MRI‑compatible medical devices see FDA clearances and market growth in the US

iRadimed reported record full‑year 2025 revenue of $22.0 million and GAAP earnings per share of $1.75, fueled by its focus on MRI‑compatible infusion pumps and patient monitoring systems. The company received FDA 510(k) clearance for its MRidium 3870 MRI IV infusion pump and raised its quarterly cash dividend, while projecting 2026 revenue of $91‑96 million.

Imricor Medical Systems launched its US commercial operations by deploying the NorthStar interventional magnetic resonance cardiac mapping system at Rady Children’s Hospital in San Diego. The FDA granted safety clearance for NorthStar and the Vision‑MR diagnostic catheter, extending pediatric labeling to allow use in patients of any age and opening a market of over 250 children’s hospitals and 2,000 adult hospitals across the United States. Rady will become the first US hospital to perform radiation‑free cardiac catheterisation procedures guided by MRI, with plans to expand to electrophysiology and ablation.

Both companies are positioning MRI‑compatible technology as a radiation‑free alternative that enhances procedural safety and imaging quality, supported by recent regulatory approvals and expanding commercial deployments in the United States.