Siemens Gains FDA Clearance for Helium-Free 1.5T MRI Scanner With AI and Eco-Friendly Design

The U.S. Food and Drug Administration has officially cleared Siemens Healthineers’ newest helium-free MRI system, the Magnetom Flow.Ace, a 1.5 tesla scanner equipped with AI-driven workflows and designed to reduce both scan time and environmental impact.

Announced Thursday, the clearance makes Flow.Ace Siemens’ second helium-free scanner approved for the U.S. market, following the 2021 introduction of its 0.55T Magnetom Free system. It also becomes the company’s first MRI model approved for use in veterinary practices, expanding its clinical reach.

“With the FDA clearance of the Magnetom Flow.Ace, Siemens Healthineers is pleased to introduce our first helium-free 1.5T MR scanner,” said Katie Grant, head of magnetic resonance at Siemens Healthineers North America. “This 60 cm bore system is also available for veterinarians, with the same intelligent, high-end technology that we’ve offered to the general imaging community, at a highly attractive total cost of ownership.”

The scanner uses Deep Resolve, an advanced image reconstruction technology that speeds up acquisition, sharpens small structures, and minimizes image noise. These capabilities, combined with built-in AI features, help reduce scan times while maintaining diagnostic quality.

Unlike traditional MRI systems that rely heavily on helium, the Flow.Ace uses a sealed cooling system with DryCool technology and requires only 0.7 liters of liquid helium—far less than the 1,500 liters typically needed by standard scanners. The system also eliminates the need for a quench pipe, further simplifying installation and reducing infrastructure costs.

Its compact footprint and energy-efficient design result in more than 30% lower energy consumption compared to conventional MRI systems. This not only lowers operating expenses but contributes to conservation efforts for helium—a nonrenewable and increasingly scarce resource.

The FDA’s clearance arrives amid growing global concern over helium supply stability. The pandemic, geopolitical tensions, and disruptions in key producing regions have added urgency to the medical imaging industry's shift away from helium dependence, a transition that Siemens and other vendors have been preparing for over the past decade.