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.

GE HealthCare Optison ultrasound enhancing agent

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.

Tariffs not enough to make Siemens Healthineers move production or raise prices—yet

The imaging manufacturer expects to spend between $227 million and $340 million on tariff mitigation efforts, leaders said Wednesday.

A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]

Answering key follow-up questions after the FDA approved TAVR in asymptomatic patients

The approval of certain TAVR valves to be used in asymptomatic patients is expected to make a significant impact on patient care going forward.

Tariffs will cost Philips Healthcare up to $340M

U.S.-China tariffs will have a $226M to $340M net impact on its bottom line in 2025, even after substantial mitigation efforts, the imaging manufacturer estimates.

Around the web

Health Imaging

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

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.