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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Recor Medical's Paradise Ultrasound Renal Denervation System

FDA panel votes in favor of Recor Medical renal denervation system

A few members of the panel did question the device's efficacy and long-term durability. The FDA will now use these findings to make its final decision related to the system's approval. 

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Lab owner gets 27 years in prison for $463M Medicare fraud scheme

According to the U.S. Department of Justice, LabSolutions took advantage of patients using a telemarketing scheme, with its owner personally pocketing millions in kickbacks.

FDA warning alert exclamation computer

FDA warning letter details quality concerns, violations at Integra facility

The facility in question is responsible for producing collagen-based medical devices primarily used in wound care, soft tissue repair and complex reconstruction surgeries. 

GE Healthcare's Portrait Mobile wireless and wearable monitoring solution

GE HealthCare earns FDA clearance for new remote patient monitoring device

The newly cleared device was designed with patient freedom and flexibility in mind. 

USA China artificial intelligence race

Race for AI dominance: 5 points to ponder about US v. China

AI that’s intended to let cars drive themselves can be repurposed to let tanks level cities. And AI can just as easily weaponize a virus as diagnose it. These are not secrets.

Biden administration invests $100M in strengthening nursing workforce

The funding is a response to the escalating demand for registered nurses, nurse practitioners, certified nurse midwives and nurse faculty throughout the United States. 

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FDA warns public not to use certain pregnancy tests due to safety, accuracy issues

The agency shared a list of 15 diagnostic tests that should not be used by patients going forward. 

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Interventional cardiologists call out ABIM for ‘unfair and unjustified’ certification policies

“This situation unacceptably exacerbates the interventional cardiology workforce shortage and threatens to directly impact the care of patients," SCAI wrote in a new statement. 

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Around the web

Cardiovascular Business
Q&A: MedAxiom CEO explores key trends in cardiologist, cardiovascular surgeon compensation

Compensation for heart specialists continues to climb. What does this say about cardiology as a whole? Could private equity's rising influence bring about change? We spoke to MedAxiom CEO Jerry Blackwell, MD, MBA, a veteran cardiologist himself, to learn more.

Cardiovascular Business
Payment cuts and beyond: Key takeaways for cardiologists from the 2025 Medicare Physician Fee Schedule

The American College of Cardiology has shared its perspective on new CMS payment policies, highlighting revenue concerns while providing key details for cardiologists and other cardiology professionals. 

AI in Healthcare
A modest proposal to rally AI regulators around a simple game plan

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”