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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SCAI calls on interventional cardiologists to tell Washington to reverse physician pay cuts

Congress is considering two bills that would prevent or mitigate the Medicare physician payment cuts that went into effect in January 2024, and the Society for Cardiovascular Angiography and Interventions is urging members write their Congressmen.

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Nearly half of FDA cleared AI medical devices have not been validated on patient data

The FDA’s current draft guidance on the approval process for AI devices does not specify the type of validation the agency recommends manufacturers use. 

healthcare surprise billing statement payment

Radiologists ‘especially successful’ in surprise-billing disputes, notching payments 500% above QPA

UPDATED: Private equity-backed groups such as Rad Partners have dominated IDR use, with "little evidence" rank-and-file radiologists are using the system, experts wrote in Health Affairs. 

Prenuvo mobile whole-body MRI clinic

Startup Prenuvo to park ‘luxury’ whole-body MRI truck on Canadian border amid regulatory challenges

Despite amassing a wait list of 10,000 individuals, the company has confronted “significant barriers due to restrictions on private imaging services in Ontario.” 

mammography mammogram breast imaging

FDA issues guidance to help imaging providers comply with new mammography requirements

Beginning September 10, breast imaging facilities will be required to notify patients about the density of their breasts, among other regulatory changes. 

The U.S. Food and Drug Administration (FDA) has announced that Inari Medical is recalling its ClotTriever XL catheter for removing blood clots and other blockages from large blood vessels. The news comes after the FDA received several reports of “serious adverse events” due to the device becoming entrapped or blocking arteries in the patient’s lungs. Six deaths and four other patient injuries have been associated with the issue so far.

FDA announces recall of Inari Medical catheter after 6 deaths, 4 injuries

The FDA ruled that this is a Class I recall due to the significant risks for patients. Customers are not required to return the devices, however. Inari Medical has provided updated warnings and recommendations that should be followed. 

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'Game changer' prostate imaging agent granted FDA's Fast Track designation

The PET agent was developed for men with PSMA-positive lesions who have suspected metastasis and are candidates for initial definitive therapy.

The U.S. Food and Drug Administration (FDA) has announced that Defibtech, a Nihon Kohden company, is recalling its RMU-2000 ARM XR Chest Compression Device due to significant safety concerns. This is a Class I recall, which means the FDA believes using the device “may cause serious injury or death.”

Automated chest compression device recalled after patient death

Regulators emphasized that these devices should not be used due to significant safety risks. 

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