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 intact skull.
“This important milestone is directly attributed to the commitment and collaboration of the teams at Insightec and Siemens Healthineers, who met the challenge head-on," Insightec CEO & board chair Dr. Maurice Ferré said in a press release.
"Expansion of MRI compatibility for Exablate Neuro substantially increases the potential reach of incisionless brain surgery for essential tremor patients,” Ferré said,
Insightec said that with the clearance, its Exablate Neuro is now indicated for use with Siemens Healthineer’s Magnetom Skyra, Prisma and Prima[fit] MRI machines for treating patients with essential tremor.
“With the compatibility of Insightec’s innovative technology with our MRI scanners, Siemens Healthineers is staying true to its mission of delivering best-in-class diagnostic imaging with advanced therapy solutions in the neurological space,” Siemens Healthineers magnetic resonance GM Dr. Christoph Zindel said in a prepared statement.
"This joint development underlines our commitment to expanding precision medicine, and paving the way for offering a focused ultrasound to more hospitals and patients in our worldwide network," said Zindel.
In July, Insightec said 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.
“With Medicare coverage now available in 16 states, with that number poised to more than double, more patients than ever will now have access to Insightec’s innovative ET solution,” Ferré said in prepared remarks.
“We are confident that additional hospitals will be encouraged to offer our technology to improve patient lives, which is our ultimate goal,” Ferré said.
“Coverage in these six additional states will help treatment centers offer more patients access to the incisionless focused ultrasound treatment for ET,” Dee Kolanek, VP of reimbursement, added.
“Millions of Americans suffer from essential tremor, which can impact a person’s ability to function in the workplace and live an independent and active lifestyle.”