Feebris × Scarlet
Achieving MDR certification of an AI Photoplethysmography (PPG) device in time to support critical NHS priorities
“We were facing a long and uncertain wait to get a truly ground-breaking device to market. Scarlet’s focus as a Notified Body on AI & SaMD meant we could release it in time and start changing lives for the better.”
Licy Prasad
Senior QARA Manager, Feebris
The Challenge
Feebris were facing a long, uncertain wait to get their pioneering AI medical device to market, delaying patient access and prohibiting health systems from adopting transformative technology that can alleviate capacity pressures
Customer Snapshot
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High-growth, start-up SaMD manufacturer developing AI-powered solutions for precision healthcare at home
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Helps provide a safe and effective alternative to hospital admission
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Seeking EU MDR certification for Class IIb AI medical device that ensures clinical reliability of cardiorespiratory information captured at home, with 98% accuracy across studies
The Scarlet Process
Scarlet combines clinical & AI experts and SaMD-friendly technical-file submission, which led to a highly efficient time to market for Feebris
Scarlet’s approach resulted in:
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EU MDR certification for an AI medical device
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The release of PlethAI to market in time to tackle critical NHS priorities such as winter pressures and the elective backlog
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Allowing NHS patients to be at home with their families rather than taking up a hospital bed
“Our certification journey with Scarlet was streamlined and efficient. They are really responsive, and the fact they’re AI specialised made for such a smooth and effective assessment process. That drastically increased the impact we were able to have with PlethAI.”
Licy Prasad
Senior QARA Manager, Feebris