The California start-up came to Europe with solid clinical data and an FDA authorization in hand for its AI cardiac ultrasound software platform, but it ran up against significant notified body delays, expertise gaps, and a Medical Device Regulation that hasn’t adopted a US FDA level of flexibility for AI/ML tech. We spoke to Caption Health’s regulatory chief Tahir Rizvi about the firm’s MDR experience.
AI medtech innovator Caption Health touted its first CE mark last month as a key milestone in support of global launch plans for the firm’s novel cardiac ultrasound software tool. But the EU certification, earned under the Medical Device Regulation (MDR), came in behind schedule as a result of notified body delays. Also, the CE mark lacks the flexibility of the US regulatory authorization system to streamline future algorithm enhancements via a “predetermined change control plan.”
The Brisbane, CA, start-up is now playing catch-up with its EU and global regulatory strategy compared with in the US. “The EU MDR is very expensive to go through. It's very difficult to budget for,” Tahir Rizvi, head of quality assurance/regulatory affairs at Caption Health, told Market Pathways. “And just given that the review timelines are so unpredictable at this time, it's very difficult to account for that.”