Artificial intelligence (AI) and software-based medical device-centric company, Scarlet, has banked $50m in a Series B round to expand the reach of its certification platform, which it claims will help bring AI-powered medtech innovation to market quicker.
With fresh capital in hand from lead investor Headline as well as additional contributors including, but not limited to Notion Capital, Atomico and Creandum, the London-based company plans to expand its presence in the US and Asia-Pacific (APAC) markets by bolstering its arsenal of AI reviewers and engineers. These staff members play a key role in assessing technical documentation uploaded by Scarlet’s users to decide if they meet the relevant regulations and should thus be released onto the market.
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Aside from beefing up its workforce, Scarlet also plans to expand its certification offerings in this space, though the company is yet to provide further details on exactly how this will transpire.
Scarlet designed its namesake software- and AI-focused technology to fill a niche that it claims no other government-designated certification body has filled, as the company says it is the only platform to specialise in the review of medtech software and AI.
Customers can use Scarlet by uploading their documentation in any format for review by qualified personnel. Thus far, the technology has secured designations from European, British and US regulators, where Scarlet is recognised as a Third-Party Review Organization.
On top of its role in certifying an AI-powered medical technology or software, Scarlet designed its platform to continuously monitor the way an AI product is built. Through a subscription model, customers can gain access to ongoing surveillance, annual audits and product changes to ensure a product’s certification remains valid as the platform changes and upgrades over time.
According to Scarlet, its customers are often companies building devices that use next-generation AI tools like large language models (LLMs) and computer vision models – including players like period tracker app creator Flo Health and radiology specialist DeepHealth.
Governance remains core to the AI conversation
With the use of AI continuously on the rise in the life sciences space, medtech companies implementing the technology must find ways to safely and effectively incorporate it into the workflow, as incidents like unexpected hacking ring alarm bells.
With this in mind, AI governance has become a core consideration for companies introducing or scaling their use of AI in the daily workflow, with experts noting that continuous monitoring of a model’s compliance and the introduction of stringent guardrails, as well as the restriction of an AI’s access to unnecessary data and human-led review of its utility, will facilitate the safe implementation of this technology.
According to a recent GlobalData report, the combined AI market – including across the healthcare, pharmaceutical and medical device sectors – is expected to reach a value of $57.4bn in 2029, marking a compound annual growth rate of about 37% from its $11.9bn value in 2024.
