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. 

Doctor patient with masks

Should masks still be required at hospitals? Physicians push for a nuanced approach in face of uncertainty

A team of physicians examined the question of continued masking, urging healthcare leaders to work together in a new commentary in Annals of Internal Medicine.

August 24, 2023
The U.S. Food and Drug Administration (FDA) has approved Recor Medical’s Paradise Ultrasound Renal Denervation (RDN) system for uncontrolled hypertension. The Recor system gained FDA clearance in November 2023.

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. 

August 23, 2023

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.

August 21, 2023
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. 

August 18, 2023
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. 

August 18, 2023
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.

August 17, 2023
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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. 

August 15, 2023

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. 

August 15, 2023

Around the web

The recall includes specific lots of five different medical devices used to treat stroke and other neurovascular diseases.

The agency is urging healthcare providers to transition away from these devices and seek out alternatives. It is even working with other manufacturers to try and get similar products on the market as quickly as possible. 

Jeffrey Kuvin, MD, one of the leading voices behind efforts to create a new Board of Cardiovascular Medicine, spoke with Cardiovascular Business about where things stand today.

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