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Insightec

Medical device company

Summary

Medical device company

Field	Value
name	INSIGHTEC Ltd.
logo	INSIGHTEC LOGO FINAL RGB.jpg
type	Private
foundation
hq_location_city	Tirat Carmel
hq_location_country	Israel
area_served	Worldwide
industry	Medical devices
products	Exablate, Exablate Neuro
services
homepage	Insightec.com

INSIGHTEC Ltd., is an Israeli privately held medical device company that sells MR guided Focused Ultrasound equipment. The technology can destroy deep tissue in the body without the need for incisions.

History

The company was founded by Kobi Vortman and Oded Tamir, with seed investment from Elbit Medical Imaging and GE Healthcare.

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 2011, the company's work was featured in TEDMED by Yoav Medan, chief systems architect.

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.

References

(April 2011). "Focused Ultrasound Surgery in Oncology: Overview and Principles". Radiology.
(October 22, 2004}}{{dead link). "PMA P040003 (ExAblate) index page". FDA.
(23 November 2004). "Treating Troubling Fibroids Without Surgery". The New York Times.
(August 31, 2015). "PMA P040003 Supplement 15 (ExAblate) index page". FDA.
(October 18, 2012). "PMA P110039 (ExAblate) index page". FDA.
[https://www.ted.com/speakers/yoav_medan Yoav Medan], ''ted.com''
(4 December 2012). "InSightec's ExAblate Neuro System Awarded European CE Mark for Non-invasive Treatment of Neurological Disorders in the Brain". InSightec.
(July 29, 2013). "InSightec takes to China with uterine fibroid device". FierceBiotech.
(July 11, 2016). "PMA P150038 (ExAblate Neuro) index page". FDA.
(August 24, 2016). "Pivotal data for Insightec's noninvasive essential tremor device published in NEJM". FierceBiotech.
(January 8, 2016). "Insightec raises $22M, brings on Mako Surgical co-founder as CEO". FierceBiotech.
(August 15, 2016). "Siemens, Insightec partner on novel essential tremor treatment". FierceBiotech.

Wikipedia Source

This article was imported from Wikipedia and is available under the Creative Commons Attribution-ShareAlike 4.0 License. Content has been adapted to SurfDoc format. Original contributors can be found on the article history page.

medical-imaging-equipment-manufacturers medical-technology-companies-of-israel medical-device-manufacturers israeli-companies-established-in-1999

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