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. 

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4 points crucial to the nimble regulation of GenAI

With generative AI coming into its own, AI regulators must avoid relying too much on principles of risk management—and not enough on those of uncertainty management.

FDA recalls infant incubators due to risk of door falling off

A loose screw on the Giraffe OmniBed is to blame. With updated use instructions and repairs, the incubators are safe to use. 

‘A huge win’: CMS significantly increases Medicare payments for cardiac CT

CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.

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Kentucky AG launches criminal probe after conscious man nearly has organs harvested

Three years ago Anthony Hoover was declared brain dead—until he woke up on the operating room table, moments before his organs were removed. His story has spurred a criminal investigation by Kentucky's attorney general.

the words "FDA recall" on a board

FDA announces Class I recall of ventilators after 3 patient injuries

An unexpected nickel coating on the breathing circuits of Percussionaire Phasitron 5 ventilators is being blamed for the recall. The FDA is asking providers to stop using them immediately. 

HeartLung Technologies, a Houston-based artificial intelligence (AI) company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for new software that assesses chest CT scans for signs of coronary artery disease (CAD) and other potentially fatal heart conditions. The newly cleared offering, AutoChamber, was designed with opportunistic heart evaluations in mind.

FDA clears AI tool that flags signs of heart disease in chest CT scans

The newly cleared offering, AutoChamber, was designed with opportunistic screening in mind. It can evaluate many different kinds of CT images, including those originally gathered to screen patients for lung cancer. 

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Stewardship Health sale to private equity finalized for $245M

The physician group, once part of Steward Health Care, has been rebranded as Revere Medical.

Helene damage to bridge Baxter North Cove facility in North Carolina.

Baxter producing IV solutions ahead of schedule at Asheville-area site

The company said its largest production line at its North Carolina plant is operational, accounting for 25% of total output. The site was damaged by flood waters from Hurricane Helene. 

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Around the web

AI in Healthcare
4 points crucial to the nimble regulation of GenAI

With generative AI coming into its own, AI regulators must avoid relying too much on principles of risk management—and not enough on those of uncertainty management.

Cardiovascular Business
Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

Cardiovascular Business
Cardiologist compensation still rising, especially in invasive and interventional cardiology

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.

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