Virtual Care Assistants for Post-Operative Recovery

A New Class of Clinical AI

• Provider-facing clinical AI supports licensed clinicians at the point of care, such as clinical decision support systems and ambient documentation tools, with responsibility and liability remaining with the provider.
• Consumer health and wellness applications deliver education, coaching, and general health guidance directly to consumers, without clinician prescription or regulation as medical devices.
• Regulated, patient-facing clinical AI. Representing a new class of clinical AI, RecovryAI's Virtual Care Assistants engage patients directly, delivering clinically validated recovery guidance and escalating deviations in recovery to licensed providers. VCAs are designed, evaluated, and governed as regulated medical devices.

Pivotal Study Reaches Last Patient Out, Supporting FDA De Novo Submission

• RecovryAI has reached last patient out in its multi-site pivotal clinical study supporting VCAs for post-procedure recovery following total joint arthroplasty (TJA).
• VCA medical reasoning is evaluated by measuring concordance between AI-generated recommendations and physician judgment across more than 43,000 real-world patient conversations.

Breakthrough Designation – What It Means for FDA Review

• Breakthrough Device Designation is reserved for medical devices that address serious conditions and represent the potential for meaningful improvement over existing standards of care for defined patient populations.
• For RecovryAI, the designation applies to its Virtual Care Assistants supporting post-procedure recovery following total joint arthroplasty.
• The designation enables earlier and more frequent engagement with the FDA during development and review, while not altering the standards required for authorization or the need for full regulatory review.

FDA Review Status

• Our pivotal clinical trial has reached last patient out: 525 patients completed the study as of July 30, 2026, and physician adjudication is now underway, with database lock and statistical analysis to follow.
• FDA engagement began in 2024 and has included multiple rigorous pre-submissions with substantial iterative engagement.
• Every AI–patient conversation in the study is independently graded by three practicing surgeons, evaluating concordance for safety at scale.
• Weekly structured qualitative assessments evaluate patient engagement and user experience.
• Breakthrough Device Designation enables prioritized FDA interaction as we advance toward De Novo Class II submission.