Syncthink fda
WebFeb 19, 2024 · February 19, 2024 FDA Grants SyncThink’s EYE-SYNC Platform Breakthrough Device Designation for Aid to Concussion Assessment. Palo Alto, CA—February 19, … 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 …
Syncthink fda
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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 … WebSep 9, 2024 · The FDA has reviewed your firm’s website at www.syncthink.com and determined that the EYE-SYNC device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. §
Web맞춤형 r&d 연구자문; 특허·기술 사업화 지원; 시험검사·비임상 지원; 인허가·규제대응; 시장진출 지원; 임상학회 자문 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 …
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 … WebOct 10, 2024 · The FDA cleared the device to record, view and analyze eye movements for identifying visual tracking impairment in patients. ... is carving a niche in eye-tracking testing for vision impairment. Other names in the space include SyncThink, which received 510(k) clearance for its Eye-Sync device in 2016, and Neuro Kinetics, ...
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 …
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 … sewing magazines subscriptionsWebOct 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 ... sewing magazines freeWebAug 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. sewing madison wiWebOct 7, 2024 · SyncThink, a next gen neurotechnology company and developer of the award-winning EYE-SYNC technology, announced the U.S. Food and Drug Administration (FDA) … the t\u0026m groupWebAug 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 … sewing magazine subscriptionsWebMar 9, 2024 · SyncThink and the EYE-SYNC technology received its second FDA Clearance in 2024 as an Aid to Concussion Diagnosis, or mild Traumatic Brain Injury (mTBI) Diagnosis. It combines proprietary software and data analytics with high performance eye tracking sensors to measure and quantify eye movement biomarkers reflective of impairment or … the tu-104WebEye-Sync Package Specification. 01.Comprehensive brain health solution, including EYE-SYNC eye tracking, vestibular screening (investigational use only), and SCAT5. 02.FDA-cleared for detecting eye tracking impairment. 03.Fast, reliable, objective metrics within a minute. 04.Cloud connected with export PDF functionality. the tu-160