imported>GreenC bot: Rescued 3 archive links. Wayback Medic 2.5 per WP:URLREQ#fda.gov

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Rescued 3 archive links. Wayback Medic 2.5 per WP:URLREQ#fda.gov

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{{Short description|Medical device company}}
{{Infobox company
| name = INSIGHTEC Ltd.
| logo = INSIGHTEC LOGO FINAL RGB.jpg
| type = [[Privately held company|Private]]
| foundation = {{start date and age|1999}}
| hq_location_city = [[Tirat Carmel]]
| hq_location_country = Israel
| key_people =
| area_served = Worldwide
| industry = [[Medical devices]]
| products = Exablate, Exablate Neuro
| services = |
| homepage = [http://www.Insightec.com/ Insightec.com]
| logo_size =
}}
'''INSIGHTEC Ltd.''', is an [[Israel]]i privately held medical device company that sells [[High-intensity focused ultrasound|MR guided Focused Ultrasound]] equipment. The technology can destroy deep tissue in the body without the need for incisions.<ref>{{Cite journal|last1=Tempany|first1=Clare M. C.|last2=McDannold|first2=Nathan J.|last3=Hynynen|first3=Kullervo|last4=Jolesz|first4=Ferenc A.|date=April 2011|title=Focused Ultrasound Surgery in Oncology: Overview and Principles|journal=Radiology|volume=259|issue=1|pages=39–56|doi=10.1148/radiol.11100155|pmc=3064817|issn=0033-8419|pmid=21436096}}</ref>

==History==
The company was founded by Kobi Vortman and Oded Tamir, with seed investment from [[Elbit Medical Imaging]] and [[GE Healthcare]].{{Citation needed|date=June 2020}}

The company obtained [[Federal Food, Drug, and Cosmetic Act#Premarket approval .28PMA.29|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;<ref>{{cite web|title=PMA P040003 (ExAblate) index page|url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040003|publisher=FDA|date=October 22, 2004}}{{dead link|date=May 2025|bot=medic}}{{cbignore|bot=medic}}</ref><ref>{{cite news|last1=Altman|first1=Lawrence K.|title=Treating Troubling Fibroids Without Surgery|url=https://www.nytimes.com/2004/11/23/health/treating-troubling-fibroids-without-surgery.html|work=The New York Times|date=23 November 2004}}</ref> and in 2015 it obtained a PMA to expand the marketing of the system to treat uterine fibroids in any woman.<ref>{{cite web|title=PMA P040003 Supplement 15 (ExAblate) index page|url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040003S015|archive-url=https://web.archive.org/web/20161230045957/http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P040003S015|url-status=dead|archive-date=December 30, 2016|publisher=FDA|date=August 31, 2015}}</ref> 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.<ref>{{cite web|title=PMA P110039 (ExAblate) index page|url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110039|archive-url=https://web.archive.org/web/20161230045849/http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P110039|url-status=dead|archive-date=December 30, 2016|publisher=FDA|date=October 18, 2012}}</ref>

In 2011, the company's work was featured in [[TEDMED]] by Yoav Medan, chief systems architect.<ref>[https://www.ted.com/speakers/yoav_medan Yoav Medan], ''ted.com''</ref>

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.<ref>{{Cite press release|url=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|title=InSightec's ExAblate Neuro System Awarded European CE Mark for Non-invasive Treatment of Neurological Disorders in the Brain|website=www.prnewswire.com|language=en|access-date=2018-08-09}}</ref> It won approval to market the system for uterine [[Fibroin|fibroids]] in China in 2013.<ref>{{cite news|last1=Garde|first1=Damian|title=InSightec takes to China with uterine fibroid device|url=http://www.fiercebiotech.com/medical-devices/insightec-takes-to-china-uterine-fibroid-device|work=FierceBiotech|date=July 29, 2013|language=en}}</ref>

In 2016, Insightec obtained a PMA from the FDA to market its Exablate Neuro system to treat [[essential tremor]],<ref>{{cite web|title=PMA P150038 (ExAblate Neuro) index page|url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150038|publisher=FDA|date=July 11, 2016}}</ref> and the next month published data from the pivotal trial in the ''New England Journal of Medicine''.<ref>{{cite news|last1=Al Idrus|first1=Amirah|title=Pivotal data for Insightec's noninvasive essential tremor device published in NEJM|url=http://www.fiercebiotech.com/medical-devices/pivotal-data-for-insightec-s-noninvasive-essential-tremor-device-published-nejm|work=FierceBiotech|date=August 24, 2016|language=en}}</ref>

In 2016, the company hired [[Maurice R. Ferré]], the founder and former CEO of [[MAKO Surgical Corp.|Mako Surgical]], as its CEO.<ref name="FerreHire">{{cite news|url=http://www.fiercebiotech.com/medical-devices/insightec-raises-22m-brings-mako-surgical-co-founder-as-ceo|title=Insightec raises $22M, brings on Mako Surgical co-founder as CEO|last1=Lawrence|first1=Stacy|date=January 8, 2016|work=FierceBiotech|language=en}}</ref> Later that year, the company signed an agreement with [[Siemens]] to integrate the device with Siemens' MRI systems.<ref>{{cite news|last1=Al Idrus|first1=Amirah|title=Siemens, Insightec partner on novel essential tremor treatment|url=http://www.fiercebiotech.com/medical-devices/siemens-healthineers-insightec-to-expand-access-to-novel-essential-tremor-treatment|work=FierceBiotech|date=August 15, 2016|language=en}}</ref>

==References==
{{reflist}}

==External links==
*{{Official website|http://www.insightec.com}}

[[Category:Medical imaging equipment manufacturers]]
[[Category:Medical technology companies of Israel]]
[[Category:Medical device manufacturers]]
[[Category:Israeli companies established in 1999]]

Insightec - Revision history

imported>GreenC bot: Rescued 3 archive links. Wayback Medic 2.5 per WP:URLREQ#fda.gov