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.

Massive spending bill passes final vote in Congress with Medicaid cuts intact
The 940-page document passed the House of Representatives in a 218 to 214 vote, and now heads to President Donald Trump’s desk. It contains a 20% cut to federal Medicaid funding, something Trump said he opposes.
Radiation in the cath lab: Tracking state-level regulations for cardiologists
Researchers hope these policies can be standardized in the future to help avoid confusion and improve clinician safety.
Doc groups say payer promises not enough to address care denials
MGMA and others who are part of the “Regulatory Relief Coalition” are urging Congress to continue pushing forward with the Improving Seniors’ Timely Access to Care Act.
Russian researcher strategizes on collaboration with China over healthcare AI
Have you ever wondered what China and Russia would talk about if they were to discuss AI in healthcare? It turns out they do just that—and a newly published academic paper straight out of the Russian Federation offers a glimpse into the dialogue.
10-second brain MRI scans possible with newly FDA-cleared deep learning reconstruction software
The artificial intelligence-enabled software offers accelerated acquisition times, improved image resolution and one-click workflows for technologists.

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.”

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.

'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.

CMS has received 12,000 complaints over No Surprises Act noncompliance—most were valid

In total, 10,300 complaints were made against providers and air ambulance services. The rest were for surprise bills from insurance plans.

Dana Smetherman, MD, explains the ACR take on the growing radiology staffing shortage.

Radiology workforce shortage a major concern for the American College of Radiology

Dana H. Smetherman, MD, MBA, CEO of the ACR, discusses the reasons behind the worsening shortage of radiologists, along with possible solutions.

AISAP, an Israeli healthcare technology company focused on using artificial intelligence (AI) to enhance medical imaging results, has gained U.S. Food and Drug Administration (FDA) clearance for its new point-of-care ultrasound (POCUS) software platform, AISAP Cardio.

FDA clears AI-powered POCUS platform for structural heart disease, heart failure

The cloud-based platform was designed to help even inexperienced users scan and diagnose a majority of common heart issues within minutes without leaving the patient’s side.

Policy & Regulations

Massive spending bill passes final vote in Congress with Medicaid cuts intact

Radiation in the cath lab: Tracking state-level regulations for cardiologists

Doc groups say payer promises not enough to address care denials

Russian researcher strategizes on collaboration with China over healthcare AI

10-second brain MRI scans possible with newly FDA-cleared deep learning reconstruction software