FDA Grants 510(k) Clearance to Sonic Incytes' Velacur® Determined Fat Fraction (VDFF), a breakthrough for patients with MASLD and MASH [Yahoo! Finance]
Madrigal Pharmaceuticals, Inc. (MDGL)
Last madrigal pharmaceuticals, inc. earnings: 2/26 06:50 am
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Source: Yahoo! Finance
Food and Drug Administration (FDA) has granted 510(k) clearance for its Velacur® Determined Fat Fraction (VDFF). This innovative measurement tool is integrated into the Velacur® device software, combining quantitative measures of ultrasound attenuation and backscatter. With a strong correlation coefficient of 0.85, VDFF estimates MRI proton density fat fraction (MRI-PDFF) , the hospital-based gold standard in liver fat measurement. VDFF has an outstanding accuracy (AUC) of 95% as a classifier of patients with more than 5% MRI-PDFF , a definition for the presence of hepatic steatosis. VDFF delivers similar clinical utility to MRI-PDFF at the point of care, transforming the management of hepatic steatosis. Metabolic dysfunction-associated steatotic liver disease (MASLD) affects almost 100 million people in the US alone, with an estimated 20% progressing to metabolic dysfunction associated steatohepatitis (MASH), an advanced chronic disease leading to cancer and death. MASH and MASLD
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News
- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) was upgraded by analysts at StockNews.com to a "sell" rating.MarketBeat
- FDA grants clearance to Sonic Incytes' VDFF for liver health assessment [Yahoo! Finance]Yahoo! Finance
- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) was upgraded by analysts at StockNews.com to a "sell" rating.MarketBeat
- Why Is Madrigal (MDGL) Up 1% Since Last Earnings Report? [Yahoo! Finance]Yahoo! Finance
- Madrigal Pharmaceuticals, Inc. to Participate in the Morgan Stanley 22nd Annual Global Healthcare ConferenceGlobeNewswire