INSIGHTEC Ltd., is a 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. The company's proprietary devices are called Exablate and Exablate Neuro, to treat indications in the body and the brain, respectively. The company was founded by Kobi Vortman and Oded Tamir, with seed investment from

Elbit Medical Imaging Elbit Imaging Ltd., formerly Elbit Medical Imaging Ltd., is an Israeli holding company with activities in real estate, medical imaging, hotels, shopping malls, and retail. The company was founded as a spin-off from Elron Electronic Industries an ...

and

GE Healthcare GE HealthCare is a subsidiary of American multinational conglomerate General Electric incorporated in New York and headquartered in Chicago, Illinois. As of 2017, it is a manufacturer and distributor of diagnostic imaging agents and radiopharma ...

. The company obtained

premarket approval The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of f ...

(PMA) from the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA) in 2004 to market its Exablate system to treat

uterine fibroids Uterine fibroids, also known as uterine leiomyomas or fibroids, are benign smooth muscle tumors of the uterus. Most women with fibroids have no symptoms while others may have painful or heavy periods. If large enough, they may push on the bl ...

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 TEDMED is an annual conference focusing on health and medicine, with a year-round web-based community. TEDMED is an independent event operating under license from the nonprofit TED conference. Background , TEDMED staff operates from Stamfor ...

by Yoav Medan, chief systems architect. In 2012, the company received European

CE mark On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certification ...

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 Essential tremor (ET), also called benign tremor, familial tremor, and idiopathic tremor, is a medical condition characterized by involuntary rhythmic contractions and relaxations ( oscillations or twitching movements) of certain muscle groups in ...

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 , better known by the mononym name Mako (sometimes stylised MAKO), is a Japanese voice actress, singer and a member of the band Bon-Bon Blanco, in which her prominent role is as the maraca player. She has also performed in a Japanese television d ...

, as its CEO. Later that year the company signed an agreement with

Siemens Siemens AG ( ) is a German multinational conglomerate corporation and the largest industrial manufacturing company in Europe headquartered in Munich with branch offices abroad. The principal divisions of the corporation are ''Industry'', '' ...

to integrate the device with Siemens' MRI systems.

References

External links

*{{Official website, http://www.insightec.com Medical technology companies of Israel Medical imaging Medical device manufacturers Israeli companies established in 1999