WebOct 7, 2024 · Eye-Sync -- a virtual reality system from neurotechnology company SyncThink that uses eye-tracking data to evaluate brain function -- has been granted Aid to Concussion, or mild Traumatic Brain Injury (mTBI) Diagnosis, status by the FDA. Eye-Sync was previously given Breakthrough Device Designation from the FDA in 2024, making this SyncThink ... WebFeb 24, 2024 · The FDA intends to request any other information needed to inform the Breakthrough Device designation decision within 30 days of receiving your request. ... SYNCTHINK, INC. EYE-SYNC: K202927: 10 ...
Blog: Behind an FDA Clearance - NeuroSync - SyncThink
WebSyncThink, Inc. EYE-SYNC 510(k) Owner SyncThink, Inc. 54 Canal Street Suite 200 Boston, MA 02114 Submission Correspondent Maureen O’Connell O’Connell Regulatory … WebAug 11, 2024 · Magic Leap and SyncThink actually began working together back in 2024. FDA initially cleared the Eye-Sync platform in March 2016 for recording, viewing, and analyzing eye movements to help clinicians identify visual tracking impairment. VR and AR technology is increasingly finding a home in healthcare. books on murder investigation
SyncThink Receives Second FDA Clearance For EYE-SYNC …
WebFeb 20, 2024 · Image and thumbnail have been resized. Courtesy of SyncThink.. Eye-Sync, an objective eye-tracking platform created by SyncThink, a neurotechnology and brain health analytics company, has received breakthrough device designation from the U.S. Food and Drug Administration (FDA) today. Webwww.fda.gov October 2, 2024 SyncThink, Inc. ℅ Allison Kumar Regulatory Consultant Arina Consulting, LLC 27 Hilltop Dr San Carlos, California 94070 Re: K202927 Trade/Device … WebBabak joins the SyncThink team in 2024 as the Technical Lead. ... Allison has more than 15 years of regulatory experience, with 10 years at the FDA and over 5 years in the medical device and biotech industry. At FDA, Allison provided specialized and … books on m theory