MyCardium AI Secures ISO 13485 Accreditation: Setting New Standards in Medical Device Quality

We are proud to announce that MyCardium AI has officially received ISO 13485 accreditation, a prestigious certification that reflects our commitment to providing safe, effective, and high-quality AI-driven medical solutions. This certification marks a pivotal step in our journey toward reshaping the future of cardiovascular diagnostics, solidifying our place as a leader in the development of AI technologies for the healthcare industry.

For MyCardium AI, this certification confirms that our processes for designing, developing, and delivering our flagship solutions—Echo AI and 1CMR—are in strict compliance with international regulatory standards. It assures clinicians, healthcare providers, and patients alike that our technology consistently meets the highest benchmarks of performance and reliability.

“Our achievement of ISO 13485 certification is a true testament to the dedication and hard work of every member of the MyCardium team,” said Michael Walker, Head of Compliance at MyCardium. “Navigating the complexities of implementing a rigorous Quality Management System has been challenging, especially for a new company. However, our staff and consultants, with the invaluable support of Hardian Health, have tirelessly devised, developed, and tested our Cardiac MRI and Echocardiogram Image Analysis products in accordance with the standard. This certificate reflects their unwavering commitment to quality and precision.”

This achievement demonstrates our unwavering focus on the following key areas:

Safety and Reliability: Our AI technologies, particularly Echo AI and 1CMR, have been developed with a strong focus on patient safety. ISO 13485 ensures that we consistently uphold the highest safety measures in all stages of product development and deployment.

Regulatory Compliance: The certification signifies that we are compliant with the regulations governing medical devices, both in Europe and globally. This is crucial as we continue to expand into new markets, ensuring our products are accessible to healthcare professionals worldwide.

Innovation with Accountability: As pioneers in cardiovascular AI technology, we are committed to continuous improvement. ISO 13485 ensures that innovation goes hand in hand with accountability, meaning every new advancement we make is rigorously tested and meets international standards.

The ISO 13485 certification strengthens the trust that clinicians and healthcare institutions place in MyCardium AI. Our solutions, Echo AI for echocardiography and 1CMR for cardiac MRI, are designed to support clinicians in making accurate, data- driven decisions. With the added assurance of ISO 13485 compliance, healthcare providers can rely on our software to enhance diagnostic precision, streamline workflows, and ultimately improve patient outcomes.

By offering AI solutions that have been accredited to the highest quality standards, we ensure that patients benefit from quicker and more accurate diagnoses, leading to better care and treatment plans.

A Collective Achievement

Achieving ISO 13485 accreditation was a collaborative effort, and we owe this success to the tireless dedication of the entire MyCardium AI team. Every department, from R&D to quality assurance, played a critical role in meeting the rigorous requirements of this certification. We are incredibly proud of our team’s commitment to excellence, innovation, and patient care.

We would also like to extend our deepest thanks to our partners, customers, and supporters. Your trust and collaboration have been instrumental in helping us achieve this important milestone. We look forward to continuing our partnerships as we advance our mission of transforming cardiovascular care through AI.

Looking Ahead: The Future of Cardiovascular AI

ISO 13485 accreditation is just the beginning of a new chapter for MyCardium AI. As we continue to grow, we are excited to push the boundaries of AI-driven healthcare solutions. Our focus remains on improving the accuracy, accessibility, and efficiency of cardiovascular diagnostics, empowering clinicians worldwide with tools that enhance patient care.

MyCardium’s Chief Executive, James Moon expressed equal enthusiasm about the certification, stating, “This milestone not only marks a significant step in our company’s growth but also establishes MyCardium as a professional manufacturer of medical device software. Our innovative products, 1CMR Pro and EchoConfidence are set to revolutionise cardiology practices and enhance patient outcomes globally. With our ISO 13485-compliant development process, we have submitted these products for regulatory approval in Europe and the United States, paving the way for clinical professionals to incorporate them into their everyday practices.”

In the coming months, we will be exploring new markets and expanding the reach of Echo AI and 1CMR. Our commitment to innovation and excellence is stronger than ever, and we are eager to share new developments with our partners and customers as we continue to lead the way in cardiovascular AI.