MyCardium’s quadruple regulatory cleared cardiac AI platform
MyCardium AI is a rapidly growing UK-based company delivering advanced core-lab services, now with two CE-marked and FDA-cleared AI medical devices - 1CMR Pro and EchoConfidence - built on decades of leading academic research. With Hardian Health as a strategic partner, MyCardium navigated complex regulatory pathways with exceptional speed and success. How did they do it?
Starting with regulatory and commercial strategy
MyCardium AI specialises in advanced cardiovascular imaging and precision measurement. Their products, 1CMR Pro and EchoConfidence, are AI-powered clinical tools designed to support cardiologists by improving the consistency and accuracy of cardiac MRI and echocardiography measurements.
From the outset, MyCardium AI intended to bring multiple products to market across several jurisdictions. This ambition required a regulatory and commercial strategy that looked far beyond the immediate horizon.
Together, we began by establishing foundational processes that would scale with the company’s pipeline. By designing quality and regulatory systems with future products and global submissions in mind, we avoided costly rework and prevented the need to revisit fundamental documentation as new devices progressed.
Equally important was understanding MyCardium AI’s internal capabilities. Early conversations helped us assess capacity, identify gaps, and determine where Hardian’s support would be most impactful. By aligning regulatory strategy with team structure, we ensured that workstreams remained efficient and that efforts across multiple products could be parallelised without overstretching resources.
Setting clear aims for clinical data
With the regulatory pathway defined, the next priority was determining the level and structure of evidence needed to satisfy both European and US regulators.
MyCardium AI’s academic foundation as a UCL spinout gave it a unique advantage. The company possessed rare datasets and early prototype evaluations demonstrating that its AI models were more precise than human experts in measuring cardiac MRI anatomy. We worked closely with the team to interpret this data and present it in a way that made the clinical relevance of improved precision unmistakable to regulators.
This was a significant claims strategy milestone. While most AI medical devices benchmark their accuracy against experts, very few can support claims of superior precision - largely because such claims require repeat imaging datasets that are exceptionally difficult to collect.
By substantiating precision-based claims, MyCardium AI could indirectly demonstrate important clinical benefits: more stable measurements support clinicians in tracking disease progression and making management decisions with greater confidence. We also ensured that validation methodologies were aligned to regulatory expectations across jurisdictions, strengthening both credibility and consistency.
Strategic use of FDA pre-submissions
With the evidence strategy defined, we guided MyCardium AI through a structured FDA pre-submission process. These touchpoints played a pivotal role in shaping the final submissions. By testing assumptions around validation and claims early, the team could adjust course before committing to full technical files.
Staggering pre-submissions across products enabled us to carry forward insights from one meeting to the next. This approach reduced friction, shortened timelines, and ensured that both submissions ultimately reflected the latest regulatory expectations and feedback.
Building internal regulatory and quality confidence
When Hardian first partnered with MyCardium AI, the team was small and relatively inexperienced in medical device regulation and quality management. Rather than create long-term dependence, our approach was to build capability from within. Together we:
Co-developed the Quality Management System (QMS) and modular technical documentation
Supported clinical and technical teams in understanding the regulatory rationale behind each requirement
Mentored the team on evidence generation, classification, claims development, and jurisdictional differences
Over time, MyCardium AI’s internal expertise grew significantly, enabling the company to take increasing ownership of regulatory activities and move faster with each subsequent milestone.
“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 Co-Founder: Chief Operating Officer, MyCardium AI
Lessons for the wider Industry
MyCardium AI’s success reflects a set of principles that are increasingly essential for AI-driven medical device companies:
Start early with strategy. Regulatory planning is not an operational afterthought; it is a core enabler of commercial success.
Commit to scientific rigour. What most fail to realise is that achieving regulatory clearance is as much about robust science, as it is about quality assurance. Strong claims require strong evidence. MyCardium AI’s willingness to fully invest in robust validation positioned it ahead of competitors.
Embed quality from day one. A culture that treats quality and compliance as integral components of innovation avoids the costly pitfalls that hinder many early-stage companies.
By embracing these principles - and by partnering with Hardian Health - MyCardium AI achieved what many in the sector struggle to accomplish: international clearances for multiple AI devices in a relatively short period.
If your company is navigating complex regulatory pathways for an AI medical device, Hardian Health can help. Get in touch to discover how our expertise can support your journey from concept to clearance.
