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. 

cardiologist viewing heart data

Cardiologists examine how residual TR after transcatheter tricuspid valve repair impacts survival

Researchers tracked data from more than 600 patients, noting that heart teams may want to reconsider how they classify residual TR after treatment. 

Atraverse Medical Hotwire radiofrequency (RF) guidewire

Medical device startup gains FDA clearance for new RF guidewire, raises $12.5M

Atraverse Medical, a San Diego-based medical device company founded in 2022, designed the guidewire to give physicians as much freedom as possible while treating heart patients. 

Congress dome capitol Washington

Industry Watcher’s Digest

Buzzworthy developments of the past few days.

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Radvocates applaud bipartisan bill that would end decade-long decline in Medicare reimbursement

The Radiation Oncology Case Rate Value-Based Program Act of 2024 would build on the shelved RO Model and save the federal payment program $200M. 

bipartisan house task force on artificial intelligence

About that bipartisan $32B ‘roadmap’ for AI policy: What’s in it for healthcare?

This week Washington took a major step toward nailing down a solid game plan on federal AI spending for everything outside of defense.

4C Medical Technologies AltaValve

FDA grants breakthrough device designation to new TMVR device from 4C Medical

The supra-annular AltaValve System was designed to treat both primary and secondary mitral regurgitation. It is implanted via transseptal access and positioned above the native mitral valve.

MDMA Ecstasy

FDA set to evaluate use of ‘ecstasy’ for treating PTSD

The party drug could soon be prescribed, in conjunction with psychological interventions, as a treatment for mental health disorders.

Profound Medical prostate ablation contouring assistant

Prostate ablation AI 'contouring assistant' lands FDA clearance

The new module is a machine learning-based segmentation tool that further enhances procedural planning.