# Scarlet

> AI-native certification body for software and AI medical devices.

## Why it is interesting

Scarlet is building regulatory infrastructure for continuously changing medical software—a bottleneck that grows as AI models iterate faster than conventional device certification workflows.

## Profile

- **Latest funding:** Series B — $50M (October 12, 2026)
- **Latest known valuation:** Not publicly disclosed
- **Total disclosed equity funding:** $68M
- **Stage:** series-b
- **Status:** private
- **Industries:** ai-ml, healthtech, enterprise-saas
- **Coverage:** full
- **Last updated:** 2026-10-12
- **Latest funding investors:** Headline, Notion Capital, Atomico, Creandum, Kindred Capital, Entrepreneurs First

## Key facts

- UK Approved Body for medical devices, listed by the MHRA as body 8536.
- EU notified body for medical devices, listed as Scarlet NB B.V. body 3022.
- FDA-recognized third-party review organization for eligible 510(k) submissions.

## Funding history

- Series B · $50M · October 12, 2026
  Source: https://www.notioncapital.com/resources/why-we-invested-in-scarlet
- Series A · $17.5M · June 2024
  Source: https://www.joinef.com/companies/scarlet/
- Seed · £6M · August 2022
  Source: https://www.joinef.com/companies/scarlet/

## Investors in our directory

- https://venturecapitaltracker.com/fund/headline
- https://venturecapitaltracker.com/fund/notion-capital
- https://venturecapitaltracker.com/fund/atomico
- https://venturecapitaltracker.com/fund/creandum
- https://venturecapitaltracker.com/fund/kindred-capital
- https://venturecapitaltracker.com/fund/entrepreneurs-first

## Related articles

- https://venturecapitaltracker.com/scarlet-50m-series-b-ai-medical-device-certification

**By:** [Venture Capital Tracker](https://venturecapitaltracker.com/editorial-policy)
**Last updated:** October 12, 2026

**Editorial note:** AI tools assisted with research, structure, or drafting. Venture Capital Tracker retains human editorial responsibility for factual accuracy, relevance, and source quality before publication.

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Source: https://venturecapitaltracker.com/startup/scarlet-ai-medical-device-certification