GE HealthCare nabs 3 notable MRI FDA clearances
GE HealthCare has secured three notable new MRI clearances from the U.S. Food and Drug Administration.
On Thursday, the company announced the clearance of two MRI systems, Signa Sprint with Freelium and Signa Bolt, and one artificial intelligence-enabled workflow platform. Each of the three cleared produts were designed with the rising demand for MR imaging in mind, according to the company’s president and CEO of MR, Kelly Londy.
“Achieving FDA clearance of our next-generation Signa MRI technology underscores our commitment to expanding access to high-quality imaging and elevating the standard of care for patients everywhere,” Londy said in an announcement. “As MRI demand continues to rise across clinical areas, providers need solutions that deliver greater efficiency without compromising diagnostic precision."
More on the clearances:
The Signa Sprint with Freelium is a 1.5 sealed “helium-free” scanner that uses less than 1% of the amount of helium that standard magnets require to keep cool. The system provides acceptable image quality without the need for increased power consumption and comes equipped with AI-powered image reconstructions. What’s more, the ventless magnet’s compact size allows for more flexible infrastructure requirements, enabling it to be installed in more versatile locations.
The Signa Bolt is GE’s latest take on a 3T scanner. The Bolt’s design was built on a deep learning foundation with streamlined workflows in mind. GE maintains that the system offers research-level performance at approximately 30% lower power consumption compared to other 3T systems on the market. It also features the company’s new Air Coil suite, which was designed to enhance patient comfort and reduce the likelihood of needing additional imaging sequences or exams.
Both systems are powered with Signa One—artificial intelligence support that streamlines workflows and enhances user experience. The platform features multiple AI workflow solutions, including an intuitive user interface, an automated Signa One camera with in-room console live feed, landmark and positioning assistance and more.
Learn more about the new clearances here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.