EMVision Medical Devices (ASX:EMV) has advised that it has received insights and guidance from the US FDA on its planned validation trial to support the emu de novo regulatory clearance pathway.
The company said a consultative meeting with the US FDA was held as part of its planned validation trial preparation. The meeting was held via the FDA's Q-submission program, a mechanism whereby the industry may gain alignment with the FDA before final regulatory submission.
EMVision said the meeting answered several critical questions relating to its validation program, including key parameters of the validation study, sites outside the US and statistical powering.
The company said the meeting reinforced its confidence that its strategic direction appropriately meets FDA requirements. It is preparing ethics, contracts, and other administrative elements, with activation anticipated in the coming months.
The company said its leadership is visiting US investigational sites for advanced site engagement, including preliminary device training, before participating at the Society of Vascular and Interventional Neurology (SVIN) annual meeting in November.