marketing-medtech

**Source:** GetYourJob (classified health-software, actively hiring developers)
**Founder:** Cécile Dupont Redon — CEO & Co-founder
**Background:** pharma_medtech_exec | verified: True — Cécile Dupont Redon is a medtech (medical device) executive. She is CEO of BrightHeart (an AI medtech company for congenital heart defect screening) and a Partner at Sofinnova Partners (life-sciences VC), in the MD Start medtech incubation program. Her prior roles are all in medical devices/medtech: CEO of HEPTA Medical, COO of Gradient Denervation Technologies, Director of Clinical, Regulatory and Market Access at SafeHeal, plus earlier clinical, marketing and regulatory positions across endoscopy, pulmonology, dermatology, surgery and diabetes-care device companies. Education: biomedical engineering (UTC) and corporate finance (HEC Paris). This solidly matches a 'medtech exec' profile. Note: the background label 'pharma_medtech_exec' is best described as MEDTECH/medical-device, not pharmaceutical specifically. Also note her CEO title is confirmed, but she is generally listed as CEO rather than co-founder (co-founders cited are Marilyne Levy MD, Bertrand Stos MD, and Jean David Zeitoun MD); the 'Co-founder' part of the claimed title is not clearly supported, though the medtech-executive background claim is.
**Stage / fundraise:** Series A (post-FDA-clearance commercial scale-up), Paris, founded 2022, ~10 employees. Three FDA 510(k) clearances + PCCP, fresh EU CE mark; now commercializing in US and expanding across Europe. / €2M seed from Sofinnova Partners (MD Start III), May 2023. €11M Series A announced 8 Jan 2026, co-led by Odyssée Venture and GO Capital, with Mussallem CHD Alliance, Lift Value, IDAHO HealthTech Club (Side Angels), founding investor Sofinnova Partners, and clinician/angel investors (Prof. Laurent Salomon, Sacha Loiseau, John Gridley). Use of funds: US commercialization, European expansion, and product innovation.
**Regulatory trigger:** SaMD (AI software for fetal-heart ultrasound). US: three FDA 510(k) clearances (B-Right Screen for CHD detection, Nov 2024; tablet/cart-side support, May 2025; B-Right Views for standard-view documentation + PCCP, May 2025) — 510(k) implies moderate-risk Class II in the US. EU: CE mark for the B-Right AI Platform secured (announced ~25 Jun 2026). As prenatal-screening diagnostic-aid SaMD under EU MDR, it falls in the higher software classes (Rule 11 → typically Class IIa/IIb), requiring IEC 62304 software lifecycle + full MDR technical documentation. Heavy, ongoing regulatory/QARA burden — they have a dedicated Director of QARA (Saramony Lebasnier). Reimbursement status not yet established.
**Email:** cecile.dupont@brightheart.ai (confidence low) — No personal address for the CEO is published. Confirmed company addresses exist (press@brightheart.fr and support@brightheart.ai), establishing two live BrightHeart domains, but the per-person local-part pattern (first.last vs firstlast vs finitial) is NOT confirmed — RocketReach's format page was inaccessible (HTTP 403). The guess cecile.dupont@brightheart.ai is an unverified first.last inference and must not be treated as a published address; LinkedIn DM via her profile is the safer first-touch channel.
**LinkedIn:** https://www.linkedin.com/in/ceciledupontredon/ **Website:** https://www.brightheart.ai
**Score:** 12 -> Tier A
**Hook:** Congrats on the €11M Series A and the new CE mark — going from FDA-cleared in the US to scaling across Europe means shipping B-Right releases fast while keeping the IEC 62304 / MDR file airtight on a ~10-person team. You're already hiring devs; OmDev gives a fellow medtech-operator-led team a senior squad + a dedicated CTO at a fixed monthly price ~3x cheaper than building that team in Paris, and our pipeline emits compliance evidence by default (SOUP register signed every build + requirements→code→test traceability feeding your 62304/MDR file) so QARA's audit prep shrinks instead of growing with each market. You own the code; we don't certify — we hand Saramony's team clean evidence.

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## Founder & background
Cécile Dupont Redon — CEO & co-founder (since Nov 2022) and Partner at Sofinnova Partners (MD Start medtech accelerator). She is a medtech executive / serial entrepreneur, not an engineer: ex-CEO HEPTA Medical, ex-COO Gradient Denervation Technologies, ex-Director Clinical/Regulatory/Market Access at SafeHeal (ran its first-in-human study + EU/US approvals); board member at Endoron Medical. Trained in biomedical engineering (UT Compiègne) + corporate finance at HEC Paris; named an In Vivo "Rising Leader." Clinical co-founders Dr. Marilyne Levy and Dr. Bertrand Stos (pediatric/fetal cardiologists). Sources: [Sofinnova bio](https://sofinnovapartners.com/team/cecile-dupont), [LinkedIn](https://www.linkedin.com/in/ceciledupontredon/), [In Vivo Rising Leader](https://sofinnovapartners.com/news/cecile-dupont-md-start-partner-selected-as-in-vivo-rising-leader).

## Funding & momentum
€2M seed from Sofinnova (MD Start III) in May 2023, then an **€11M Series A on 8 Jan 2026** co-led by Odyssée Venture and GO Capital (with Mussallem CHD Alliance, Lift Value, IDAHO HealthTech Club, Sofinnova, and clinician angels). Capital is earmarked for US commercialization, European expansion, and product innovation — a clear "ship faster across two markets" mandate. Sources: [Sofinnova seed](https://sofinnovapartners.com/news/brightheart-announces-eur2-million-in-seed-financing-from-sofinnova-partners-to-improve-the-detection-of-fetal-heart-abnormalities), [tech.eu Series A](https://tech.eu/2026/01/08/brightheart-bags-eur11m-to-expand-fda-cleared-ai-ultrasound-platform-across-the-us-and-europe/).

## Product & regulatory
B-Right AI Platform: real-time AI that standardizes prenatal ultrasound (B-Right Views) and detects congenital heart defects (B-Right Screen) — 98.7% sensitivity / 97.7% specificity over 877 exams. This is SaMD: three US FDA 510(k) clearances + a PCCP (Class II), and a freshly secured EU **CE mark** for the platform. Under EU MDR Rule 11, screening-diagnostic SaMD typically sits at **Class IIa/IIb**, mandating IEC 62304 software-lifecycle records and full MDR technical documentation maintained release-over-release. Reimbursement not yet established. Sources: [CE mark](https://www.medicaldevice-network.com/news/brightheart-b-right-ce-mark-ai-prenatal-ultrasound-platform/), [first FDA clearance](https://www.businesswire.com/news/home/20241115006631/en/BrightHeart-Secures-FDA-Clearance-for-First-AI-Software-Revolutionizing-Prenatal-Fetal-Heart-Ultrasound-Evaluations), [3rd FDA + PCCP](https://www.businesswire.com/news/home/20250514277209/en/BrightHeart-Obtains-Third-FDA-Clearance-and-PCCP-Approval-Becoming-First-to-Offer-One-Integrated-Solution-for-Real-Time-Fetal-Heart-Documentation-and-CHD-Detection).

## Pain & buying signals
**Actively hiring developers (GetYourJob signal)** at only ~10 staff. They run a regulated, multi-cleared SaMD that demands continuous IEC 62304 + MDR file upkeep on every release, while simultaneously commercializing in the US and expanding across Europe on €11M — heavy product velocity on a tiny team. Regulatory ownership is in-house (Director of QARA Saramony Lebasnier; CTO Christophe Gardella; Head of Software Olivier Tranzer), so the bottleneck is engineering throughput and the cost of senior Paris devs, not strategy.

**Why OmDev fits:** A founder who is a medtech operator (and a VC who knows burn math) will respond to: a senior dev squad + a dedicated CTO at a fixed monthly price ~3x cheaper than hiring that team in Paris, where you own the code. Critically, OmDev's pipeline emits the compliance evidence QARA needs by default — a SOUP register signed at every build plus requirements→code→test traceability that feeds the IEC 62304 / MDR file — so audit prep shrinks instead of growing with each new market. OmDev does not certify; it hands Saramony's team clean, ready evidence. References: CadSmile, SpeechLink.

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**Sources:** https://sofinnovapartners.com/news/brightheart-announces-eur2-million-in-seed-financing-from-sofinnova-partners-to-improve-the-detection-of-fetal-heart-abnormalities · https://tech.eu/2026/01/08/brightheart-bags-eur11m-to-expand-fda-cleared-ai-ultrasound-platform-across-the-us-and-europe/ · https://www.medicaldevice-network.com/news/brightheart-b-right-ce-mark-ai-prenatal-ultrasound-platform/ · https://www.businesswire.com/news/home/20241115006631/en/BrightHeart-Secures-FDA-Clearance-for-First-AI-Software-Revolutionizing-Prenatal-Fetal-Heart-Ultrasound-Evaluations · https://www.businesswire.com/news/home/20250514277209/en/BrightHeart-Obtains-Third-FDA-Clearance-and-PCCP-Approval-Becoming-First-to-Offer-One-Integrated-Solution-for-Real-Time-Fetal-Heart-Documentation-and-CHD-Detection · https://sofinnovapartners.com/team/cecile-dupont · https://www.linkedin.com/in/ceciledupontredon/ · https://sofinnovapartners.com/news/cecile-dupont-md-start-partner-selected-as-in-vivo-rising-leader · https://www.crunchbase.com/organization/brightheart-85ba