Scarlet has raised $50M in series B funding to build what it calls an AI-native platform for medical device certification.
Headline led the round. The London company was founded by engineers who previously worked at Babylon Health, the once-high-flying digital care provider that collapsed in 2023.
The bottleneck
Getting an AI-powered medical device cleared is slow and paperwork-heavy. Manufacturers must assemble clinical evidence, risk documentation and quality records to satisfy regulators in each market.
Scarlet’s pitch is that much of that work can be generated, checked and tracked in software rather than assembled by hand. Faster certification means devices reach patients sooner – and vendors spend less getting there.
A crowded moment for medtech AI
The funding lands amid a wave of interest in AI that touches regulated devices. The FDA has signaled that retraining an algorithm or moving it to the cloud can require a fresh clearance, adding compliance weight on manufacturers.
Scarlet is not the only company chasing that pain. Several consultancies and software vendors already sell regulatory tooling, and regulators themselves are modernizing review processes.
The company says the capital will fund product development and expansion. Its bet is that certification – not the model itself – is where AI medtech often stalls.
