www.fdanews.com/articles/209571-imedisyncs-brain-scanner-gains-510k-clearance
iMediSync’s Brain Scanner Gains 510(k) Clearance
September 28, 2022
South Korea-based iMediSync has received 510(k) clearance from the FDA for its iSyncWave brain scanner.
The wearable, “dry” electroencephalogram (EEG) scanner does not require the use of electrode gel and can be adjusted to accommodate various head shapes.
The iSyncWave is an integrated EEG and neurotherapeutics device that can provide care through an artificial intelligence-based software platform that uses automated cloud analysis of data.
The company is also planning to seek a CE mark so it can offer the scanner to countries that require the European certification.