EMvision Medical Devices Limited submitted a 513(g) Request for Information to the United States Food and Drug Administration (FDA). The purpose of this submission is to seek guidance from the FDA on what product classification would be most appropriate for company's next generation portable brain scanner device and what the appropriate regulatory pathway will be. The Company is in dialogue with the FDA, the FDA is aware that its response is overdue, and the company anticipates the response from the FDA no later than early 2021. As previously advised, the Company has submitted a 513(g) Request for Information to the United States Food and Drug Administration (FDA). The purpose of this submission is to seek guidance from the FDA on what product classification would be most appropriate for EMVision's next generation portable brain scanner device and what the appropriate regulatory pathway will be. The Company is in dialogue with the FDA, the FDA is aware that its response is overdue, and the Company anticipates the response from the FDA no later than early 2021.