Syncthink fda
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. § WebOct 8, 2024 · Palo Alto, Calif.-based SyncThink has received a further 510(k) clearance from the FDA for its Eye-Sync technology as an aid in diagnosing concussion or mild traumatic brain injury. The eye-motion tracking system uses artificial intelligence to identify concussions without the need for a baseline test. A recent study showed that Eye-Sync …
Syncthink fda
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WebAug 10, 2024 · FDA-cleared for detecting eye-tracking impairments and as an aid to concussion diagnosis, EYE-SYNC is used by leading medical centers such as Stanford and … WebJan 4, 2024 · In fact, SyncThink, which works with sports teams like the Golden State Warriors, has previously been reprimanded by the FDA for promoting its device as a way to detect concussions.
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 … 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, …
WebJun 18, 2024 · An FDA clearance is necessary to market a medical device in the United States. Everyone is aware that regulatory hurdles can be an expensive, intrusive process. Having one carries a lot of weight. However, few companies have been through the process and rarely discuss the challenges. But there are benefits to transparency. Users of … 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 ...
WebOct 5, 2024 · SyncThink develops revolutionary eye-tracking software and analytic technologies, delivered in a rapid, accurate, and easy to use medical XR platform. With …
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 … エクセル wscript.shellWebOct 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 … palmo delle mani rosse causeWebOct 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, ... エクセル xelWebSyncThink, Inc. Aug 2024 - Present4 years 7 months. San Francisco Bay Area. Compliance Officer - FDA, Quality Management System (QMS), HIPAA, Electrocompatability, Biocompatability. Successfully ... エクセル xlfn.concatWeb맞춤형 r&d 연구자문; 특허·기술 사업화 지원; 시험검사·비임상 지원; 인허가·규제대응; 시장진출 지원; 임상학회 자문 palmo delle maniWebMar 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 … エクセルxlookupWebAug 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. エクセル _xlfn.let