|Products||Exablate, Exablate Neuro|
The company's proprietary devices are called Exablate and Exablate Neuro, to treat indications in the body and the brain, respectively.
The company obtained premarket approval (PMA) from the Food and Drug Administration (FDA) in 2004 to market its Exablate system to treat uterine fibroids in women who did not intend to get pregnant again; and in 2015 it obtained a PMA to expand the marketing of the system to treat uterine fibroids in any woman. In 2012 the company obtained a PMA from the FDA to market the system to treat pain from metastatic bone cancer who had failed other treatments.
In 2012, the company received European CE mark for the treatment of neurological disorders in the brain including essential tremor, Parkinson's disease and neuropathic pain. It won approval to market the system for uterine fibroids in China in 2013.
In 2016, Insightec obtained a PMA from the FDA to market its Exablate Neuro system to treat essential tremor and the next month published data from the pivotal trial in the New England Journal of Medicine.
In 2016 the company hired Maurice R. Ferré, the founder and former CEO of Mako Surgical, as its CEO. Later that year the company signed an agreement with Siemens to integrate the device with Siemens' MRI systems.
- Tempany, Clare M. C.; McDannold, Nathan J.; Hynynen, Kullervo; Jolesz, Ferenc A. (April 2011). "Focused Ultrasound Surgery in Oncology: Overview and Principles". Radiology. 259 (1): 39–56. doi:10.1148/radiol.11100155. ISSN 0033-8419. PMC 3064817.
- "PMA P040003 (ExAblate) index page". FDA. October 22, 2004.
- Altman, Lawrence K. (23 November 2004). "Treating Troubling Fibroids Without Surgery". The New York Times.
- "PMA P040003 Supplement 15 (ExAblate) index page". FDA. August 31, 2015.
- "PMA P110039 (ExAblate) index page". FDA. October 18, 2012.
- "InSightec's ExAblate Neuro System Awarded European CE Mark for Non-invasive Treatment of Neurological Disorders in the Brain". www.prnewswire.com. Retrieved 2018-08-09.
- Garde, Damian (July 29, 2013). "InSightec takes to China with uterine fibroid device". FierceBiotech.
- "PMA P150038 (ExAblate Neuro) index page". FDA. July 11, 2016.
- Al Idrus, Amirah (August 24, 2016). "Pivotal data for Insightec's noninvasive essential tremor device published in NEJM". FierceBiotech.
- Lawrence, Stacy (January 8, 2016). "Insightec raises $22M, brings on Mako Surgical co-founder as CEO". FierceBiotech.
- Al Idrus, Amirah (August 15, 2016). "Siemens, Insightec partner on novel essential tremor treatment". FierceBiotech.