Imricor Medical Systems (ASX:IMR) — Material Events

ASX:IMR · 25 articles in the last 12 months · 100% assessed

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Major 3 articles Significant 19 articles Notable 3 articles Not Assessed 0 articles
Major ≥90 Significant 75–89 Notable 50–74 Routine <50 Not assessed
Significant Score 75–89
19
Imricor Advances MRI-Guided Cardiac Tech with FDA Submission of Advantage-MRMedium
Imricor submits Advantage-MR system for FDA 510(k) clearance, advancing MRI-guided cardiac procedures
6 Feb 2026 ·Regulatory Submission ·85
Imricor and Philips Unveil Commercial iMR Lab Solution for Cardiac InterventionsMedium
Imricor and Philips launch commercial interventional MR lab solution for cardiac care
28 Aug 2026 ·Product Launch ·85
Imricor Builds Regulatory and Clinical Momentum with US$7.8M Q1 OutflowMedium
Imricor advances FDA approvals, clinical trials, and commercial momentum with US$7.8M Q1 cash outflow
28 Apr 2026 ·Quarterly Activities Report and Appendix 4C ·85
Imricor Advances FDA Approval with Major Human Factors Study CompletionMedium
Imricor Completes Key Human Factors Study, Advances FDA Approval Pathway
18 Sept 2025 ·Regulatory Update ·85
Imricor Files SEC Form 10, Paving Way for U.S. Market ExpansionHigh
Imricor files SEC Form 10, advancing U.S. reporting status amid early commercial stage and FDA clearances
19 Mar 2026 ·Form 10 Registration Statement ·85
Imricor Medical Systems Reports 69.5% Revenue Drop Amid Strategic FDA PushHigh
Imricor Medical Systems reports 69.5% revenue drop, $25.3M net loss, FDA clearance achieved post-year-end
25 Feb 2026 ·Appendix 4E - Preliminary Final Report ·Unexpected ·85
Imricor Accelerates US Launch with Two Leading Pediatric Hospitals Securing NorthStarMedium
Children’s Medical Center Dallas becomes Imricor’s second U.S. customer, accelerating commercial momentum
10 Aug 2026 ·Customer Acquisition Announcement ·85
Imricor Advances FDA Filings and Expands European Market Amid Q3 Cash OutflowsMedium
Imricor advances FDA submissions, launches NorthStar in Europe, reports Q3 cash outflows of US$4.8M
22 Oct 2025 ·Quarterly Activities Report and Appendix 4C ·85
Imricor Raises A$60 Million to Accelerate US Launch and Clinical TrialsMedium
Imricor raises A$60 million to fund U.S. expansion and clinical programs
4 May 2026 ·Capital Raising ·85
Imricor Secures FDA Pediatric Clearances for NorthStar and Vision-MR CatheterMedium
Imricor obtains FDA clearance for pediatric use of NorthStar system and Vision-MR Diagnostic Catheter
2 July 2026 ·Regulatory Clearance ·85
Imricor Achieves World-First MRI-Guided Pulsed Field Ablation MilestoneMedium
Imricor completes world’s first MRI-guided Pulsed Field Ablation procedure
20 Oct 2025 ·ASX Announcement ·85
Imricor Secures FDA Nod for Groundbreaking NorthStar MRI Cardiac SystemHigh
Imricor gains FDA clearance for NorthStar MRI-native 3D cardiac mapping system
29 Jan 2026 ·Regulatory Approval Announcement ·85
Imricor Nears Full FDA Clearance with NavTrac Device SubmissionMedium
Imricor submits final 510(k) devices for FDA clearance, nearing full U.S. market platform
20 July 2026 ·Regulatory Submission Update ·80
Charité Hospital Joins Imricor’s VISABL-VT Trial, Advancing MRI-Guided Cardiac CareMedium
Charité Hospital joins Imricor's VISABL-VT trial as second global site
19 Dec 2025 ·Clinical Trial Update ·80
Imricor Breaks New Ground with MRI-Guided Cardiac Ablation MilestonesMedium
Imricor achieves world-first MRI-guided cardiac ablation milestones and advances clinical trials with US$5.2M Q4 cash outflow
28 Jan 2026 ·Quarterly Activities Report and Appendix 4C ·80
Imricor Advances US Market Bid with Form 10 Amendment and FDA ClearancesMedium
Imricor files Form 10 amendment; advances MRI-guided cardiac ablation commercialization with FDA clearances and ongoing clinical trials; reports 2025 net loss of $25.3M on early-stage revenues.
27 Apr 2026 ·Form 10 Amendment ·80
Imricor Seeks FDA Pediatric Approval to Expand NorthStar Market in USMedium
Imricor submits NorthStar for FDA pediatric label expansion to boost U.S. commercialization
8 Apr 2026 ·Regulatory Submission ·80
Oklahoma Heart Institute Boosts Imricor’s VISABL-AFL Trial MomentumMedium
Oklahoma Heart Institute joins Imricor's VISABL-AFL trial as fourth U.S. site, accelerating FDA approval process
3 Feb 2026 ·Clinical Trial Site Announcement ·75
Imricor Advances FDA Approval with Third PMA Module SubmissionMedium
Imricor submits third FDA PMA module for MR cardiac ablation devices
11 June 2026 ·Regulatory Submission ·75
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