Insightec said today it won FDA approval for its Exablate Neuro model 4000 system, now cleared for use with 1.5 Tesla magnetic resonance imaging for treating essential tumor in patients non-responsive to medication. The Exablate Neuro device uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed […]
InSightec Ltd
Insightec touts 1st patient treated in Exablate Neuro FDA feasibility trial
Insightec today announced that the 1st patient has been treated in a feasibility trial exploring the use of its Exablate Neuro system for treating benign centrally-located intracranial tumors in pediatric and young adults. The Exablate Neuro device uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed […]
Insightec’s Exablate wins CE Mark approval for prostate treatment, Japanese approval for essential tremor
Insightec this week announced 2 regulatory wins, receiving CE Mark approval in the European Union for its Exablate Prostate for treating locally-confined prostate cancer and Japanese approval for its Exablate Neuro for treating essential tremor. The Exablate Prostate system uses focused ultrasound to target and ablate tissue in the prostate while minimizing damage to adjacent structures, […]
Insightec touts near 50% tremor score improvement in pivotal Exablate Neuro study
Insightec today touted results from a pivotal study of its Exablate Neuro system, which met its primary endpoint with patients treated with the system reporting a 47% improvement in a composite tremor score at 3 months. Data from the study were published today in the New England Journal of Medicine. “MRI imaging and thermometry provide a high level […]
Insightec inks ExAblate co-development deal with Siemens
Insightec said today it inked a collaborative strategic deal with Siemens Healthineers (NYSE:SI) to develop compatibility between Insightec’s Exablate Neuro system and Siemens Magnetom Aera and Skyra 1.5 Tesla and 3T clinical MRI systems. The companies said the agreement will expand Siemens diagnostic imaging portfolio and will allow existing and future Siemens MRI customers access to the […]
FDA approves Insightec’s Exablate Neuro focused ultrasound device
UPDATED July 12, 2016, with comment from study investigators, Insightec CEO. The FDA said today that it approved the Exablate Neuro device made by Insightec for treating essential tremor in patients who don’t respond to drug therapy. The Exablate Neuro device uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance […]
Insightec pulls in $22m, taps board chair Ferré as CEO
Insightec said today it secured a $22 million investment and tapped Dr. Maurice Ferré as its new CEO, with former CEO Kobi Vortman stepping down and taking a seat on the board. The $22 million comes from a current stakeholder as part of a Series D round of financing, the Israeli company said. Newly assigned […]
Insightec touts reimbursement win for Exablate
Insightec said today it received positive coverage policies from Blue Cross Blue Shield licensees for its Exablate magnetic resonance imaging-guided focused ultrasound device for pain palliation treatments for bone metastases The recent round of favorable coverage policies for the Exablate came from BCBS Louisiana, Florida Blue, Independence BCBS, Highmark BCBS and Blue Shield of California, the […]
Insightec files PMA for Exablate Neuro
Insightec said today it submitted a premarket approval application to the FDA for its Exablate Neuro device seeking an indication to treat essential tremors. The Exablate Neuro uses high intensity focused ultrasound to thermally ablate targeted tissue and uses continuous magnetic resonance imaging to visualize anatomy to plan and monitor treatments and outcomes. The MR-guided focused […]
Insightec wins expanded FDA nod for Exablate device
Insightec said today it won expanded FDA premarket approval for its next generation Exablate system used to treat symptomatic uterine fibroids for patients who wish to retain their uterus and fertility. The Exablate system uses both focused ultrasound to ablate fibroid tissue and magnetic resonance imaging to guide the ultrasound ablation to specific tissue targets, the […]
