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 takes first step toward ending animal testing as part of ‘3.0 modernization'
Monoclonal antibody therapies will be the first drugs permitted to take advantage of alternatives, including advanced lab simulations and artificial intelligence. A pilot framework to phase out the decades-long requirement for animal testing will be rolled out in the coming year, the FDA said.
Opportunistic screening tool for osteoporosis nabs FDA clearance
The algorithm can be applied to noncontrast abdominal CT scans completed for any clinical indication.
Radiology M&A expert shares 6 trends to watch in 2025
Andrew Colbert, senior managing director of Ziegler, spoke at RBMA 2025, discussing teleradiology's "explosive" growth, among other developments.
Members of Congress propose faster Medicare payment pathway for imaging AI
The Health Tech Investment Act will place all FDA-approved AI devices into the Hospital Outpatient Prospective Payment System for a minimum of five years.
Radiology practice will pay $350,000 for allegedly violating HIPAA Rule prior to cyberattack
HHS charges that New York state-based Northeast Radiology failed to conduct a thorough risk analysis of its systems, which may have prevented the PACS breach.

Video of ASE lobbyists explaining issues with Medicare funding policy reform in Washington DC.

Key government policies impacting cardiac ultrasound

Two experienced lobbyists who represent the American Society of Echocardiography detailed some of the biggest issues they are working on in Washington.

FDA warning letter details quality concerns, violations at Integra facility

The facility in question is responsible for producing collagen-based medical devices primarily used in wound care, soft tissue repair and complex reconstruction surgeries.

GE Healthcare's Portrait Mobile wireless and wearable monitoring solution

GE HealthCare earns FDA clearance for new remote patient monitoring device

The newly cleared device was designed with patient freedom and flexibility in mind.

Abiomed recalls heart pump catheter labeling after 12 injuries

This is a Class I recall, which means using the devices “may cause serious injuries or death.” The catheter's instructions have been updated to reduce the risk of complications going forward.

Imaging vendor Nanox says it will pay $650,000 in civil penalties to settle SEC investigation

The Israel-based company said it also has entered an agreement to settle a class action lawsuit for another $8 million.

FDA announces yet another recall, the fifth of 2023, for troubled heart devices

The latest Class I recall is due to mechanical issues that can cause the devices to stop charging their batteries.

Race for AI dominance: 5 points to ponder about US v. China

AI that’s intended to let cars drive themselves can be repurposed to let tanks level cities. And AI can just as easily weaponize a virus as diagnose it. These are not secrets.

Fearing delays, American College of Radiology urges CMS not to leave PET payment decisions up to MACs

ACR is concerned such a scenario would result in delayed and highly variable coverage determinations across the U.S.

Policy & Regulations

FDA takes first step toward ending animal testing as part of ‘3.0 modernization'

Opportunistic screening tool for osteoporosis nabs FDA clearance

Radiology M&A expert shares 6 trends to watch in 2025

Members of Congress propose faster Medicare payment pathway for imaging AI

Radiology practice will pay $350,000 for allegedly violating HIPAA Rule prior to cyberattack