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Syncthink fda

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 ... 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 ...

Blog: Behind an FDA Clearance - NeuroSync - SyncThink

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 … WebAug 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. books on murder investigation https://paradiseusafashion.com

SyncThink Receives Second FDA Clearance For EYE-SYNC …

WebFeb 20, 2024 · Image and thumbnail have been resized. Courtesy of SyncThink.. Eye-Sync, an objective eye-tracking platform created by SyncThink, a neurotechnology and brain health analytics company, has received breakthrough device designation from the U.S. Food and Drug Administration (FDA) today. 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 … 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 … books on m theory

SyncThink - Crunchbase Company Profile & Funding

Category:January 29, 2016 - Food and Drug Administration

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Syncthink fda

Neurotech company will use Magic Leap 2 for dizziness

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 … 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 …

Syncthink fda

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WebJan 13, 2024 · SyncThink already has FDA clearance for an eye-tracking VR device that helps diagnose concussions. Changes in eye movements are also linked to vestibular … 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

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 … 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. §

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 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 ...

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 ... harvey winter dds albany nyWebOct 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. harvey wippleman action figureWebOct 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) … harvey winstein troublesWebDec 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: … harvey winnipegWebAug 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 … harvey wippleman net worthWebwww.fda.gov RightEye, LLC Adam Gross Chief Executive Officer 7979 Old Georgetown Rd., Suite 801 Bethesda, Maryland 20814 ... The predicate device is the EYE-SYNC (K152915), … books on mushrooms in north americaWebApr 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 … books on mushroom identification