# Insightec

> Mediated Wiki article. Canonical URL: https://mediated.wiki/source/Insightec
> Markdown URL: https://mediated.wiki/source/Insightec.md
> Source: https://en.wikipedia.org/wiki/Insightec
> Source revision: 1356610991
> License: Creative Commons Attribution-ShareAlike 4.0 International (https://creativecommons.org/licenses/by-sa/4.0/)

Medical device company

INSIGHTEC Ltd. Type Private Industry Medical devices Founded 1999; 27 years ago (1999) Headquarters Tirat Carmel , Israel Area served Worldwide Products Exablate, Exablate Neuro Website Insightec.com

**INSIGHTEC Ltd.**, is an [Israeli](/source/Israel) privately held medical device company that sells [MR guided Focused Ultrasound](/source/High-intensity_focused_ultrasound) equipment. The technology can destroy deep tissue in the body without the need for incisions.[1] Clinical use of the technology has been reported to reduce tremor symptoms in patients with [essential tremor](/source/Essential_tremor) and [Parkinson’s disease](/source/Parkinson%E2%80%99s_disease).[2]

The company is headquartered in [Tirat Carmel](/source/Tirat_Carmel), and maintains offices in [Dallas](/source/Dallas), [Miami](/source/Miami), [Tokyo](/source/Tokyo), and [Shanghai](/source/Shanghai).[3] As of 2019, its technology had been used in more than 50 medical centres worldwide, with over 2,000 patients treated.[3]

## History

The company was founded in 1999[3] by Kobi Vortman and Oded Tamir, with seed investment from [Elbit Medical Imaging](/source/Elbit_Medical_Imaging) and [GE Healthcare](/source/GE_Healthcare).[*[citation needed](https://en.wikipedia.org/wiki/Wikipedia:Citation_needed)*]

The company obtained [premarket approval](/source/Federal_Food%2C_Drug%2C_and_Cosmetic_Act#Premarket_approval_.28PMA.29) (PMA) from the [Food and Drug Administration](/source/Food_and_Drug_Administration) (FDA) in 2004 to market its Exablate system to treat [uterine fibroids](/source/Uterine_fibroids) in women who did not intend to get pregnant again;[4][5] and in 2015 it obtained a PMA to expand the marketing of the system to treat uterine fibroids in any woman.[6] 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.[7]

In 2011, the company's work was featured in [TEDMED](/source/TEDMED) by Yoav Medan, chief systems architect.[8]

In 2012, the company received European [CE mark](/source/CE_mark) for the treatment of neurological disorders in the brain including essential tremor, Parkinson's disease and neuropathic pain.[9] It won approval to market the system for uterine [fibroids](/source/Fibroin) in China in 2013.[10]

In 2016, Insightec obtained a PMA from the FDA to market its Exablate Neuro system to treat [essential tremor](/source/Essential_tremor),[11] and the next month published data from the pivotal trial in the *New England Journal of Medicine*.[12]

In 2016, the company hired [Maurice R. Ferré](https://en.wikipedia.org/w/index.php?title=Maurice_R._Ferr%C3%A9&action=edit&redlink=1), the founder and former CEO of [Mako Surgical](/source/MAKO_Surgical_Corp.), as its CEO.[13] Later that year, the company signed an agreement with [Siemens](/source/Siemens) to integrate the device with Siemens' MRI systems.[14]

The company also received additional FDA approval in 2018 for its focused ultrasound technology.[3]

## References

1. **[^](#cite_ref-1)** Tempany, Clare M. C.; McDannold, Nathan J.; Hynynen, Kullervo; Jolesz, Ferenc A. (April 2011). ["Focused Ultrasound Surgery in Oncology: Overview and Principles"](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3064817). *Radiology*. **259** (1): 39–56. [doi](/source/Doi_(identifier)):[10.1148/radiol.11100155](https://doi.org/10.1148%2Fradiol.11100155). [ISSN](/source/ISSN_(identifier)) [0033-8419](https://search.worldcat.org/issn/0033-8419). [PMC](/source/PMC_(identifier)) [3064817](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3064817). [PMID](/source/PMID_(identifier)) [21436096](https://pubmed.ncbi.nlm.nih.gov/21436096).

1. **[^](#cite_ref-2)** Shoshanna Solomon (2020-02-19). ["This Israeli tech helped 'grandpa' stop spilling his drink"](https://www.timesofisrael.com/this-israeli-tech-helped-grandpa-stop-spilling-his-drink/). *The Times of Israel*. Retrieved 2025-04-26.

1. ^ [***a***](#cite_ref-Maccioni_3-0) [***b***](#cite_ref-Maccioni_3-1) [***c***](#cite_ref-Maccioni_3-2) [***d***](#cite_ref-Maccioni_3-3) Federico Maccioni (2019-05-05). ["Israeli startup uses ultrasound waves to reduce Parkinson's tremors"](https://www.timesofisrael.com/israeli-startup-uses-ultrasound-waves-to-reduce-parkinsons-tremors/). *The Times of Israel*. Retrieved 2025-04-26.

1. **[^](#cite_ref-4)** ["PMA P040003 (ExAblate) index page"](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040003). FDA. October 22, 2004.[*[dead link](https://en.wikipedia.org/wiki/Wikipedia:Link_rot)*]

1. **[^](#cite_ref-5)** Altman, Lawrence K. (23 November 2004). ["Treating Troubling Fibroids Without Surgery"](https://www.nytimes.com/2004/11/23/health/treating-troubling-fibroids-without-surgery.html). *The New York Times*.

1. **[^](#cite_ref-6)** ["PMA P040003 Supplement 15 (ExAblate) index page"](https://web.archive.org/web/20161230045957/http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P040003S015). FDA. August 31, 2015. Archived from [the original](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040003S015) on December 30, 2016.

1. **[^](#cite_ref-7)** ["PMA P110039 (ExAblate) index page"](https://web.archive.org/web/20161230045849/http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P110039). FDA. October 18, 2012. Archived from [the original](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110039) on December 30, 2016.

1. **[^](#cite_ref-8)** [Yoav Medan](https://www.ted.com/speakers/yoav_medan), *ted.com*

1. **[^](#cite_ref-9)** ["InSightec's ExAblate Neuro System Awarded European CE Mark for Non-invasive Treatment of Neurological Disorders in the Brain"](https://www.prnewswire.com/news-releases/insightecs-exablate-neuro-system-awarded-european-ce-mark-for-non-invasive-treatment-of-neurological-disorders-in-the-brain-181981381.html) (Press release). InSightec. 4 December 2012. Retrieved 2018-08-09 – via PR Newswire.

1. **[^](#cite_ref-10)** Garde, Damian (July 29, 2013). ["InSightec takes to China with uterine fibroid device"](http://www.fiercebiotech.com/medical-devices/insightec-takes-to-china-uterine-fibroid-device). *FierceBiotech*.

1. **[^](#cite_ref-11)** ["PMA P150038 (ExAblate Neuro) index page"](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150038). FDA. July 11, 2016.

1. **[^](#cite_ref-12)** Al Idrus, Amirah (August 24, 2016). ["Pivotal data for Insightec's noninvasive essential tremor device published in NEJM"](http://www.fiercebiotech.com/medical-devices/pivotal-data-for-insightec-s-noninvasive-essential-tremor-device-published-nejm). *FierceBiotech*.

1. **[^](#cite_ref-FerreHire_13-0)** Lawrence, Stacy (January 8, 2016). ["Insightec raises $22M, brings on Mako Surgical co-founder as CEO"](http://www.fiercebiotech.com/medical-devices/insightec-raises-22m-brings-mako-surgical-co-founder-as-ceo). *FierceBiotech*.

1. **[^](#cite_ref-14)** Al Idrus, Amirah (August 15, 2016). ["Siemens, Insightec partner on novel essential tremor treatment"](http://www.fiercebiotech.com/medical-devices/siemens-healthineers-insightec-to-expand-access-to-novel-essential-tremor-treatment). *FierceBiotech*.

## External links

- [Official website](http://www.insightec.com)

---
Adapted from the Wikipedia article [Insightec](https://en.wikipedia.org/wiki/Insightec) by Wikipedia contributors ([contributor history](https://en.wikipedia.org/wiki/Insightec?action=history)). Available under [Creative Commons Attribution-ShareAlike 4.0 International](https://creativecommons.org/licenses/by-sa/4.0/). Changes may have been made.