Scarlet Raises $50M Series B for AI Medical Certification

The second release is where a medical software company's relationship with its certifier starts to become especially interesting. Scarlet is building that relationship into its business, with a $50M Series B to expand the experts and certification coverage supporting manufacturers as their AI devices evolve.

The London-based company announced the round on October 12, 2026. Headline led, Notion Capital joined as a new investor, and Atomico, Creandum, Kindred Capital and Entrepreneurs First returned. Cofounders James Dewar, CEO, and Jamie Cox, CTO, are using the financing to widen Scarlet's offerings and increase its presence in the US and Asia-Pacific.

For healthcare AI operators, this puts another institution inside the product plan. A manufacturer can keep improving its software while maintaining a continuing assessment relationship, with expert capacity and the evidence around each change becoming part of the commercial schedule.

A certification business built around software's working life

Scarlet's customers make software and AI medical devices. Its job is to assess the evidence those manufacturers submit against the requirements within its authorized scope, a role with consequences that continue after an initial certificate has been issued.

The company's public information policy describes eligibility and risk-classification checks, management-system audits, technical documentation reviews and surveillance. Those procedures give substance to the idea of an ongoing relationship: a device remains under an assessment cycle as the manufacturer continues operating it. The policy also provides for refusal, restriction, suspension and withdrawal of certification when warranted.

That makes the customer relationship unusually demanding. The same manufacturer paying for an assessment can receive a decision that prevents a planned release. Scarlet has to make the service useful enough for a company to keep working with it while preserving the independence that gives its decisions value.

Software adds another practical dimension. A product team can revise the implementation repeatedly, and each proposed change needs to be understood within the device's intended use and evidence. The certifier becomes part of how that team manages development, with a record that remains legible to the people responsible for reviewing it.

The founders chose to build the institution

James Dewar and Jamie Cox encountered certification delays while working on medical AI at Babylon Health. They subsequently built Scarlet around the work of assessing other manufacturers' devices, taking responsibility for a part of the healthcare market they had experienced from the developer's side.

Entrepreneurs First's company profile identifies Dewar as CEO and Cox as CTO. Dewar's background includes computer science and machine learning; Cox studied medicine before moving into software engineering. Their experience makes the choice of company particularly revealing: the engineering problem includes the institution that decides whether the engineering can enter a regulated market.

The same investor profile records an earlier £6M Seed round led by Creandum in August 2022 and a $17.5M Series A led by Atomico in June 2024. The new Series B adds $50M. An exact lifetime USD total would require a supported treatment of the sterling financing, so the individual rounds provide the cleaner account of Scarlet's funding history.

Capital here supports a business whose growth requires both technical systems and qualified people. Headline's investment account describes reviewers making regulatory judgments while technology handles documentation processing and organization. Findings are tied to supporting evidence and applicable requirements, giving the assessment a traceable record as it moves through review.

Regulatory authority has a geography and a scope

Scarlet operates within specific regulatory designations. The MHRA's January 2024 announcement established Scarlet NB UK as an Approved Body focused on software and AI medical devices, and the agency's current register continues to list the organization.

In the US, the FDA's recognized third-party review list includes Scarlet NB B.V. for eligible 510(k) submissions. That recognition is bounded by the program and the listed device codes. A manufacturer's route still depends on its device, the applicable requirements and the relevant jurisdiction.

For a company planning to sell across markets, those distinctions matter commercially. A launch plan has to account for which assessment applies, who can conduct it and what evidence the device requires. Expertise in one jurisdiction gives a manufacturer a useful starting relationship; expansion into another market brings additional work to organize.

Scarlet's competitive position consequently rests on more than the speed of its software. It needs authorized coverage, reviewers who understand the devices within that coverage, and decisions that remain defensible under scrutiny. Adding markets and certification offerings increases the number of relationships the company must maintain, including the relationship with the institutions overseeing its own work.

Expansion reaches the release calendar

Notion Capital's investment note describes plans to grow Scarlet's expert team and AI capabilities, expand its offerings and increase its US and Asia-Pacific footprint. The company's current careers page lists regulatory, engineering and commercial positions, including roles in London and New York, without publishing a numerical hiring target.

Scarlet reports that customers have reduced initial certification timelines by a year or more and shortened product-update cycles from months to weeks. These are company-reported outcomes. Its customer stories show specific applications across physiotherapy, radiology and dermatology, giving manufacturers examples to examine against their own products and assessment needs.

For an operator, the useful question is how that ongoing service fits the company's actual release process. Product development, regulatory evidence and commercial commitments each have people responsible for them. A clearer assessment relationship can give those teams a shared basis for planning, even while every certification decision depends on the device and the evidence supplied.

The $50M financing extends Scarlet's capacity to take on that work across more customers and markets. As the roster grows, James Dewar and Jamie Cox will have more manufacturers relying on an institution built by former developers, with the next software release already making new demands on the record supporting the current one.