Corify Care announced today that it received CE mark approval under the new medical device regulation (MDR) for its Acorys cardiac mapping system.
The Spain-based startup designed Corify, a non-invasive mapping technology, to visualize the heart’s electrical activity. It creates visualizations in less than 10 minutes, eliminating the need for CT or MRI scans.
By utilizing body surface potential and a 3D torso model, the technology generates highly detailed electroanatomical maps of the heart. It allows clinicians to observe the heart’s electrical activity in real-time. This enhances their ability to diagnose and treat cardiac arrhythmias with precision, speed and safety.
Corify said in a news release that its technology addresses the issues of mapping cardiac arrhythmias like AFib. It enhances current options that can prove invasive, time-consuming and uncomfortable. Real-time heart maps facilitate quick and accurate decision-making, while Acorys’ non-invasive nature helps in cases when invasive procedures aren’t an option.
The company says CE mark enables it to expand its market presence across Europe as it aims to integrate Acorys worldwide. Next steps include obtaining FDA approval and expanding to the U.S. and elsewhere. Corify also plans to develop Acorys 2.0, which incorporates digital twins and new clinical applications.
“Achieving the CE Mark is a significant milestone for Corify Care,” said Andreu Climent, co-founder and CEO of Corify Care. “It validates our commitment to providing innovative, non-invasive solutions for cardiac arrhythmias. We are excited to bring the Acorys mapping system to hospitals across Europe and improve patient outcomes.”
