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Difference between revisions of "IMediSync"

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! Device ID !! Device Name !! Class !! Category !! PMA !! PMN
 
! Device ID !! Device Name !! Class !! Category !! PMA !! PMN
 
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| [https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K222838 K222838] || Normalizing Quantitative Electroencephalograph Software || 2 || Neurology || False || True
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| [https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K222838 K222838] || Normalizing Quantitative Electroencephalograph Software || 2 || Neurology || False || True
 
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| [https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K220056 K220056] || Full-Montage Standard Electroencephalograph || 2 || Neurology || False || True
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| [https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K220056 K220056] || Full-Montage Standard Electroencephalograph || 2 || Neurology || False || True
 
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|}
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==Hardware==
 +
*[[BrainScope|BrainScope]]
 
==Links==
 
==Links==
  

Latest revision as of 22:57, 17 February 2024

"iMediSync developed the first-ever sex classified EEG/HRV database and AI EEG/HRV automatic analysis cloud platform. The cloud platform iSyncBrain consists of AI automated denoising, a feature extraction pipeline from sensor level to source level, automatic quick summary reports or full reports with the database comparison, and group statistics functionality with a normative library. We completed the KFDA clinical study for our EEG screening biomarker on aMCI detection and have integrated it with the report, iSyncBrain-M1. Various collaborative research is actively undergoing to develop an EEG/HRV based biomarker for Amyloidopathy, coma prognosis, stroke rehabilitation prognosis, Parkinson pathology, depression phenotype, and determining brain lobe age for children. This will be known as the iSyncBrain-M series."


IMediSync Company Profile

Founded in South Korea around 2013, IMediSync produces noninvasive hardware and end-user software.

IMediSync makes tools for medical diagnosis and treatment through body/mind state interpretation and/or neurostimulation therapies.

BCI Categories: Open-Loop Efferent

Neurosensing Technique(s): EEG

FDA

iMediSync has 2 medical devices registered with the FDA. Here are some of them:

Examples of FDA Approved Devices ( View List)
Device ID Device Name Class Category PMA PMN
K222838 Normalizing Quantitative Electroencephalograph Software 2 Neurology False True
K220056 Full-Montage Standard Electroencephalograph 2 Neurology False True

Hardware

Links

Website Crunchbase LinkedIn LinkedIn 2 Twitter YouTube Instagram