Clinical evidence.
FDA clearance.
Real clinical use.
Gesund supported the expert validation and evidence work behind Prenuvo’s Body Composition AI clearance.
Prenuvo now offers the FDA-cleared analysis to patients at participating clinics. Its broader clinic network spans North America, Europe and Australia.
Discuss your study ↗Expert evidence for
Body Composition AI.
Gesund’s case study describes coordinated radiologist review and structured evidence generation, alongside testimony from Prenuvo’s regulatory and quality leadership.
FDA recorded a substantial-equivalence decision for Prenuvo Body Composition on January 17, 2025.
Inspect the FDA device record ↗Part of a growing
clinical offering.
Prenuvo markets Body Composition Analysis as an FDA-cleared AI offering. Its September 2026 announcement reports 26 clinics across North America, Australia and Europe.
Body Composition availability is clinic- and market-specific; Prenuvo’s July 2026 availability page lists participating US clinics and exclusions. The network total is not a count of installations of this particular AI product.
Current Body Composition offering ↗