MyCardium AI
MyCardium AI is a UK-based cardiovascular imaging company developing regulated AI tools for cardiac MRI and echocardiography. Built on decades of academic research as a UCL spinout, its software improves the consistency and precision of cardiac measurements.
We supported MyCardium AI in securing CE marking and FDA clearance for their two AI medical devices, 1CMR Pro and EchoConfidence.
Class IIb (EU MDR), FDA product code (QIH LLZ and QIH).
What they needed
They needed a regulatory and commercial strategy that could support multiple AI medical devices progressing in parallel across Europe and the US. This included defining scalable quality systems, structuring a strong clinical evidence strategy, managing FDA engagement, and building internal regulatory capability without slowing product development or overstretching a small team.
Who are they?
Antony Shimmin, Director and CoFounder,
Chief Operating Officer, MyCardium AI:
“It was hard to distinguish the Hardian team from individual employees of the business as it didn't feel like they were a separate entity. The Hardian team felt fully invested and involved in our company from the beginning.”
“It was hard to distinguish the Hardian team from individual employees of the business as it didn't feel like they were a separate entity. The Hardian team felt fully invested and involved in our company from the beginning.”
Antony Shimmin,
Director and CoFounder, Chief Operating Officer, MyCardium AI
How we helped
We worked with the team to design future-proof regulatory and quality systems aligned to a growing pipeline. We shaped a precision-led clinical evidence strategy, guided staggered FDA pre-submissions to de-risk claims early, and co-developed the QMS and technical documentation while mentoring the team to build lasting in-house regulatory confidence.
The result
Alongside the quadruple regulatory approvals, the company established a scalable quality and regulatory foundation and developed strong internal expertise, enabling faster progress on future products and greater ownership of regulatory activities as the business continues to grow.