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