
3D wound modeling, trend analytics, and explainable guidance that fit existing workflows.
Under development; not for diagnostic use.
Illustrative UI—no patient data. Not for diagnostic use.

Designed to reduce burden, improve measurement consistency, and support better outcomes—without replacing professional judgment.
Automated surface and volume estimates to reduce measurement variance.
Longitudinal views, risk flags, and response-to-care tracking.
Patient Q&A transformed into structured, chart-ready output.
FHIR-friendly, CSV/JSON formats to minimize double-charting.
HIPAA-aligned design, encryption, RBAC, and audit logging.
Transparent guidance with citations and override capability.
Bedside image capture with guided positioning
Automated metrics and wound characterization
Clinician review and approval with override options
Direct integration with EHR systems
Rigorous validation with partner sites to ensure clinical fit and performance.
Bedside capture → metrics → draft note → review → export
Measurement consistency, documentation time, workflow fit
Wound centers, inpatient consults, VA/DoD, SNF
Illustrative targets; finalize with partner sites & IRB.
Decision-grade milestones toward clinical validation and market access. Exit criteria guide each phase transition.
Bench + synthetic/phantom validation; core UX hardening; design inputs drafted.
Measurement workflow stable; preliminary variance targets set; pilot LOIs gathered.
IRB/ethics package, DUA/BAA, design controls kickoff, data mgmt & de-ID SOPs, IFU v0.5.
Site onboarding complete; training plan approved; pilot protocol ready to execute.
Multi-site observational data collection; V&V; predicate mapping for 510(k).
Pre-specified endpoints met; V&V report; submission dossier assembled.
Early access cohorts; reference sites; support/readiness; post-market surveillance plan.
Go-live checklist passed; support SLAs in place; PMCF/PMS plan active.
• Timeline is illustrative; regulatory clearance not yet obtained.
• No patient data shown.
• Performance metrics represent targets pending validation; no efficacy claims until clinical studies complete.
We're building assistive AI tools to reduce clinician burden, improve measurement consistency, and support better patient outcomes—without replacing professional judgment.
Built to fit existing systems and workflows
Transparent outputs with traceable reasoning
HIPAA-aligned architecture and data handling
Co-developed with frontline clinicians
Interested in early access or partnership? We'd love to hear from you.
Or email:
brian.helewa@inovasity.io