Last Updated: 12 October 2026
Scarlet, a London-based startup founded by James Dewar and Jamie Cox, is developing a certification system to help companies bring AI-powered medical devices to market faster. Its work focuses on how medical technology is assessed for safety and compliance before it can reach patients, particularly when software needs regular updates.
The number of AI medical devices receiving regulatory clearance continues to grow. According to the US Food and Drug Administration (FDA), more than 1,600 AI-enabled medical devices had been authorized for marketing in the United States as of September 2026. These include software used in medical imaging, disease detection, and treatment support, all of which must meet regulatory requirements before being used in healthcare.
Scarlet has raised $50 million in Series B funding, led by Headline, with participation from existing investors Kindred Capital, Creandum, Atomico, and Entrepreneurs First (EF). Notion Capital also joined the round as a new investor.
Before a medical device can be sold in a regulated market, its manufacturer must demonstrate that it meets the required safety, performance, and quality standards. This process involves submitting technical documents and evidence for review. The requirements also apply to medical software, including AI systems that analyze scans, help identify diseases, or support doctors in making clinical decisions.
Software developers face additional requirements when they update an existing product. Changes to an AI model may improve its accuracy, introduce new functions, or address technical problems. Depending on the changes involved, a manufacturer may need another regulatory assessment before releasing the updated version. That can extend the time between developing an improvement and making it available to patients.
Scarlet's customers have reduced certification timelines for new AI-enabled devices by a year or more, while shortening product update cycles from months to weeks, based on results reported by the company. Its system also records the evidence and regulatory requirements behind each assessment, allowing manufacturers and regulators to review how decisions were reached. These processes are described in Headline's investment announcement.
The new funding will help Scarlet expand the types of AI medical technology it can certify. Healthcare companies are developing software for different clinical purposes, and Scarlet plans to extend its certification services to cover more of these applications. This includes supporting manufacturers as they prepare their products for regulatory assessment.
The company also plans to expand in the United States and the Asia-Pacific region. A larger international presence would allow Scarlet to work with more medical device manufacturers operating in those markets. The expansion forms part of its plan to build a certification organization that can serve companies across multiple regulatory systems.
Hiring is another priority for the funding. Scarlet intends to increase its team of technical and regulatory specialists, who examine medical devices and assess whether they meet the relevant standards. These reviewers remain responsible for certification decisions, while the company's software handles much of the documentation processing and organization. More staff will allow Scarlet to manage a larger number of assessments.
Scarlet was founded in London in 2021 by James Dewar and Jamie Cox, who previously worked on software medical devices at Babylon Health. During their time there, they experienced delays in getting medical technology assessed. Those difficulties led them to establish a company focused on making certification processes more efficient for software and AI developers.
The company operates as a government-designated certification body. This means it has the legal authority to assess certain regulated products and issue the certifications manufacturers need to enter specific markets. Scarlet is a European Union Notified Body specializing in software and AI, holds regulatory authority in the United Kingdom, and is recognized by the US FDA as a third-party review organization.
Manufacturers using Scarlet can upload their technical documents in different formats. The platform processes and organizes these files, then provides feedback on whether the submission contains the necessary information. Qualified reviewers examine the evidence and make regulatory decisions. Each finding is linked to supporting documents and specific requirements, so manufacturers can understand what needs attention and regulators can review the reasoning behind an assessment.
The platform also handles certification work related to updates of existing medical devices. Its customers include companies developing AI-powered diagnostic tools and other medical software. For these manufacturers, ongoing assessments are part of maintaining compliance as their products change.
“Headline understands how innovation and regulation should go hand-in-hand, and how our approach enables the most ambitious technology companies in the world to get their AI products to patients at scale. We’re very excited to have Nancy and the Headline team as partners as we build out our global presence.”
— James Dewar, Co-founder of Scarlet
Headline, a venture capital firm that invests in technology companies, led the $50 million round. Notion Capital participated as a new investor, joining existing backers Kindred Capital, Creandum, Atomico, and Entrepreneurs First.
Scarlet previously raised £6 million in seed funding in 2022, followed by a $17.5 million Series A led by Atomico in June 2024. The latest round brings the company's total disclosed funding to more than $75 million.
With the new capital, Scarlet plans to hire more regulatory experts, expand its certification services, and increase its operations in the United States and Asia-Pacific. These investments will support its work with medical technology manufacturers seeking approval for new devices and updates to existing products.
