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Syncthink fda

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 EYE-SYNC technology as an aid to concussion, or mild Traumatic Brain Injury (mTBI) Diagnosis. Expand. EYE-SYNC previously received Breakthrough Device Designation from … 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 …

Neurotech company will use Magic Leap 2 for dizziness

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 … 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 … homeostase feedback negativo https://mcpacific.net

Breakthrough Devices Program FDA

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 ... WebSyncThink, Inc. Aug 2024 - Present4 years 7 months. San Francisco Bay Area. Compliance Officer - FDA, Quality Management System (QMS), HIPAA, Electrocompatability, Biocompatability. Successfully ... 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 … hinkley health hpc

Augmented Reality and Virtual Reality in Medical Devices FDA

Category:SyncThink Receives Second FDA Clearance for Mobile, Rapid ... - Eyewire+

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Syncthink fda

Eye-Sync Granted FDA Breakthrough Device Designation for AI Eye …

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 … 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 …

Syncthink fda

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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. § 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.

Web10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA 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 ...

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 … 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.

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 RightEye, LLC Adam Gross Chief Executive Officer 7979 Old Georgetown Rd., Suite 801 Bethesda, Maryland 20814 ... The predicate device is the EYE-SYNC (K152915), … hinkley heritage lightingWebSyncThink, Inc. 54 Canal Street Suite 200: Boston, MA 02114 Applicant Contact: Daniel Beeler: Correspondent: O'Connell Regulatory Consultants, Inc. 5 Timber ... MD 20993 Ph. 1 … homeostase marathonWebOct 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 … hinkley high school athleticsWebThe 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. § … hinkley high school calendarhomeostasis adaptationWebOct 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 ... homeostase intestinalWebAug 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. homeostasis anchor chart