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.

AI newswatch: Lifecyle AI oversight, data matters, AI vs. animals, more
AI may finally end the paper chase caused by prior authorization. Or it may worsen it.
Leaked HHS budget reveals 30% cuts, elimination of many core services
A proposal for the massive restructuring of the Department of Health and Human Services ends funding to programs associated with chronic disease management, lead safety, and Head Start. However, HHS is adding a new department to focus on understanding the cause of long-term illness.
Cardiologist-founded startup announces FDA clearance, first uses of new TAVR pacing system
“The device takes variability out of the procedure by giving the operator full control while automating ramp-up and back-up algorithms," according to a clinician who used the new technology. "The TAVR procedure is simplified, reducing physician and staff workload."
AI has come a long way in healthcare, still has a long way to go: Research recap
As AI continues its march through healthcare organizations around the world, the notion that it will replace the sector’s human workers fades but does not disappear.
UnitedHealth, Amedisys enter mediation with DOJ over block on $3.3B merger
The two companies have been unable to assuage antitrust concerns raised by the Department of Justice. A magistrate will attempt to hammer out acceptable terms for the home healthcare merger at a conference scheduled for August.

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 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.

FDA rejects ‘ecstasy’ as treatment for PTSD

The agency has asked for an additional phase 3 study before it considers another application from manufacturer Lykos.

Recor Medical's Paradise Ultrasound Renal Denervation System

CMS increases inpatient payment for Recor Medical, Medtronic renal denervation systems

Physicians using the Paradise Ultrasound Renal Denervation system from Recor Medical or Symplicity Spyral Renal Denervation system from Medtronic will soon be eligible for a much more significant reimbursement when treating Medicare patients in an inpatient setting.

FDA adds dozens of AI-enabled radiology applications to list of clearances

Around two-thirds of all approved artificial intelligence-powered clinical devices are catered to radiology settings.

Policy & Regulations

AI newswatch: Lifecyle AI oversight, data matters, AI vs. animals, more

Leaked HHS budget reveals 30% cuts, elimination of many core services

Cardiologist-founded startup announces FDA clearance, first uses of new TAVR pacing system

AI has come a long way in healthcare, still has a long way to go: Research recap

UnitedHealth, Amedisys enter mediation with DOJ over block on $3.3B merger