Imricor Receives FDA Pediatric Clearances for iMR Device

• Imricor received FDA 510(k) clearance for NorthStar's pediatric use
• FDA cleared Vision-MR Diagnostic Catheter for pediatric use
• Clearances target pediatric patients sensitive to radiation exposure
• Pediatric market seen as an early commercial channel
• CEO highlights the importance of radiation-free procedures for children

Imricor Medical Systems, Inc. (ASX: IMR) announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its NorthStar system and Vision-MR Diagnostic Catheter for pediatric label expansion. This clearance allows Imricor to market these devices for use with patients of any age, including children. The pediatric market represents an attractive early commercial channel for Imricor's products, particularly for children's hospitals interested in reducing radiation exposure and the use of contrast dyes. Imricor's Chair and CEO, Steve Wedan, emphasized the company's commitment to providing technology that benefits all patient segments, particularly infants and young children.