Precoh

health AI regulatory technologyhealth tech

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StageNot publicly available

YC batchNot mentioned/Not applicable

RaisedNot publicly available

Founded2021

Employees2

LocationAtlanta, GA

ValuationNot publicly available

About

Precoh is the regulatory infrastructure layer for clinical AI. We convert FDA SaMD, EU MDR, and IMDRF requirements into a single executable pipeline (RegOS) producing a SHA-256 tamper-evident audit trail that regulatory teams, legal teams, and boards can stand behind. RegOS produces a weighted composite score across five domain engines — Data Governance, Clinical Validation, Fairness & Bias, Technical Standards, and Post-Market Governance — with transparent approval thresholds. For autonomous clinical AI, we apply an additional MD Comparison Evaluation: any system that cannot demonstrate performance relative to a physician baseline on the intended use population should not pass regulatory decision regardless of domain scores. Trusted by government health regulators and health systems clinical AI programs across three continents. → Run a free AI Readiness Assessment:

Product

Value proposition: Combines expert advisory with the RegOS platform to deliver a structured, reproducible, auditable regulatory pipeline from evaluation to submission-ready evidence for clinical AI models.
Target customers: health systems, AI labs, regulators

Founders

Michael W. Craige — Founder & CEO
Calvin Terry — CTO & Data Security Officer

Products

RegOS platformexpert advisory services for clinical AI readiness

Key features

Structured intake & multi-domain validationFDA SaMD & EU MDR aligned scoringTamper-evident audit trailSubmission-ready evidence packagesReproducible, auditable pipelines from evaluation to submission

Technologies

RegOS platformregulatory execution pipelinetamper-evident audit trailsdomain engines (Data Governance, Clinical Validation, Fairness & Bias, Technical Standards, Post-Market Governance)SHA-256 tamper-evident records

Certifications

HIPAA compliant

Notable customers

Top-5 Academic Medical Center5-Hospital Mid-Atlantic NetworkGovernment Health Sandbox — 3 Continents

Traction metrics

247+ evaluations run

News

Presenting at Veeva MedTech Summit: AI in MLR - LinkedIn · 2026-04-13T00:00:00.000Z
Precognitive | Enhance Care Now – Learn More · 2025-06-20T00:00:00.000Z
Predoc Raises $30M to Launch AI-Native Platform for Health Information Management · 2025-09-02T18:34:27.000Z
Oncologists Say Cancer Care Starts Too Late - PreOncology™ Launches New Medical Specialty Focused on Finding Cancer Before Stage I · 2026-07-01T12:00:00.000Z

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Profile updated Jul 29, 2026. Sources: precoh.ai, linkedin.com