Insightec announced today that it received FDA 510(k) clearance for its Exablate Prostate system for treating prostate tissue. Haifa, Israel-based Insightec designed its Exablate Prostate system to use high-intensity focused ultrasound to ablate targeted tissue in the prostate. Health providers perform the procedure under magnetic resonance imaging (MRI) guidance for high-resolution visualization of the patient’s […]
INSIGHTEC
MedTech 100 roundup: Industry roars back
In the blink of an eye, the medtech industry exited its spring slump and neared its all-time best performance levels. MassDevice‘s MedTech 100 Index offered signs of a rebound last week and has built on that momentum, registering a final tally of 109.39 points on April 9. That represents a 2.9% increase from the 106.26-point mark […]
Insightec raises $136M for incisionless surgery tech
Insightec raised more than $136 million in a recent funding round, according to a Form D that the incisionless surgery tech company filed today with the SEC. The Tirat Carmel, Israel–based company — whose technology uses MR-guided focused ultrasound to perform surgeries — had sought a total of $150 million in the money-raise. The company […]
Philips, InSightec team up on ultrasound for neurosurgery
Royal Philips (NYSE:PHG) announced that it is collaborating with InSightec to expand access to MR-guided focused ultrasound. Amsterdam-based Philips plans to develop compatibility between its advanced MR system and InSightec’s Exablate Neuro platform to expand access to MR-guided focused ultrasound for incision-less neurosurgery in treating essential tremor and other neurological disorders, according to a news release. […]
Insightec wins Medicare coverage for incisionless neurosurgery platform
Insightec announced today that it has secured complete Medicare coverage across the U.S. for its MR-guided focused ultrasound treatment of medication-refractory essential tremor. The coverage comes roughly four years since the Tirat Carmel, Israel–based company won FDA approval for the technology. Insightec officials said compelling clinical evidence and support from physicians, specialty societies and patients […]
Insightec raises another $150m for incisionless neurosurgery platform
Insightec announced that it signed definitive agreements for a $150 million Series F financing round with a post-money valuation of $1.3 billion. The Haifa, Israel–based company is the developer of the Exablate Neuro incisionless neurosurgery platform. Insightec touts the Exablate Neuro as the first MR-guided focused ultrasound device to win FDA approval for treating certain […]
Insightec wins expanded Medicare coverage for essential tremor treatment
Incisionless neurosurgery company Insightec said it has won Medicare coverage for its Neuravive MR-guided focused ultrasound device in 13 more states, effective April 1, 2019. Health insurance administrator Noridian extended coverage to Medicare recipients in Alaska, Arizona, California, Hawaii, Idaho, Montana, Nevada, North Dakota, Oregon, South Dakota, Utah, Washington, and Wyoming. Insightec’s Neuravive technology is designed to treat essential tremor […]
FDA expands indication for Insightec’s Exablate Neuro in Parkinson’s
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 […]
