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Article source: MEDI:GATE NEWS
Article Link: https://m.medigatenews.com/news/1867873748
iMediSync announced that the company’s medical device EEG scanner, iSyncWave, had been granted 510k clearance from the US Food and Drug Administration (FDA) on August 10th.
According to the company, iSyncWave is a dry EEG scanner that does not require electrode gel for use and it is easy to wear and measure EEG as the size of the device can be adjusted in accordance with various types of heads, keeping the internationally standardized 10/20 system.
It is an EEG scanner analyzing the QEEG (Quantitative Electroencephalogram) in a short amount of time associated with the Big Data-based automatic cloud analysis system.
This product was recently registered as an innovative prototype product by Public Procurement Service in Korea and was introduced into the mobile medical checkup service at Pusan National University Hospital.
Various data are being collected while measuring EEG with iSyncWave for various patients such as Stroke, and Parkinson’s disease at leading university hospitals in Korea, such as Seoul National University Hospital and Asan Medical Center.
It will also be introduced at the EEG seminar for children with developmental disabilities to be held at the University of Oxford in September.
After this FDA 510k clearance, iMediSync plans to increase overseas sales.
An official from iMediSync said, “After CES 2022, we have been receiving many inquiries from the US, Europe, Australia, and other countries and particularly inquiries on research and clinical introduction from leading universities and institutions around the world, after participating in AAIC (Alzheimer’s Association International Conference) held during July 31 – August 4.” “With FDA 510k clearance, we can not only provide the product information but can also conduct collaborative research and sell the products. To respond to countries that require registration other than from the FDA for import, we are also preparing for the registration for CE (EU) and TGA (Australia).” he said.
