EMvision Medical Devices Limited communicated the guidance received from the FDA regarding the regulatory requirements applicable to EMVision's portable brain scanner. The FDA has recommended that the appropriate regulatory pathway for the EMVision portable brain scanner is the De Novo process. The De Novo pathway is designed for low to moderate-risk, products and employs a risk-based strategy for evaluating applications. It is used for new, novel devices without previous classification that are likely classified, based on their intended use and risk profile, as class II (same as MRI, ultrasound and CT) and for which there is no immediate comparable device. The Company will engage with the FDA to confirm the required evidence including the planned clinical performance data necessary to support a De Novo submission as well as an application for the FDA's "breakthrough device program". The breakthrough program aims to speed development and assessment of devices that promise a more effective treatment or diagnosis for a life-threatening or irreversibly debilitating conditions. The Company intends to submit an application for breakthrough device designation, acceptance into this program is not guaranteed.