Imricor Medical Systems Submits Mapping System to US FDA for Pediatric Label Expansion
MT Newswires Live
Apr 08
Imricor Medical Systems (ASX:IMR) submitted its NorthStar 3D mapping and guidance system to the US Food and Drug Administration (FDA) for pediatric label expansion through the Special 510(k) program, according to a Wednesday filing with the Australian bourse.
The expansion is intended to support the establishment of an installed base in pediatric centers in the US, the filing said.
NorthStar had received FDA clearance for the use of the system in adult patients, as disclosed in January, per the filing.
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