Medical technology firm Insightec has secured approval from the US Food and Drug Administration (FDA) for Exablate Neuro compatibility with Siemens Healthineers’ MRI scanners.
Image: Insightec has received FDA approval for Exablate Neuro compatibility with Siemens’ MRI scanners. Photo: courtesy of INSIGHTEC.
The FDA has approved Exablate Neuro compatibility for Siemens’ MRI scanners such as Magnetom Skyra, Prisma and Prisma to treat patients with essential tremor (ET).
Exablate Neuro is an advanced medical technology, which uses focused ultrasound along with MR imaging to accurately target and treat areas deep within the brain through an intact skull.
Insightec CEO and board chairman Dr Maurice Ferré said: “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.
“Expansion of MRI compatibility for Exablate Neuro substantially increases the potential reach of incisionless brain surgery for essential tremor patients.”
Exablate Neuro deploys focused ultrasound to accurately target and ablate tissue deep within the brain with no incisions.
According to Insightec, more than 1,500 medication-refractory essential tremor patients were treated across the globe.
Insightec secured FDA approval for the treatment of medication-refractory essential tremor, and clinical trials are also underway to assess potential applications in the treatment of various neurological diseases.
The neurosurgeons will use Exablate Neuro to perform the Neuravive treatment for delivering immediate and durable tremor relief for essential tremor patients.
Insightec also collaborated with major academic and medical institutions to conduct research for future applications in the neuroscience space.
Siemens Healthineers magnetic resonance general manager and senior vice president Dr Christoph Zindel said: “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.”
In February this year, Insightec secured funding to commercialise Exablate Neuro medical technology to treat essential tremors, as well as to support research and development on ther brain indications such as Parkinson’s disease, Alzheimer’s disease, and cancer.
With headquarters in Haifa of Israel and Miami of Florida, Insightec has offices Dallas, Tokyo and Shanghai.