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Syncthink fda

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 … 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 …

2024 > SyncThink, Inc. 7/31/17

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 ... 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 … eiffel tower cardboard template https://neisource.com

Blog: Behind an FDA Clearance - NeuroSync - SyncThink

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. 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 … 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. follow me olaf replacement remote

SyncThink Receives Second FDA Clearance for EYE-SYNC …

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Syncthink fda

Neurotech company will use Magic Leap 2 for dizziness

Webwww.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), … 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 …

Syncthink fda

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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. 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 …

WebThe 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. § … 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, Inc. EYE-SYNC 510(k) Owner SyncThink, Inc. 54 Canal Street Suite 200 Boston, MA 02114 Submission Correspondent Maureen O’Connell O’Connell Regulatory … 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 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) …

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 … follow me olaf toyWebDec 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: … follow me now lyricsWebOct 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 … follow me on hoverWebFeb 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. follow me olaf in stockWebSyncThink 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 ... follow me mytWebOct 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, ... follow me on facebook gifWebOct 6, 2024 · This week SyncThink landed FDA clearance for its digital AI-backed system, called the EYE-SYNC, to be used as an Aid to Concussion or mild Traumatic Brain injury … eiffel tower cat\u0027s cradle