Athletic Heart
LEGION SEALED
Athletic Heart (operating under the LEGION SEALED designation) is a fail-closed, autonomous echocardiography analysis platform on an FDA Class II device pathway. Every measurement — ejection fraction, chamber volumes, dimensions, global longitudinal strain, and Doppler E/A — is computed from actual pixels by a real imaging engine, then gated through conformal prediction, an out-of-distribution firewall, and physiologic invariants. A seven-gate safety architecture protects every diagnostic signal, and a hash-chained regulatory-evidence ledger preserves the audit trail. Independently re-verified by an adversarial AI QA harness.
/Capabilities
Seven-Gate Safety
Signal quality, calibration, consent, and confidence gates must all pass — a single failure blocks diagnostic emission.
Fail-Closed by Default
The system defaults to non-emission. Ambiguous studies route to human review rather than risk a false read.
Regulatory-Evidence Ledger
Every diagnostic decision is chained into a hash-verified ledger that preserves evidentiary integrity for regulatory review.
Adversarial QA
An independent adversarial harness re-verifies the platform against seeded defects, with a 1:1 catch requirement.
- Real pixel-measurement engine
- Conformal prediction + OOD firewall
- Seven-gate safety architecture
- Hash-chained evidence ledger
- FDA Class II pathway
- Fail-closed diagnostics
- Seven-gate safety architecture
- Hash-chained regulatory evidence
- Adversarial re-verification