Latest Electrophysiology News

Imricor Medical Systems has reached a crucial milestone as the FDA accepts and closes the manufacturing module of its Premarket Approval submission, advancing its MR-guided electrophysiology devices closer to US market entry.

Imricor Medical Systems and Philips have launched a combined interventional MR lab solution integrating Philips’ 1.5T BlueSeal MRI with Imricor’s MR-compatible systems, targeting cardiac electrophysiology and setting a new standard for MR-guided interventions.

Philips has officially declared compatibility for Imricor’s interventional MR devices with its magnetic resonance systems, enabling commercial clinical use and collaboration at a leading cardiology congress.

Imricor Medical Systems has officially launched its US commercial operations, securing Rady Children’s Hospital–San Diego as the first customer for its NorthStar iMR mapping system, following key FDA clearances including pediatric approvals.

EBR Systems has launched the WiSE Coupler in the US, a new accessory designed to improve the implantation of its wireless cardiac pacing electrode. The device has FDA clearance and was piloted in 10 procedures, marking another step in the company’s US commercial expansion.

Imricor Medical Systems has submitted its final 510(k) devices to the FDA, marking a major step towards commercialising its MRI-guided cardiac catheterisation platform in the US.

Imricor Medical Systems expands its US market reach with FDA 510(k) clearances for pediatric use of its NorthStar system and Vision-MR Diagnostic Catheter, enabling radiation-free cardiac catheterisations for children.

Imricor Medical Systems has submitted the third of four Premarket Approval modules to the FDA, marking a key step towards US approval of its MR-guided cardiac ablation devices.

Imricor Medical Systems has secured A$60 million through a placement to fund its US commercial rollout, regulatory approvals, and clinical programs, boosting its cash reserves to nearly A$103 million.

Imricor Medical Systems advanced FDA clearances and expanded clinical trials in Q1 CY26, positioning for commercial growth despite higher operating cash outflows.

Imricor Medical Systems has submitted its NorthStar Mapping System for FDA pediatric label expansion, aiming to accelerate adoption in over 250 US children’s hospitals and broaden its commercial footprint.

Imricor Medical Systems has taken a significant step toward US market entry by submitting its Advantage-MR EP Recorder/Stimulator system for FDA 510(k) clearance, aiming to enhance MRI-guided cardiac procedures.