FDA Approves Diffusion-Weighted Images for Elekta Unity, Expanding Options for Assessment During Therapy
ELEKTA B SHS UNSP/ADR (EKTAY)
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Source: PR Newswire
STOCKHOLM, Dec. 16, 2019 /PRNewswire/ -- Elekta (EKTA-B.ST) today announced that it has received 510(k) premarket notification from the U.S. Food and Drug Administration for the use of diffusion-weighted MR images (DWI) obtained with Elekta Unity to be interpreted by a trained physician. This expands the clinical utility of Elekta Unity to include biologic assessment of tumor response during therapy, allowing treatment adaptation based not just on gross anatomic changes but also on early biologic changes at the cellular level. Elekta Unity, the world's first high-field MR-Linac, received initial 510(k) clearance in December 2018 and CE mark in June 2018.DWI creates a map of the diffusion of water molecules at the cellular level and can be processed to generate the apparent diffusion coefficient, or ADC. A growing body of evidence shows that ADC changes within a tumor can provide important insights into an individual's tumor response that would previously have been unavailable during
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