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# FDA Clears Sonic Incytes’ Velacur Device
- URL: https://www.fdaweb.com/fda-clears-sonic-incytes-velacur-device/
- Published: 2024-09-10T12:00:00.000Z
- Updated: 2026-09-14T14:40:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157745

FDA has granted 510(k) clearance to Sonic Incytes Medical Corp’s Velacur Determined Fat Fraction, a measuring tool the company says is integrated into the Velacur device software combining quantitative measures of ultrasound attenuation and backscatter. A company [statement](https://www.businesswire.com/news/home/20240910410138/en/FDA-Grants-510-k-Clearance-to-Sonic-Incytes-Velacur%C2%AE-Determined-Fat-Fraction-VDFF-a-breakthrough-for-patients-with-MASLD-and-MASH?ref=fdaweb.com) says device results correlate well with the MRI proton density fat fraction, the hospital-based gold standard in liver fat measurement.

The company says the clearance is a breakthrough in point-of-care measurements for patients with metabolic dysfunction-associated steatolic liver disease and metabolic dysfunction-associated steatohepatitis.