Dual-Track
FDA Strategy
Two parallel regulatory pathways. One unified mission.
De Novo Authorization — SaMD MDDT Qualification — NAM
“The Doctor” — Patient-Facing Clinical Reasoning Engine
De Novo Authorization
Software as a Medical Device (SaMD)
Deutsch is our autonomous clinical agent that interacts directly with patients to manage cardiovascular disease. As a novel SaMD for autonomous prescription management — no predicate device exists — we pursue De Novo classification with a regulatory-first architecture.
Our strategy combines early FDA engagement (TEMPO pilot, Breakthrough Device Designation) with rigorous real-world evidence generation at safety-net hospitals, culminating in an 800-patient pivotal RCT and De Novo submission by Month 39.
UI Health, Chicago
Urban safety-net hospital, 70% minority patient population, Epic EHR integration
Second US Site
Under negotiation — expanded multi-site validation for geographic diversity
“The Regulator” — Independent Safety Supervisor
MDDT Qualification
Medical Device Development Tool — Non-Clinical Assessment Model (NAM)
Popper is our deterministic safety supervisor that validates every clinical decision before it reaches a patient. Seven safety gates run in 47ms median — no model drift, no hallucination in safety paths. We're qualifying it as an FDA MDDT to become the industry standard for clinical AI safety.
Once qualified, Popper becomes a reusable standard: other companies building clinical AI can use Popper to accelerate their own FDA clearance. Its deterministic, non-ML architecture ensures complete reproducibility and auditability.
Regulatory Timeline
39-month pathway from pre-program through authorization
Now — Month 0
- 500-patient deployment at two medical centers (May 2026)
- TEMPO SOI filed
Months 0 – 12
- 513(g) Meeting (Month 6)
- BDD Application (Month 9)
- 50+ patients at UI Health
Months 12 – 24
- Expanded validation (200+ patients at UI Health)
- FDA IDE prep
- Spanish language support
Months 24 – 39
- Pivotal RCT (N=800)
- De Novo Submission
Now — Month 0
500-patient deployment at two medical centers (May 2026). TEMPO SOI filed.
Months 0 – 12
513(g) Meeting (Month 6). BDD Application (Month 9). 50+ patients at UI Health.
Months 12 – 24
Expanded validation (200+ patients). FDA IDE prep. Spanish language support.
Months 24 – 39
Pivotal RCT (N=800). De Novo Submission.
Now — Month 0
- Popper 100% complete
- Hermes open-sourced
- 500-patient deployment with Deutsch
Months 0 – 12
- IV&V framework validated
- MDDT pre-submission meeting with FDA
- Drift detection operational
Months 12 – 24
- MDDT proposal submission
- Expanded disease policy packs
- Cross-TA1 validation
Months 24 – 39
- Full MDDT Qualification
- Industry adoption
Now — Month 0
Popper 100% complete. Hermes open-sourced. 500-patient deployment with Deutsch.
Months 0 – 12
IV&V framework validated. MDDT pre-submission meeting. Drift detection operational.
Months 12 – 24
MDDT proposal submission. Expanded disease policy packs. Cross-TA1 validation.
Months 24 – 39
Full MDDT Qualification. Industry adoption.
Key Regulatory Levers
Six strategic mechanisms accelerating the De Novo pathway
TEMPO Pilot (Filed)
Statement of Interest to FDA's TEMPO pilot (Cardio-Kidney-Metabolic track), seeking early clinician-supervised deployment at UI Health — accelerating evidence by up to 12 months.
Breakthrough Device Designation
Application at Month 9, citing urgent health equity need (46% of US counties lack a cardiologist). Priority review + interactive FDA feedback.
FDA Panel Authority
Dr. Mladen Vidovich sits on FDA Circulatory System Devices Panel (2025–2028). Ensures evidence generation meets highest regulatory standards.
PCCP
Pre-authorizes future AI/ML model updates without re-submission, preventing "regulatory lock-in." Consistent with FDA GMLP Principle 10.
DHAC Tracking
Tracking FDA's Digital Health Advisory Committee — advises on AI/ML SaMD oversight.
Pivotal RCT Design
800-patient, multi-site, pragmatic non-inferiority RCT with FDA IDE structure. 500-patient pre-program evidence at two medical centers.
Key Strategic Levers
Why Popper becomes the industry standard for clinical AI safety
Industry Standard
Once qualified, Popper becomes the recognized FDA standard for clinical AI safety supervision.
Disease-Agnostic Design
Same architecture supports HF, post-MI, diabetes, COPD, future conditions.
Open-Source Commitment
Hermes protocol (Apache 2.0, open-source since Feb 5, 2026) is the open standard for TA1–TA2 communication.
Deterministic, Not ML
Seven safety gates, 47ms median. No model drift, no hallucination. Complete reproducibility.