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 clears new AI-enabled coronary plaque analysis software
Circle Cardiovascular Imaging, a Canadian medtech company, received the key approval for its cvi42 | Plaque platform.
Consolidation may be driving radiologists away from practicing as generalists
Radiologists who experienced a practice closure are more likely to operate as subspecialists afterward, according to new Neiman research.
FDA warns Philips after issues arise at multiple manufacturing facilities
Meanwhile, the Amsterdam-based imaging giant said it has already taken action to begin correcting these issues.
FDA accepts application for new Alzheimer’s PET imaging agent from Lantheus
The company is working to commercialize MK-6240, a radiodiagnostic that targets tau protein tangles—a “key hallmark of several neurodegenerative diseases.”
Medicare now covers renal denervation for patients with uncontrolled hypertension
This decision expands access to renal denervation to many more patients throughout the United States. Recor Medical and Medtronic both gained FDA approval for their RDN systems in 2023, and other vendors are actively developing their own treatment options.

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.

Industry Watcher’s Digest

Buzzworthy developments of the past few days.

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.

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.

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.

FDA announces another new recall involving Abbott’s HeartMate 3 LVADs after 70 injuries, 2 deaths

Abbott issued the new recall after receiving more than 80 reports of blood or air entering the LVAD during implant procedures. Customers can still use these devices, but they are advised to follow specific steps to limit the risk of complications.

Policy & Regulations

FDA clears new AI-enabled coronary plaque analysis software

Consolidation may be driving radiologists away from practicing as generalists

FDA warns Philips after issues arise at multiple manufacturing facilities

FDA accepts application for new Alzheimer’s PET imaging agent from Lantheus

Medicare now covers renal denervation for patients with uncontrolled hypertension