Diseases and Conditions
Focused ultrasound is a platform technology that is transforming 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.
Status by disease category
The majority of the indications are early stage.
Focused ultrasound treatment for uterine fibroids has been available to women in the US since a treatment system was approved by the Food and Drug Administration (FDA) in 2004. The technology was approved in the US 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. In July 2016, the FDA approved Insightec’s Exablate Neuro device to treat essential tremor. The same device was approved to treat tremor-dominant Parkinson’s disease in December 2018, and this approval was extended to Parkinson’s dyskinesia in November 2021. In December 2020, the FDA approved Profound Medical’s Sonalleve MR-guided high-intensity focused ultrasound system under a Humanitarian Device Exemption (“HDE”) to treat osteoid osteomas in the extremities.
This information is provided by the manufacturers. It is correct to the best of our knowledge.