510(K) Submissions All In

Imricor announced the submission of its NavTrac and NavTrac-MR Steerable Introducers for market clearance under the FDA premarket notification pathway.

• All 510(k) submissions in: after today's submission all 11 of the company's US 510(k) applications have been submitted, with 6 of the 11 already approved.
• Approvals on track: Imricor has already received full approval under EU's Medical Device Regulation (MDR) which is generally considered stricter than the US FDA. Most recently Imricor has received FDA clearances for NorthStar and Vision-MR Diagnostic Catheter cleared for use in adult patients in January 2026 and for use in pediatric patients earlier this month. The last submission outstanding for Imricor for FDA approval is PMA Module 4. We expect this to be submitted sometime this quarter.
• Commercial traction: Beyond approvals evidence of commercial traction is key. Imricor has stated they are already well advanced in their sales process with several U.S. pediatric sites. This comes only weeks after receiving FDA approval (more details in our report: FDA clearance for Paediatric Use: Upside to our base Case Scenario).

Valuation and recommendation: Today's announcement continues the positive regulatory momentum for Imricor. Beyond further commercial validation other catalysts to lookout for include European pipeline conversion/revenue inflection (2H CY26 onwards); additional FDA clearances and PMA module progress (CY26), and Middle East expansion (2H CY26–1H CY27).

Fig 1: Imiricor Regulatory Approval Status

Source: Imricor