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RocSite, Inc. builds and validates clinical AI on FDA-track pathways with pre-registered methodology and null-result transparency. Three products. Published research. No outside capital.
FDA Pre-Submission accepted, January 2026, for ICH Triage (Class II SaMD).
See ICH Triage →Pre-registered medical AI safety research, published with null-result transparency.
Read the study →Independent adversarial validation. Clinical AI outputs are compared against established peer-reviewed clinical scoring instruments appropriate to the condition under evaluation, with cryptographic attestation of every comparison. The point is to disprove the model on cases that matter, not to celebrate it on cases that don't.
FDA-track clinical AI. ICH Triage is an offline AI device for detecting intracranial hemorrhage in head CT scans. It runs on hospital infrastructure with no PHI transmitted. FDA Pre-Submission was accepted in January 2026 on the Class II SaMD pathway.
Peer-reviewable methodology. The sepsis falsification study (286,510 ICU patients across MIMIC-IV and eICU-CRD) was pre-registered before any data access. The hypothesis was locked. The primary cohort returned a null result. We published it anyway. Read the study →
Offline AI device for detecting intracranial hemorrhage in head CT scans. FDA Pre-Submission accepted January 2026 (Class II SaMD pathway). Working ICU physicians have used the demo and exhausted trial allocations in single sessions.
See ICH Triage →Independent adversarial validation methodology for clinical AI outputs, with cryptographic attestation across 21 active modalities (19 deterministic clinical scoring specialists plus chest X-ray and head CT vision pipelines). Not a medical device. Purpose-built to support FDA-regulated AI vendors and the institutions that deploy them.
See AI Governor →Adversarial pharmacovigilance. Drug-safety claims are validated against FAERS using regulatory-standard disproportionality math (PRR with confidence intervals), then signed and chained to a public ledger. Operated by RocSite Discovery.
See Caliper at RocSite Discovery ↗Hypothesis generation across large clinical datasets, contradiction surfacing, and methodology-audit research. Part of the RocSite Discovery toolset, alongside AI Governor and Caliper.
See Discovery at RocSite Discovery ↗21 years at IBM, an IBM Certified Architect, the top of IBM's architect ladder, validated through Open Group certification. Architected petabyte-scale media systems in 2007, when most companies were still measuring in terabytes. Regulated IT experience at Johnson & Johnson. Built and sold a successful real estate brokerage. Founded RocSite to apply 30 years of complex-systems experience to medical AI safety.
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Related work and products operated by RocSite, each with its own team, site, and audience.