Overview

Focused ultrasound is a platform technology that has the potential to transform the treatment of a variety of medical conditions.

There is a large and growing number of clinical applications for focused ultrasound that are in various stages of research, development and commercialization.

Rainbow Sept2016

The majority of the indications are early stage, with none yet receiving universal insurance reimbursement

Rainbow by adoption 10 2016 

Focused ultrasound treatment for uterine fibroids has been available to women in the U.S. since a treatment system was approved by the Food and Drug Administration (FDA) in 2004. The technology was approved in the U.S. in 2012 for the relief of pain associated with cancer that has spread to the bone. Two focused ultrasound systems were FDA approved for the ablation of prostate tissue in 2015. 

Regulatory Approvals by Region

Medical Condition United States Canada Europe Asia Latin America Middle East
Cancer
Bone Metastases  ✓
Breast Cancer        
Kidney Cancer        
Liver Cancer        
Pancreatic Cancer        
Prostate Cancer ✓*  ✓  ✓  ✓   
Soft Tissue Sarcoma     ✓     
Endocrine Disorders  
Thyroid Nodules          
Pain Relief
Back Pain          
Osteoid Osteoma          
Brain Disorders
Essential Tremor          
Neuropathic Pain          
Parkinsonian Tremor          
Women's Health
Adenomyosis          
Breast Fibroadenoma          
Uterine Fibroids

This information is provided by the manufacturers. It is correct to the best of our knowledge.
*The FDA approved two devices in 2015 that could be used to treat prostate diseases including cancer and BPH. 

 

     

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