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 announces recall of Integra applicators due to sanitation risk
Multiple lots of extended tip applicators from Integra LifeSciences could put patients at risk of serious infection, prompting the FDA to designate the recall as Class I.
Recent fraud cases suggest ‘fake nursing’ has become a troubling career path
A new report reveals that states are keeping databases on “imposter nurses” to slow what could be a growing trend of unlicensed individuals holding nursing positions at hospitals nationwide.
Medtronic receives updated FDA approval for redo TAVR
The company also launched a new clinical trial designed to follow redo TAVR patients who present with symptomatic bioprosthetic valve failure for up to five years.
CDC director, chief medical officer ousted as RFK shakes up agency
CDC Director Susan Monarez, PhD, was less than a month into her role, having been confirmed by the U.S. Senate on July 30. Her lawyers said the staffing shakeup was a result of HHS Secretary Robert F. Kennedy Jr. “weaponizing public health for political gain.”
Under-reimbursement keeping radiologists from using key imaging modality, docs warn CMS
Radiologists and other physicians recently wrote to Administrator Mehmet Oz, MD, asking for changes related to contrast-enhanced ultrasound.

Technologists shouldn’t be alone when administering contrast for remote imaging scans, radiology groups say

One imaging policy expert called this stance from ACR and ASRT a “devastating blow” to physician offices and independent diagnostic testing facilities who use virtual supervision for Medicare patients.

WashU AI device earns FDA's Breakthrough Device designation.

'Revolutionary' AI risk assessment tool earns FDA's Breakthrough Device designation

The technology is said to be twice as accurate at predicting five-year cancer risk compared to current risk assessment methods.

Alan Matsumoto, MD, FSIR, FACR, FAHA, Chairman of Board for the American College of Radiology, professor of radiology and chair of the Department of Radiology, at the University of Virginia, explains ACR support for the Radiology Outpatient Ordering Transmission (ROOT) Act bill in Congress that calls for appropriate use criteria to be used instead of prior authorization.

ACR supports bringing back clinical decision support to combat prior authorizations

Alan Matsumoto, MD, chair of the American College of Radiology, explains ACR support for the Radiology Outpatient Ordering Transmission (ROOT) Act in Congress.

GE Healthcare's Venue Go point-of-care ultrasound (POCUS) system features AI-enabled tools to speed workflows, including Caption Guidance to help non-expert users capture diagnostic quality cardiac images. These systems helped drive positive earnings for the company in Q2 2025.

Despite tariffs, GE HealthCare sees sales growth in imaging systems and radiopharmaceuticals

Lower than expected tariff rates and the largest-ever order for Omni Legend PET/CT systems in the U.S. helped keep the bottom line positive.

FDA clears wearable heart device that captures multiple signals at once

The newly approved device captures electrocardiogram, photoplethysmogram and seismocardiogram signals at the same time. It can also be paired with advanced AI models to monitor patients for specific conditions.

Battle lines drawn as Kennedy mulls firing the USPSTF

By now the pleas for Kennedy to reconsider, initially sporadic, have gathered into a steady drumbeat.

Artificial heart developer gains key approval as money troubles continue

Carmat is working to overcome financial struggles that forced it to suspend new device implants through the end of August. Even with its future in limbo, the company remains focused on moving forward.

FDA announces Class I recall due to heart pump controller issue

The FDA previously shared an early alert about this issue, but it was still reviewing the situation at the time. The new recall covers a total of more than 11,000 devices.

Policy & Regulations

FDA announces recall of Integra applicators due to sanitation risk

Recent fraud cases suggest ‘fake nursing’ has become a troubling career path

Medtronic receives updated FDA approval for redo TAVR

CDC director, chief medical officer ousted as RFK shakes up agency

Under-reimbursement keeping radiologists from using key imaging modality, docs warn CMS