 | |
| Type | Private |
|---|---|
| Industry | Medical devices |
| Founded | 1999 |
| Headquarters | , Israel |
Area served | Worldwide |
| Products | Exablate, Exablate Neuro |
| Website | Insightec.com |
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. [1]
The company was founded by Kobi Vortman and Oded Tamir, with seed investment from Elbit Medical Imaging and GE Healthcare.[ citation needed ]
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; [2] [3] and in 2015 it obtained a PMA to expand the marketing of the system to treat uterine fibroids in any woman. [4] 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. [5]
In 2011, the company's work was featured in TEDMED by Yoav Medan, chief systems architect. [6]
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. [7] It won approval to market the system for uterine fibroids in China in 2013. [8]
In 2016, Insightec obtained a PMA from the FDA to market its Exablate Neuro system to treat essential tremor, [9] and the next month published data from the pivotal trial in the New England Journal of Medicine. [10]
In 2016, the company hired Maurice R. Ferré, the founder and former CEO of Mako Surgical, as its CEO. [11] Later that year, the company signed an agreement with Siemens to integrate the device with Siemens' MRI systems. [12]
Essential tremor (ET), also called benign tremor, familial tremor, and idiopathic tremor, is a medical condition characterized by involuntary rhythmic contractions and relaxations of certain muscle groups in one or more body parts of unknown cause. It is typically symmetrical, and affects the arms, hands, or fingers; but sometimes involves the head, vocal cords, or other body parts. Essential tremor is either an action (intention) tremor—it intensifies when one tries to use the affected muscles during voluntary movements such as eating and writing—or it is a postural tremor, present with sustained muscle tone. This means that it is distinct from a resting tremor, such as that caused by Parkinson's disease, which is not correlated with movement.
Heavy menstrual bleeding (HMB), previously known as menorrhagia or hematomunia, is a menstrual period with excessively heavy flow. It is a type of abnormal uterine bleeding (AUB).
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Adenomyosis is a medical condition characterized by the growth of cells that proliferate on the inside of the uterus (endometrium) atypically located among the cells of the uterine wall (myometrium), as a result, thickening of the uterus occurs. As well as being misplaced in patients with this condition, endometrial tissue is completely functional. The tissue thickens, sheds and bleeds during every menstrual cycle.
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 bladder, causing a frequent need to urinate. They may also cause pain during penetrative sex or lower back pain. A woman can have one uterine fibroid or many. Occasionally, fibroids may make it difficult to become pregnant, although this is uncommon.
Radiofrequency ablation (RFA), also called fulguration, is a medical procedure in which part of the electrical conduction system of the heart, tumor or other dysfunctional tissue is ablated using the heat generated from medium frequency alternating current. RFA is generally conducted in the outpatient setting, using either local anesthetics or twilight anesthesia. When it is delivered via catheter, it is called radiofrequency catheter ablation.
High-intensity focused ultrasound (HIFU) is a non-invasive therapeutic technique that uses non-ionizing ultrasonic waves to heat or ablate tissue. HIFU can be used to increase the flow of blood or lymph or to destroy tissue, such as tumors, via thermal and mechanical mechanisms. Given the prevalence and relatively low cost of ultrasound generation mechanisms, The premise of HIFU is that it is expect a non-invasive and low-cost therapy that can at minimum outperform operating room care.
Endometrial ablation is a surgical procedure that is used to remove (ablate) or destroy the endometrial lining of the uterus. The goal of the procedure is to decrease the amount of blood loss during menstrual periods. Endometrial ablation is most often employed in people with excessive menstrual bleeding, who do not wish to undergo a hysterectomy, following unsuccessful medical therapy.
A menstrual disorder is characterized as any abnormal condition with regards to a woman's menstrual cycle. There are many different types of menstrual disorders that vary with signs and symptoms, including pain during menstruation, heavy bleeding, or absence of menstruation. Normal variations can occur in menstrual patterns but generally menstrual disorders can also include periods that come sooner than 21 days apart, more than 3 months apart, or last more than 10 days in duration. Variations of the menstrual cycle are mainly caused by the immaturity of the hypothalamic-pituitary-ovarian (HPO) axis, and early detection and management is required in order to minimize the possibility of complications regarding future reproductive ability.
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Neurocrine Biosciences, Inc. is an American biopharmaceutical company founded in 1992. The company is headquartered in San Diego, California, and led by CEO Kevin Gorman. Neurocrine develops treatments for neurological and endocrine-related diseases and disorders. In 2017, the company's drug valbenazine (Ingrezza) was approved in the US to treat adults with tardive dyskinesia (TD).
Samsung Medison Co., Ltd. (Korean: 삼성메디슨) is a manufacturer of diagnostic ultrasound systems. The company was founded in 1985 and acquired by Samsung in 2010 with the purchase reported to be at more than $262 million US dollars. In 2020, Samsung Medison was selling its medical devices in 110 countries, which accruals up to 85 percent of its total sales.
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Ulipristal acetate, sold under the brand name Ella among others, is a medication used for emergency contraception and uterine fibroids. As emergency contraception it should be used within 120 hours of vaginally penetrating intercourse. For fibroids it may be taken for up to six months. It is taken by mouth.
Sonalleve MR-HIFU is a medical system developed by Philips Healthcare for the treatment of uterine fibroids without surgery. The system uses non-invasive high-intensity focused ultrasound (HIFU) guided by magnetic resonance (MR), whence the acronym MR-HIFU. The procedure involves volumetric heating of fibroids with real-time feedback. In June 2017, Philips and Profound Medical announced an agreement to transfer Philips' MR-HIFU business, which includes the Sonalleve system, to Profound Medical.
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