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Food and Drug Administration FDA published a Warning Letter to RightEye, LLC RightEye manufacturer of RightEye Vision System, for misbranding and adulteration. RightEye Vision System is a Class II Nystagmograph medical device which is cleared under its 510k.
An FDA inspection claimed that eye-tracking biomarker developer RightEye misbranded and adulterated its medical device.
On January 31, 2023, the U.S. Food and Drug Administration (FDA) published a Warning Letter to RightEye, LLC (RightEye), the manufacturer of the RightEye Vision System, for misbranding...
CDC Reports Lyme Disease Cases Tripling. Current Testing Methods Have Significant Shortcomings...
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