RecovryAI Completes Patient Phase of Pivotal Trial Evaluating Its Clinical AI in Advance of FDA De Novo Filing
With Last Patient Out today, the company concludes a 15-month, three-site study involving 525 hip and knee replacement patients and more than 43,000 AI-patient clinical conversations independently reviewed by surgeons in support of RecovryAI’s planned FDA De Novo submission.
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.
The 15-month study was conducted under institutional review board oversight at three U.S. orthopedic centers: OrthoArizona in Scottsdale, Kansas Joint & Spine in Wichita, and Mercy Medical Center in Baltimore.
A total of 525 patients completed the prospective study, generating more than 43,200 AI-patient clinical conversations for independent physician adjudication. During each interaction, the VCA evaluates whether a patient’s reported recovery is consistent with the expected postoperative course and provides appropriate guidance, or identifies a potential deviation and alerts the monitoring care team with the relevant clinical context and synthesis.
