Imricor Medical Systems, Inc. has announced the commencement of its U.S. commercial launch for its NorthStar system, marking the transition from development to active sales. The company reported that Rady Children’s Hospital–San Diego became its first commercial U.S. hospital customer, establishing the country’s first commercial interventional MR cardiac catheterisation program. Just two weeks after the launch, Children’s Medical Center Dallas, the flagship hospital of Children’s Health, agreed to purchase NorthStar, becoming the company’s second U.S. customer. This sale is noted as the first commercial outcome of a compatibility declaration issued by Philips.
The company launched a new business vertical, Imricor Cardiovascular, to focus on real-time MR guidance for radiation-free cardiac catheterisation. This vertical targets a U.S. market comprising over 250 children’s hospitals and more than 2,000 adult hospitals. To assist with adoption, Imricor introduced Imricor Finance, a vendor financing program in partnership with DLL, allowing hospitals to acquire equipment over one to seven years while Imricor receives full payment upfront.
Regulatory progress included FDA 510(k) clearances for pediatric label expansions of NorthStar and the Vision-MR Diagnostic Catheter, allowing both products for use in patients of all ages. The company also submitted NavTrac and NavTrac-MR Steerable Introducers for FDA clearance, completing its 510(k) submissions. Additionally, the FDA accepted and closed the manufacturing module of the Vision-MR Ablation Catheter PMA application.
Financial results for the third quarter ended September 30, 2026, showed revenue of US$188,000, a 437% increase compared to the prior corresponding period. The company reported a net loss of US$2.9 million for the quarter. As of September 30, 2026, the company held cash and cash equivalents of US$62.1 million.
