Lucida Medical × Scarlet
7 weeks to transfer an AI radiology device to Scarlet and begin shipping model updates immediately
“We transferred to Scarlet because our mission is to detect cancer as early as possible — we need to be able to update our devices regularly and without friction.”
Stefani Aleksandrova
Head of Regulatory Affairs, Lucida Medical
The Challenge
Lucida Medical needed a Notified Body with SaMD expertise that would enable them to consistently get the latest and best version of their ground-breaking AI system Prostate Intelligence (Pi) into the hands of users and to the patients who need it
Customer Snapshot
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Successful UK radiology start-up with product validated in a large clinical study in the UK NHS, PAIR-1
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Developed a transformational prostate-cancer-detection system widely deployed in the NHS that detects 95 out of 100 cases of clinically significant prostate cancer, with results confirmed by biopsy
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Wanted to perform rapid product iteration by choosing a Notified Body that understands AI and the critical importance of iterative development
The Scarlet Process
Scarlet's AI expertise and operational excellence got Lucida back to iterative product development with the transfer completed in 7 weeks, enabling Lucida to ship an updated model release days later
Scarlet’s approach resulted in:
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Dual EU MDR & ISO 13485 certificate transfer completed in weeks
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Shipping an update to Prostate Intelligence (Pi) within days of the transfer completing
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Lucida Medical’s newest and best version of Pi getting to healthcare institutions and patients across the NHS
“The transfer to Scarlet was seamless. We received regular updates throughout, the process was clear, and we always knew what was going on. We had no idea a transfer could be so swift.“
Stefani Aleksandrova
Head of Regulatory Affairs, Lucida Medical
