marketing-medtech

**Founder:** Jean-François Paul — President / CEO & Founder
**Background:** clinician | verified: True — Radiologist (physician / clinician). Jean-François Paul is a radiologist and researcher with 25+ years of clinical experience in Cardiac CT and MR at Marie Lannelongue Hospital, Institut Mutualiste Montsouris (IMM), and the American Hospital of Paris. He is Chief of Cardiac Imaging (CT and MR) at Institut Mutualiste Montsouris, Paris, author/co-author of 150+ peer-reviewed publications, and CEO & Founder of SPIMED-AI. The "clinician" claim is accurate — a radiologist is a practicing physician.
**Stage / fundraise:** Early-stage, capital-light SaMD scale-up. Founded 5 Sept 2019 (SAS, Paris 75014), so older than the 24-month ICP window, but still under-resourced and actively raising — multiple small capital openings recorded in 2026 (Jan/Apr/Jun 2026). Revenue still nominal (~€15k CA in 2024). / Funded but thin: >€500k crowdfunding from radiologists/cardiologists + BPI seed loan, ongoing 2026 capital openings, ~€15k CA in 2024.
**Regulatory trigger:** High-value, time-pressured. CorEx is currently CE-marked under the OLD MDD (Medical Device Directive), not MDR. MDD certificates are expiring under the EU transition timeline, so SPIMED-AI must move CorEx onto EU MDR. As an AI diagnostic SaMD, CorEx falls under MDR Rule 11 and very likely up-classifies to Class IIa+, demanding full IEC 62304 software-lifecycle evidence, technical documentation, clinical evaluation and a Notified Body audit. Add stated US/worldwide (FDA) ambitions, the EU AI Act for high-risk medical AI, and a French reimbursement path — all of which need a defensible engineering + compliance trail.
**Email:** jean-francois@spimed-ai.com (confidence medium) — RocketReach lists the founder with masked pattern j******@spimed-ai.com on the spimed-ai.com domain, consistent with firstname@. Website uses a contact form only, so this is a confirmed-pattern guess (medium), not a published address.
**LinkedIn:** https://fr.linkedin.com/in/jean-francois-paul-22054860 **Website:** https://www.spimed-ai.com/
**Score:** 10 -> Tier B
**Hook:** CorEx is already CE-marked — but under the old MDD, and as an AI diagnostic it almost certainly up-classifies under MDR Rule 11, so the next 12-18 months are an MDR re-certification + IEC 62304 lifecycle exercise on top of a US/FDA push, exactly when a crowdfunded, clinician-led team has no named CTO and is still hiring. OmDev gives Dr Paul a senior dev squad plus a dedicated CTO at a fixed monthly price ~3x cheaper than building that team in-house, and our pipeline produces the compliance evidence (SOUP register signed every build, requirements-to-code-to-test traceability) that feeds the IEC 62304/MDR technical file — turning the MDR cliff into a managed, audit-ready deliverable while he keeps the code and stays focused on the clinical science.

---

## Founder & background
Jean-François Paul is President / CEO & Founder of SPIMED-AI and a cardiovascular/cardiac-imaging radiologist with 20-25+ years in cardiac CT/MR (Marie Lannelongue, Institut Mutualiste Montsouris, American Hospital of Paris; trained at HEGP) ([LinkedIn](https://fr.linkedin.com/in/jean-francois-paul-22054860)).
He is the registered dirigeant since 10 Sept 2019 ([Pappers](https://www.pappers.fr/entreprise/spimed-ai-853720696)); founding team includes Henri Giroussens, Théophile Adouard and Tanig Paradot.
Clinician tier: deep clinical/technical credibility, **no finance or insurance background** stated anywhere — and no named CTO on the team.
**Why OmDev fits:** a clinically brilliant, non-engineering-led founder needs a senior dev team + dedicated CTO he doesn't have to recruit.

## Funding & momentum
Funded but capital-light: raised **>€500k via crowdfunding** from radiologists/cardiologists for Coronary-Expert/CorEx, plus a **BPI seed loan** ([BPI post](https://www.spimed-ai.com/post/pr%C3%AAt-d-amor%C3%A7age-bpi)).
Still raising — several small **capital openings recorded in 2026** (Jan/Apr/Jun) and revenue only ~€15k CA in 2024 ([Pappers](https://www.pappers.fr/entreprise/spimed-ai-853720696)).
Strong recognition (i-Lab / Concours d'innovation laureate, JFR 2023 innovation prize, French Healthcare member ([FrenchHealthcare](https://frenchhealthcare.fr/membres/spimed-ai/))) — credible, but not a deep balance sheet for a regulated build.
**Why OmDev fits:** fixed monthly price ~3x cheaper than in-house lets a crowdfunded team buy a full squad without burning the raise.

## Product & regulatory
CorEx (Coronary-Expert): AI SaMD that reads CCTA, classifies coronary lesions per CAD-RADS and estimates lesion-related FFR in <1 min; clinically validated (FFRai AUC ~0.93) ([Product](https://www.spimed-ai.com/product), [Health AI Register](https://radiology.healthairegister.com/products/spimed-ai-corex/)).
Critical trigger: CorEx is CE-marked **under the old MDD, not MDR** ([Product page](https://www.spimed-ai.com/product)) — MDD certificates are expiring, so it must transition to **MDR**, where an AI diagnostic up-classifies under Rule 11 (likely Class IIa+), demanding full **IEC 62304** lifecycle evidence, clinical evaluation and a Notified Body audit.
Add stated US/worldwide (FDA) ambitions and the EU AI Act for high-risk medical AI — all needing a defensible engineering + compliance trail.
**Why OmDev fits:** our pipeline emits a SOUP register signed every build + requirements-to-code-to-test traceability that drops straight into the IEC 62304/MDR technical file (OmDev does not certify).

## Pain & buying signals
No named CTO; clinician-led founding team and a website actively advertising **Job Opportunities** (hiring engineers) ([spimed-ai.com](https://www.spimed-ai.com/)) — engineering-thin and capital-light versus an MDR re-certification cliff plus US expansion.
Email pattern confirmed via RocketneReach masked listing j******@spimed-ai.com ([RocketReach](https://rocketreach.co/jean-francois-paul-email_98787719)); reach also via the site contact form.
The clinically deep founder / shallow eng-and-compliance bench mismatch is the core gap.
**Why OmDev fits:** dedicated CTO + senior devs + compliance engine turns the MDR cliff into an audit-ready deliverable while Dr Paul keeps the code and stays on the clinical science.

---
**Sources:** https://www.spimed-ai.com/ · https://www.spimed-ai.com/product · https://www.pappers.fr/entreprise/spimed-ai-853720696 · https://fr.linkedin.com/in/jean-francois-paul-22054860 · https://fr.linkedin.com/company/spimed-ai · https://rocketreach.co/jean-francois-paul-email_98787719 · https://radiology.healthairegister.com/products/spimed-ai-corex/ · https://frenchhealthcare.fr/membres/spimed-ai/ · https://www.spimed-ai.com/post/pr%C3%AAt-d-amor%C3%A7age-bpi · https://annuaire-entreprises.data.gouv.fr/entreprise/spimed-ai-853720696