AUS
NZ
UK
CA
USA
FRA
GER
ESP
ITA
NLD
PRT
SWE
GRC
IND
POL
BRA
ZAF
RUS
CHN
UAE
.jpg)
Summary
- Israel-headquartered INSIGHTEC has obtained market approval from China’s National Medical Products Administration for its Exablate® 4000 platform.
- The platform enables INSIGHTEC’s unilateral focused ultrasound treatment for patients suffering from debilitating tremor.
- Exablate Neuro has obtained marketing authorisation for Essential Tremor from the FDA, TGA and other regulatory bodies.
A global medical technology innovator INSIGHTEC Inc updated the market that the Company has obtained market approval from the National Medical Products Administration (NMPA) for its Exablate Neuro platform. NMPA is a Chinese agency which focuses on the regulation of medicines and medical devices.
Let us delve deep and discuss in detail-
MR-guided Focused Ultrasound to be available in China
According to PR Newswire, China’s NMPA has given the green light to INSIGHTEC for its Exablate® 4000 (Exablate Neuro) platform. This platform will enable INSIGHTEC’s unilateral focused ultrasound treatment for patients suffering from debilitating tremor.
The tremor could be from Essential Tremor as well as Tremor-dominant Parkinson's Disease (PD) that has not responded to other treatments.
MR-guided Focused Ultrasound (Image Source: INSIGHTEC Website)
INSIGHTEC’s proprietary MR-guided Focused Ultrasound technology is based on over 20 years of scientific knowledge and clinical investigation.
The Company’s award-winning Exablate® Neuro platform offers sound waves targeted to treat deep in the brain without any incisions.
Maurice R. Ferré MD, CEO and Chair of INSIGHTEC, commented:
Exablate Neuro has obtained marketing authorisation for Essential Tremor from the Food and Drug Administration (FDA) and Therapeutic Goods Administration (TGA). Furthermore, it is also approved by regulatory agencies in Argentina, Canada, Chile, Europe, Israel, Japan, Kazakhstan, Korea, Russia, Taiwan, and Turkey.
(Image Source: INSIGHTEC Website)
MRgFUS or MR-guided Focused Ultrasound is also referred to as the high-intensity Focused Ultrasound. MRgFUS provides acoustic energy specifically to the Vim of the thalamus to heat and ablate the tissue. Notably, this procedure does not need any anesthesia, implants, or surgical incisions.
Almost 60 leading neurosurgeons worldwide are treating patients suffering from tremor due to Essential Tremor or Tremor-dominant PD on a regular basis by using the Exablate Neuro platform.
INSIGHTEC in a nutshell
A global fast-growing medical technology player INSIGHTEC is engaged in the development of the next generation of patient care by realising the therapeutic power of acoustic energy. Exablate® Neuro platform of the Company focuses on sound waves, which are guided by MRI.
INSIGHTEC is the first Company that developed an innovative neurosurgery platform. The Exablate Neuro platform can provide ultrasound energy deep in the brain to generate a lesion without incisions.
Benefits of MR-guided Focused Ultrasound Treatment
(Image Source: INSIGHTEC Website)
