Regulatory

Siemens Healthineers Gains FDA Clearance for Magnetom Flow.Ace

The product is the company's first helium-free 1.5 Tesla MR scanner.

The Magnetom Flow.Ace. Photo: Siemens Healthineers.

The U.S. Food and Drug Administration has cleared Siemens Healthineers’ Magnetom Flow.Ace, its first 1.5 tesla (T) platform for magnetic resonance (MR) imaging with a closed helium circuit and no quench pipe.

With a 60 cm bore, the system is also the first Siemens Healthineers MR scanner to be marketed to the veterinary radiology community as well as for general radiology. It covers the entire range of MR applications, with image reconstruction based on artificial intelligence (AI) to enable shorter scan times with improved image quality. Its wide range of contour and dedicated MR coils can be used for a variety of human anatomies. The Magnetom Flow.Ace is the second virtually helium-free MR platform from Siemens Healthineers, following the 0.55T Magnetom Free platform.

“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 Magnetom Flow.Ace requires only 0.7 liters of liquid helium for cooling compared with conventional MRI scanners, which typically require more than 1,000 liters. This reduced helium requirement is due to the magnet’s DryCool1 technology, which can lower costs and save resources by dramatically reducing a dependency on helium refills. The system design also eliminates the need for a quench pipe, which was required previously to safely allow large amounts of gaseous helium to escape directly into the atmosphere during an emergency shutdown. This lack of a quench pipe, combined with the scanner’s compact size, can reduce installation requirements and costs compared with those of other 1.5T MR scanners.

In addition, the Magnetom Flow.Ace reduces annual energy consumption by more than 30% compared with the company’s previous generation of MR scanners.2 The Eco Power Mode feature automatically deactivates energy-intensive components when they are not needed.

 The scanner uses AI to support automated workflows as well as improved image quality and shorter exam times. Deep Resolve image reconstruction technology enables accelerated image acquisition, removes noise, and improves the sharpness of small structures.

Siemens Healthineers is a global provider of healthcare equipment, solutions and services, with activities in more than 180 countries and direct representation in more than 70. The group comprises Siemens Healthineers AG, listed as SHL in Frankfurt, Germany, and its subsidiaries. The company is principally active in the areas of imaging, diagnostics, cancer care and minimally invasive therapies, augmented by digital technology and artificial intelligence. In fiscal 2024 (ended Sept. 30, 2024) Siemens Healthineers had approximately 72,000 employees worldwide and generated around €22.4 billion in revenue.

References
1 The Magnetom Flow.Ace is equipped with Dry Cool technology, which requires only 0.7 liters of liquid helium for magnet cooling over the lifetime of the device.
2 Data on file.

Keep Up With Our Content. Subscribe To Medical Product Outsourcing Newsletters

Topics