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. 

private equity corporatization business consolidation

Steward sells physician group to private equity firm for $245M

Stewardship Health, a group represented by 3,500 doctors, will be sold to Rural Healthcare Group, owned by private equity firm Kinderhook Industries.

Tandem Diabetes Care is recalling a recent update of the mobile app for its t:slim X2 insulin pump due to repeated software issues that may cause the pump to shut down unexpectedly. The FDA has said this is a Class I recall.

Patient risks persist for insulin pump caught in Class I recall

A software update for the pump's mobile app was expected to fix ongoing battery issues, but the problem remains. 

M&A mergers and acquisitions business deal

Steward reaches deal to sell multispecialty physician group to private equity affiliate for $245M

The deal includes Steward Medical Group, a physician-led organization offering primary care, diagnostic imaging and other specialty services across several states. 

Medicare money payment reimbursement dollar decline george washington

Proposed Medicare cut will reduce RadNet’s revenues by upward of $8M in 2025

"Our experts believe there’s a high probability that the final rule governing next year's Medicare payments will be less severe than the current proposal," CFO Mark Stolper told investors.  

Siemens Healthineers has gained U.S. Food and Drug Administration (FDA) clearance for Acuson Origin, its new cardiovascular ultrasound system featuring advanced artificial intelligence (AI) capabilities. The Acuson Origin represents a significant update from the prior Siemens Healthineers cardiovascular ultrasound system, the Acuson SC2000.

Siemens Healthineers' new AI-enabled cardiovascular ultrasound system granted FDA clearance

The system integrates a slew of AI powered imaging features that have been trained on more than 2 billion annotated images. 

Artificial intelligence sign in the United Imaging booth. The Chinese company wants to break into the U.S. market and has a massive booth footprint at RSNA 2023. This included a section for its own AI development division. Photo by Dave Fornell #RSNA

FDA on track to clear 1,000+ clinical AI algorithms by end of the year

As of July 2024, the FDA reports it has cleared 950 AI algorithms to aid in direct clinical decision making.

Siemens Healthineers has gained U.S. Food and Drug Administration (FDA) clearance for Acuson Origin, its new cardiovascular ultrasound system featuring advanced artificial intelligence (AI) capabilities. The Acuson Origin represents a significant update from the prior Siemens Healthineers cardiovascular ultrasound system, the Acuson SC2000.

Siemens Healthineers gains FDA clearance for new AI-powered cardiovascular ultrasound system

The Acuson Origin system includes advanced AI algorithms designed to assist users with the treatment of diagnostic, structural heart, vascular, electrophysiological and pediatric patients. It also comes packaged with a new 4D ICE catheter capable of multiplanar reconstruction imaging with or without the use of an electrocardiogram.

Dana Smetherman, MD, ACR CEO, explains AUC may be better than prior authorizations.

ACR CEO discusses solution to fight burdensome prior authorizations in medical imaging

Dana Smetherman, MD, MBA, outlines a possible remedy for the growing number of these roadblocks in the specialty.