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Syncthink fda

WebSyncThink is a fast, reliable, and mobile solution that provides objective data to help medical professionals make better decisions about treatment. Cantina worked closely with … Web10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA

SyncThink’s Marketing Claims Raise Questions mddionline.com

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, … 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 … childrens outdoor toys https://foreverblanketsandbears.com

Eye-Sync - Virtual Reality, Augmented Reality Wiki - VR AR & XR Wiki

Web맞춤형 r&d 연구자문; 특허·기술 사업화 지원; 시험검사·비임상 지원; 인허가·규제대응; 시장진출 지원; 임상학회 자문 WebMay 30, 2024 · As previously reported, FDA granted SyncThink a breakthrough device designation in February 2024 for Eye-Sync. As a point of clarification for our readers, FDA's breakthrough device designation program allows companies to have more frequent and less formal interactions with senior FDA reviewers. 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. § childrens outdoor toys nz

Eye-Sync - Virtual Reality, Augmented Reality Wiki - VR AR & XR Wiki

Category:SyncThink Receives Second FDA Clearance for Mobile, Rapid

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Syncthink fda

SyncThink, Inc. - 498523 - 07/31/2024 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 · SyncThink, a neurotechnology company and developer of the EYE-SYNC technology, has received clearance from the Food and Drug Administration (FDA) for the …

Syncthink fda

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WebMar 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 … 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 …

WebEye-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. 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 …

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 … 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 algorithm of its own to ...

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. government syphilis experimentWebFeb 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 ... childrens outdoor toys for boysWebDec 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: … government syllabus for jamb 2023WebMar 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 … children south entWebFeb 21, 2024 · SyncThink is a Silicon Valley company that has developed a technology that may become a standard way of care to diagnose concussions. The FDA has granted Breakthrough Device Designation to the ... government symbolWebOct 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. childrens outdoor table and chairsWebOct 5, 2024 · FDA Clears First Mobile Rapid Test for Concussion. The US Food and Drug Administration (FDA) has cleared SyncThink's Eye-Sync technology to aid in the diagnosis of mild traumatic brain injury, the ... childrens outdoor toys sale