Finalize physician review and complete the clinical dataset
Target Q4 2026
Statistical Analysis
Test results against pre-specified performance goals
Target Q4 2026
Final FDA Interactions
Additional Pre-Sub round(s) as needed
Resolve remaining questions before filing
Target Q4 2026
De Novo Submission
Class II SaMD submission package to FDA
Target 2027
FDA Review
Substantive review of safety, effectiveness, software, labeling, and risk controls
Target Q2 2027
Potential FDA Authorization
If granted, RecovryAI becomes first-of-kind in a new Class II category
Illustrative regulatory timeline. Targets and timing are subject to change. FDA authorization is not guaranteed. The Virtual Care Assistant is an investigational device, limited by law to investigational use, and has not been authorized for commercial use.