BETA
Manufacturer of MRI-guided focused-ultrasound systems, including the Exablate Neuro / Prime platform for specified movement-disorder treatments.
INSIGHTEC develops and manufactures MRI-guided focused-ultrasound equipment. Its current Exablate Neuro / Prime platform delivers targeted thermal ablation for specified movement-disorder indications under U.S. FDA PMA labeling.
Founded in 1999, the company identifies Tirat Carmel, Israel as its corporate headquarters and Miami, Florida as its U.S. headquarters. Maurice R. Ferré is CEO and chairman. Its wider Exablate regulatory history includes body applications and prostate-tissue ablation; these are distinguished from the current selected Neuro portfolio.
The company also supports research into additional neurological applications. Investigational uses are not interchangeable with approved movement-disorder indications, and FDA approval does not establish benefit for every proposed application.
The selected current Exablate Neuro / Prime family is covered by original PMA P150038 and subsequent supplements. The July 2025 S037 supplement includes specified unilateral and staged contralateral pallidothalamic-tractotomy use for eligible patients with idiopathic Parkinson’s disease. Supplements update labeling or manufacturing and are not additional original PMA approvals. [29][30][27]
The wider assembled FDA history contains three original PMAs and four 510(k) decisions, including body-treatment, prostate and coil lineages. Those non-Neuro records are retained but excluded from the current-family counts because current commercial availability of each configuration was not sufficiently established. Prostate-tissue ablation clearance is not a general U.S. prostate-cancer treatment claim. [1][5]
No matching FDA recall or device-enforcement event was identified in completed Insightec and Exablate searches. [4][3][8][7]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Thermal-ablation platform for specified essential-tremor and Parkinson’s-disease indications. Exact patient selection, targets, contraindications and staged-treatment requirements are governed by FDA labeling. [27][6][29][30]
FDA PMA approvedCurrent Neuro / Prime platform offered in the U.S. and other markets, subject to local indications
FDA history includes uterine-fibroid ablation and palliation of pain from metastatic bone cancer. Current commercial availability of each legacy body configuration was not established. [6]
Commercial availability not establishedCurrent availability not established for each legacy body configuration
FDA-cleared system for thermal ablation of prostate tissue. The U.S. tissue-ablation indication is not a blanket clearance for treatment of prostate cancer. [1]
Commercial availability not establishedCurrent routine availability was not established for every configuration
Historical Insightec Txsonics coil decisions retained separately from the current Neuro system. [1]
Commercial availability not establishedCurrent standalone availability not established
Publicly documented relationships; coverage may be incomplete.
| Partner | Territory / scope | Products |
|---|---|---|
| SYNEKTIK SA [26] | Listed distributor contact in Poland; contractual coverage not specified | INSIGHTEC systems; exact models not specified |
| SOFMEDICA [26] | Listed distributor contact in Romania; contractual coverage not specified | INSIGHTEC systems; exact models not specified |
| Vattikuti Technologies [26] | Listed distributor contact in India; contractual coverage not specified | INSIGHTEC systems; exact models not specified |
Sources checked October 20, 2026.
Accessed 10/29/2026