Insightec said this week that the FDA approved an expansion for the Exablate Neuro device to include the treatment of patients with tremor-dominant Parkinson’s disease. The company’s device uses focused ultrasound to perform an incision-less thalamotomy, guided by MR imaging. The Exablate Neuro was previously only approved for medication-refractory essential tremor. “This is another validation […]
Sanuwave confirms acting CEO Richardson as company head | Personnel Moves – December 12, 2018
Sanuwave said late last month that it lifted acting CEO and board chair Kevin Richardson to a permanent position in the corner office. Richardson joined the Suwanee, Ga.-based company in 2009 as board chair, and has served as acting CEO since 2014. He also served as managing partner of investment management firm Prides Capital from […]
Insightec touts another CMS win for MR-guided focused ultrasound
Insightec said today it won Medicare benefit coverage from CGS Medicare and Palmetto GBA for procedures using its Neuravive MR-guided focused ultrasound system to treat essential tremor. The Israel-based company said that with the addition, 25 states now cover its Neuravive treatment for medication-refractory essential tremor. “2018 marks the year of Medicare reimbursement for incisionless focused […]
FDA green-lights Insightec’s Exablate for use with select Seimens MRI scanners
Insightec said today that it won expanded FDA approval for its Exablate Neuro, which is now cleared as compatible with a number of Siemens (NYSE:SI) Healthineer’s magnetic resonance imaging scanners. The Israel-based company’s Exablate Neuro device uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed non-invasively through an […]
Insightec logs Medicare win for MR-guided focused ultrasound in treating essential tremor
Insightec said today that it won Medicare benefit coverage for its MR-guided focused ultrasound system for the treatment of essential tremor in six new states, bringing the total number of states with Medicare coverage for its tech to 16. The company’s system will now be covered under Medicare in Indiana, Iowa, Kansas, Nebraska, Michigan and […]
Insightec wins Medicare coverage in 10 states
Insightec has won Medicare coverage for its magnetic technology that treats essential tremor via ultrasound. The Centers for Medicare and Medicaid Services have approved the company’s Exablate Neuro device for patients in 10 U.S. states and will add coverage for six more states July 1, according to a company statement. Additional Medicare administrative contractors have issued […]
Insightec seeks Parkinson’s indication in Japan for Exablate Neuro
Insightec said this week it submitted an application for pre-market approval to the Japanese Pharmaceuticals and Medical Devices Agency seeking an indication for its Exablate Neuro to treat advanced Parkinson’s Disease in patients suffering from mobility, rigidity or dyskinesia. The Israel-based company’s Exablate Neuro device uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous […]
Insightec closes $150m Series E
Insightec said today it closed a $150 million Series E private equity round of financing with plans to use funds to support marketing, commercialization and further development of its Exablate Neuro platform. The round was led by Koch Disruptive Technologies subsidiary Koch Industries, who invested a total of $100 million during the round, the Israel-based company […]
Insightec, Virginia Tech collab on focused ultrasound brain disorder R&D
Insightec said today it is partnering with the Virginia Tech Carilion Research Institute looking to develop treatments for brain disorders utilizing the company’s Exablate Neuro focused ultrasound device. The treatments will also utilize Siemens (NYSE:SI) magnetic resonance imaging devices, with potential applications in treating cancer, brain tumors, targeted disruptions of the blood-brain barrier for therapeutic delivery and neuromodulation […]
Insightec raises $150m in Series E
Insightec said yesterday it raised $150 million in a Series E round of financing led by Koch Industries’ Koch Disruptive Technologies to support its MRI-guided focused ultrasound technologies. The round was led by Koch Disruptive Technologies and joined by existing investors Elbit Imaging, York Capital, Focus Holdings, GE Healthcare (NYSE:GE), GEOC and Meditech Advisors, the Israel-based company […]
Insightec wins FDA nod for Exablate Neuro glioblastoma trial
Insightec said today it won FDA approval to launch a safety and feasibility trial of its Exablate Neuro, testing its ability to disrupt the blood brain barrier in patients with glioblastoma. The Exablate Neuro device, which won FDA approval last July for treating essential tremor, uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by […]
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