Syncthink fda
WebApr 10, 2024 · SyncThink, Inc. 2172 Staunton Court: Palo Alto, CA 94306 Applicant Contact: Dan Beeler: Correspondent: Arina Consulting, LLC: 27 ... MD 20993 Ph. 1-888-INFO-FDA (1 … 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 …
Syncthink fda
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WebDec 7, 2024 · The FDA is providing this list of medical devices that incorporate AR/VR marketed in the United States as a resource to the ... SyncThink, Inc. Neurology: GWN: …
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 5, 2024 · SyncThink, a next gen neurotechnology company and developer of the award-winning EYE-SYNC technology, announces today the US Food and Drug Administration (FDA) has granted clearance of the EYE-SYNC technology as an Aid to Concussion, or mild Traumatic Brain Injury (mTBI) Diagnosis.
WebSyncThink, Inc. Aug 2024 - Present4 years 7 months. San Francisco Bay Area. Compliance Officer - FDA, Quality Management System (QMS), HIPAA, Electrocompatability, Biocompatability. Successfully ... WebFDA-cleared for detecting eye tracking impairment and used by leading medical centers such as Stanford and Massachusetts General, the U.S. military, and more than 20 top universities, SyncThink is transforming assessment, recovery, and performance for life and sport. www.syncthink.com Read More. Contact
WebSyncThink isn’t the only medtech developer attempting to clear the thorny pathway to concussion diagnosis. BrainScope, for one, added an FDA-cleared, concussion-detecting …
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 … margarita sloane solicitorWebEye-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. margarita solacheWebContact 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 … culina ristorante and caffèWebJul 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 … margarita society dallasWebSep 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. § margarita sofianovaWebOct 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) … culinary chlorella starchWebMar 21, 2024 · SyncThink has received FDA clearance for its EYE-SYNC technology as an aid to concussion, or mild traumatic brain injury (mTBI) diagnosis. EYE-SYNC received … culinary capital definition