RecovryAI Completes Patient Phase of Pivotal Trial Evaluating Its Clinical AI in Advance of FDA De Novo Filing
RecovryAI, a clinical AI company developing patient-facing Virtual Care Assistants (VCAs) for postoperative recovery, today announced that its prospective pivotal study has reached last patient out, marking the completion of patient participation and clinical data collection.
RecovryAI Announces FDA Breakthrough Device Designation for Patient-Facing Clinical AI
RecovryAI today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its Virtual Care Assistants (VCAs), physician-prescribed, patient-facing clinical AI designed to support patients during post-operative recovery. The designation, reserved for medical devices that address serious conditions and demonstrate the potential to meaningfully improve existing standards of care, enables earlier and more frequent engagement with the FDA while maintaining the full requirements for demonstrating safety and reliability. The milestone coincides with RecovryAI’s emergence from stealth following more than two years of product development and clinical evaluation.
