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 popular ultrasound enhancing agent for pediatric patients
Unlike other UEA options, GE HealthCare's Optison does not contain polyethylene glycol. The FDA approved its used for adult patients back in 1997.
FDA gives AI-powered blood test for obstructive CAD breakthrough device designation
The FDA clearly sees significant potential in a new multi-protein blood test from Prevencio. The company's goal is to gain full approval and get the test in the hands emergency departments all over the United States.
ASNC, ACC ask US government not to tariff radiopharmaceuticals
The two groups stressed that tariffs would likely impact patient care.
Tariffs will have a significant impact on the nuclear imaging supply chain in the US
"Domestic radiopharmaceutical suppliers, who receive isotopes from abroad, would be impacted by price changes and uncertainty caused by additional tariffs,” SNMMI President Cathy Cutler, PhD, wrote in a letter to the U.S. Department of Commerce this week.
U.S. iodine contrast supply may not be subject to proposed 25% tariffs
If President Trump initiates a 25% tariff against pharmaceuticals imported from Ireland, it might impact the price for X-ray iodine contrast agents in the U.S. depending what rules are put in place.

The impact of Trump tariffs on iodine contrast media costs

GE HealthCare said the price of iodine contrast increased by more than 200% between 2017 to 2023. Will new Chinese tariffs drive costs even higher?

ACC President Cathie Biga explains the American College of Cardiology advocacy efforts in Washington D.C. in 2025.

ACC president details key advocacy efforts in cardiology

American College of Cardiology President Cathie Biga, MSN, says Medicare payment reform remains a top priority going forward. Site-neutral payments and improved access to PAD screening are two other issues close to the ACC's heart.

Benzodiazepine use before heart surgery: Should it be embraced or restricted?

Benzodiazepines are administered before a majority of cardiac surgeries to lower the risk of intraoperative awareness. At the same time, however, recent studies have suggested they increase the risk of postoperative delirium.

The U.S. Food and Drug Administration (FDA) has shared a new warning about ongoing safety issues with atherectomy devices sold and distributed by Bard Peripheral Vascular, an Arizona-based subsidiary of Becton, Dickinson and Company (BD). The warning includes multiple models of Bard Peripheral Vascular’s Rotarex Atherectomy System, which is designed to target high-risk plaques and blood clots in the peripheral arteries by rotating at a high speed.

FDA warns that atherectomy devices are breaking during use—30 serious injuries, 4 deaths reported

More than 100 incidents have been reported so far. The FDA is still evaluating this issue, but the agency wanted to raise awareness as quickly as possible.

FDA warns that smartphone-compatible diabetes devices may not work properly

Smartphones have made it easier than ever for patients to monitor their own health, but the technology is far from infallible.

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Cardiologist-supported bill to stop ‘harmful’ Medicare cuts returns to Congress

A bipartisan bill designed to block recent Medicare payment cuts has been reintroduced to Congress after failing to pass in 2024. Will things be any different this time around?

Swedish total artificial heart tech granted FDA’s humanitarian use designation

Realheart celebrated the news, noting that multiple preclinical trials focused on the technology's safety and effectiveness are currently underway.

Blood pressure drug recalled due to black contaminants—FDA highlights safety risks

The recall was put in place after a customer discovered “visible black particulate matter” in a sealed vial. If the contaminant enters a patient's blood vessels, it could lead to serious complications, including a stroke or even death.

Around the web

Health Imaging

Tariffs will have a significant impact on the nuclear imaging supply chain in the US

"Domestic radiopharmaceutical suppliers, who receive isotopes from abroad, would be impacted by price changes and uncertainty caused by additional tariffs,” SNMMI President Cathy Cutler, PhD, wrote in a letter to the U.S. Department of Commerce this week.

Radiology Business

U.S. iodine contrast supply may not be subject to proposed 25% tariffs

If President Trump initiates a 25% tariff against pharmaceuticals imported from Ireland, it might impact the price for X-ray iodine contrast agents in the U.S. depending what rules are put in place.