Imricor Medical Systems (ASX:IMR) announced that the US Food and Drug Administration has granted 510(k) clearance for its Vision-MR Diagnostic Catheter, marking the company’s first FDA-approved device.
The catheter, designed for use under real-time magnetic resonance imaging guidance, is a key component of Imricor's MRI-compatible electrophysiology platform.
FDA clearance allows the company to commercially market the device in the United States, the world’s largest EP market. Imricor anticipates additional regulatory approvals this year as it rolls out its full MRI-guided EP platform.
Steve Wedan, Chair and CEO of Imricor, described the milestone as "an extraordinarily big deal" for the company and praised the team’s efforts in bringing the first US device to market.
At the time of reporting, Imricor Medical Systems' share price was $1.85.