Imricor Medical Systems (ASX:IMR) has received CE Mark certification under the European Union’s Medical Device Regulation for its NorthStar Mapping System.
NorthStar is approved as a Class IIa medical device. The system comprises a computer workstation and a software application, making it Imricor’s first commercial software-centric product globally.
Imricor said this milestone significantly strengthens its position as the market leader in interventional cardiac MRI (iCMR) and broadens its offerings across Europe and the Middle East.
Imricor chair and CEO Steve Wedan said, “Achieving CE Mark approval for NorthStar under EU MDR represents a transformative step towards establishing a global platform for MRI-guided interventions. I often say that NorthStar’s purpose is to transform MR imaging from something analogous to taking a picture with a still camera into something analogous to shooting a live video. When you’re guiding a medical procedure with MRI, you need ‘live video’ capabilities.
“We expected NorthStar’s CE mark approval mid-year, and we were pleased to receive it earlier than anticipated. But this is more than just a regulatory win. It’s the launch of our software era, and as we grow and expand interventional MRI applications even beyond cardiac ablations, I envision NorthStar growing and expanding to become the central hub of every interventional MRI practice.”