decision day
Will healthcare be the top issue voters take into the polls come November? KFF looks at the odds of the economy falling into second place this year.
FDA denies petition to exempt certain radiology AI devices from premarket review
In October, Harrison.ai submitted a citizen petition seeking greater flexibility in the 520(k) clearance process for certain computer-aided detection devices.
Dying former US senator: ‘Will AI bring heaven or hell? Yes.’
Ben Sasse is showing the effects of the terminal pancreatic cancer he was diagnosed with late last year. Yet he’s still in good spirits and his mental energy remains high.

FDA clears ultrasound AI tool for accurate delivery-date prediction

The cloud-based software service is able to predict a pregnant woman's delivery date using ultrasound imaging alone.

SCAI celebrates new federal funding for PAD prevention

The group's hope is that these new funds will help address the rising rates of PAD and CLTI throughout the United States.

FDA recall medical device recall product recall

FDA confirms more recalls for Johnson & Johnson heart pumps due to malfunction risk

The issue, first announced to the public in February, has been linked to 22 serious injuries. Customers are urged to review the updated instructions for use to avoid any potential complications.

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Radiology artificial intelligence firm asks FDA to exempt certain devices from premarket review

The petition from Harrison.ai has drawn mixed reactions, with AI vendors lending support while radiologists and patient groups worry the move could erode safety.

AHA: ‘Zero trust’ cybersecurity posture necessary to protect hospital data

The National Security Agency released a two-phase plan for all entities within the U.S. Department of War to follow for no-trust cyber defenses. The American Hospital Association said the protocols could be adopted by hospitals.

doctor comparing the costs of different medical treatments

Hospitals accounted for 40% of spike in healthcare spending, far more than any other category: KFF

The study by the nonprofit KFF is focused on the jump in overall healthcare prices from 2022 to 2024, with hospitals leading as a result of both delayed care from the pandemic and an increase in prices for services.

Abbott has secured U.S. Food and Drug Administration (FDA) approval for its CardioMEMS HERO device, a next-generation pulmonary artery (PA) pressure reader for heart failure patients.

FDA approves next-generation CardioMEMS reader for heart failure monitoring

The updated reader is 60% smaller and offers built-in WiFi connectivity. It works with an implantable sensor to monitor a patient's PA pressure.

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American College of Radiology urges HHS to address ‘unsustainable’ AI payment policy

ACR recently voiced its frustrations to Health and Human Services, sharing suggestions for how the agency could spur greater use of this technology.

Policy & Regulations

FDA accepts previously rejected application for new PET imaging agent

States’ challenge against HHS staffing cuts, restructuring moves forward

Healthcare in the midterms: A look ahead to decision day

FDA denies petition to exempt certain radiology AI devices from premarket review

Dying former US senator: ‘Will AI bring heaven or hell? Yes.’