WebOct 8, 2024 · SyncThink, a neurotechnology company and developer of the EYE-SYNC technology, has received clearance from the Food and Drug Administration (FDA) for the EYE-SYNC technology as an aid to concussion, or mild Traumatic Brain Injury (mTBI) Diagnosis. Expand. EYE-SYNC previously received Breakthrough Device Designation from … WebContact Email [email protected]. Phone Number (650) 727-1819. SyncThink is a leading neuro-technology company with foundational IP in eye-tracking analytics and devices. The …
Neurotech company will use Magic Leap 2 for dizziness
WebAug 15, 2024 · Boston, Mass.-based SyncThink has received a CE mark for its Eye-Sync digital health platform. The system combines the company’s proprietary software with eye tracking sensors to track eye movements that indicate neurological impairment or disease, delivering results in less than a minute. Eye-Sync received an FDA clearance in 2024 as an … 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 … homeostase feedback negativo
Breakthrough Devices Program FDA
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 ... WebSyncThink, Inc. Aug 2024 - Present4 years 7 months. San Francisco Bay Area. Compliance Officer - FDA, Quality Management System (QMS), HIPAA, Electrocompatability, Biocompatability. Successfully ... WebJul 31, 2024 · SyncThink, founded in 2009, is aiming to provide an example of how rehabilitation after sports injuries is changing due to cutting-edge technologies. The Eye-Sync device, developed by Silicon Valley neuro-technology company SyncThink, was granted US Food and Drug Administration (FDA) designation as a breakthrough device earlier this … hinkley health hpc