EMVision Medical Devices (ASX:EMV) has received valuable insights and guidance from the FDA on its planned validation trial to support a De Novo regulatory clearance pathway.
A consultative meeting with the FDA was held as part of EMVision's planned validation trial preparation via the FDA's Q-submission programme, a mechanism whereby industry may gain alignment with FDA prior to final regulatory submission.
CEO and Managing Director, Scott Kirkland, said the meeting answered a number of critical questions relating to the company’s validation programme, including key parameters of the validation study, sites outside the US and statistical powering. A synopsis of the validation trial is provided below.
“The meeting reinforced our confidence that EMVision’s strategic direction is appropriately aligned with FDA requirements. EMVision will continue to engage with the FDA to ensure alignment up to regulatory submission. We are preparing ethics as well as contracts and other administrative elements with activation anticipated in the coming months.
“EMVision’s leadership is visiting US investigational sites for advanced site engagement, including preliminary device training, prior to participating at the Society of Vascular and Interventional Neurology (SVIN) annual meeting in November.
“Announcement of sites to follow in due course. In parallel, human factors engineering studies are in process to extend usability to the range of potential intended users and use environments.”