Category: InSightec Ltd
Canadian regulators give InSightec a nod of approval for the ExAblate system to treat benign uterine tumors and painful metastatic bone tumors.
Canadian healthcare regulators approved InSightec's ExAblate ultrasound system, clearing the device for use against 2 different diseases. Health Canada granted ExAblate indication to break up benign uterine tumors and to alleviate painful symptoms of metastatic bone tumors.
Chinese regulators hand InSightec regulatory approval for the ExAblate ultrasound-based therapy to treat non-cancerous uterine tumors.
Israeli device maker InSightec landed a green light from the Chinese Food & Drug Administration for its ExAblate MRI-guided focused ultrasound therapy, with an indication to treat non-cancer-causing tumors in the uterus.
These tumors, called uterine fibroids, occur in more than 20% of women of childbearing age, according to the company. ExAblate is an incision-free treatment that uses ultrasound frequencies to ablate tumors.
InSightec completes $30.9 million Series C financing round, led by GE Healthcare and other investors. Lands CE Marked approval for its ExAblate Neuro in the treatment of Parkinson's disease.
InSightec picked off $30.9 million in a Series C financing round, led by a $27.6 million investment from GE Healthcare and $3.3 million by other investors, the company said.
In addition, the Israeli-based ultrasound maker also named VP & general manager of the MRI business James Davis as new CEO and Tom Gentile as chairman of board. Gentile most recently was
president & CEO of GE Healthcare.
Israeli device maker InSightec lands FDA approval to treat painful bone metastases with its ExAblate ultrasound-based therapy.
Israeli device maker InSightec won FDA approval for its ExAblate MRI-guided focused ultrasound therapy with indication to treat pain resulting from bone metastases in patients who failed or aren't good candidates for radiation therapy.
Bone metastases occur when cancer cells break off from the primary tumor site and spread to other parts of the body, commonly leaving patients with significant physical and emotional pain, according to a press release.
The FDA approves clinical trials of InSightec's ExAblate Neuro in treatment of medication-resistant Parkinson's disease.
The FDA approved U.S. studies of Israel-based InSightec's ExAblate Neuro in treatment of medication resistant Parkinson's disease.
InSightec will enroll 30 patients who suffer from tremors associated with the disease, randomizing them for treatment with ultrasound-based deep-lesioning of the brain.