# Scarlet Raises $50M for AI Medical Device Certification

> Scarlet secures $50M Series B to accelerate AI medical device approvals.
- Title: Scarlet Raises $50M for AI Medical Device Certification
- Summary: Scarlet secures $50M Series B to accelerate AI medical device approvals. Scarlet, an AI medical device certifier, raised $50 million to speed up regulatory…
- Keywords: scarlet, ai medical device certification, series b, medical devices, eu notified body, us food and drug administration, nhs england, flo health, startups, business, Raises, 50M
- Source: Dealroom — https://dealroom.co/news/161748-scarlet-raises-50m-to-speed-up-ai-medical-device-certification
- Published: 2026-10-12T14:24:19+00:00
- Read time: 1 min
- Topics: scarlet, ai medical device certification, series b, medical devices, eu notified body, us food and drug administration, nhs england, flo health, startups, business
## Funding Round
Scarlet raised $50 million in a Series B round led by Headline Capital.
## Certification Role
Scarlet decides whether ai medical devices can be sold in the EU, UK, and US.
## Speed Focus
Training takes weeks but assessment runs 12 to 18 months with updates adding six to eight months.
## Customer Impact
Scarlet's certification helps companies like Flo Health with 500 million downloads and NHS England.
## Key takeaway

Scarlet, an AI medical device certifier, raised $50 million to speed up regulatory approvals for AI health tech.