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. 

claire perimeter medical imaging

FDA approves 1st AI-enabled imaging device for breast cancer surgery

Manufacturer Perimeter Medical Imaging announced the news on March 3 after earning premarket approval for “Claire” (formerly the Perimeter OCT B-Series). 

Bayer's MR contrast injection system cleared by FDA for expanded use

The updated clearance expands the system's labeled field strength compatibility; the change will allow MRI suites with scanners up to the 7T range to utilize the system.

Network peer to peer P2P learning web communication interoperability

Clover Health becomes first healthcare payer to meet CMS interoperability standard

Meeting the requirements to become a CMS Aligned Network means medical records on its core Medicare Advantage patients will be made available in real-time upon request, facilitated through secure data exchange made possible by Kno2.

money maze payment reimbursement

AI-enabled lesion quantification tool earns new CPT code

The software gives clinicians detailed insight into how patients are responding to treatment based on changes in lesion size and metabolic activity, offering earlier opportunities to alter care plans.  

artificial intelligence AI in healthcare

Cardiologist surrenders medical license after faking penile cancer diagnosis

An interventional cardiologist has lost his ability to practice in multiple states after faking a cancer diagnosis, lying about his training and allegedly asking a colleague to falsify documents. 

Medicare money bills dollars

Radiology societies fight Medicare Administrative Contractor’s proposed coverage restriction

National Government Services is seeking to limit the use of thermal destruction of the intraosseous basivertebral nerve, aka the Intracept procedure, drawing ire from ACR and SIR. 

artificial intelligence AI policy washington capitol

HHS tells employees to abandon Claude AI, as Trump feuds with developer Anthropic

The outlet NOTUS was the first to break the news, citing an internal email it obtained written by government officials. Agencies under the Department of Health and Human Services have been told to seek alternatives, mainly ChatGPT or Gemini. The shift could throw a wrench in the FDA’s plans to use Claude for speedy drug approvals. 

Farapulse Boston Scientific Pulsed Field Ablation PFA fda approval

Boston Scientific’s Farapulse PFA system receives expanded approval

The technology first gained CE mark approval for the treatment of paroxysmal AFib in 2021, when PFA was still brand new. Now, thanks to positive results from the ADVANTAGE AF clinical trial, it is approved for persistent AFib as well.