Sonic Incytes Medical Corp., a company focused on point-of-care (POC) ultrasound, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Velacur determined fat fraction (VDFF).

专注于POC超声波的Sonic Incytes Medical Corp.已获得美国食品和药物管理局（FDA）510（k）的Velacur测定脂肪分数（VDFF）许可。

The tool, which is integrated into the company’s Velacur device software, combines quantitative measures of ultrasound attenuation and backscatter. It has a correlation coefficient of 0.85, estimating MRI proton density fat fraction (MRI-PDFF), which is the hospital-based gold standard in liver fat measurement..

该工具集成到该公司的Velacur设备软件中，结合了超声波衰减和反向散射的定量测量。它的相关系数为0.85，估计MRI质子密度脂肪分数（MRI-PDFF），这是基于医院的肝脏脂肪测量金标准。。

The company said VDFF provides similar clinical utility to MRI-PDFF at the POC, transforming management of hepatic steatosis.

该公司表示，VDFF在POC上提供了与MRI-PDFF类似的临床应用，从而改变了肝脏脂肪变性的管理。

Sonic Incytes said its VDFF comes at a critical time because it follows the recent FDA clearance of the first metabolic dysfunction associated steatohepatitis (MASH) therapeutic. In addition, the company said recently published clinical guidance by the AASLD recommends liver ultrasound as a secondary screen to blood tests..

Sonic Incytes表示，其VDFF出现在关键时刻，因为最近FDA批准了第一种代谢功能障碍相关脂肪性肝炎（MASH）治疗药物。此外，该公司表示，AASLD最近发布的临床指南建议将肝脏超声作为血液检查的辅助筛查。。

“The approval of Rezdiffra (Madrigal Pharmaceuticals) was a big win for patients, but it also highlighted the urgent need for reliable non-invasive tests (NITs). VDFF is a promising new tool that will arm providers with the data we need to manage and monitor patients at the point of care,” said Dr. Naim Alkhouri, chief medical officer, Chief of Transplant Hepatology, and Director of the Steatotic Liver Program at Arizona Liver Health (ALH) in Phoenix, Ariz..

“Rezdiffra（Madrigal Pharmaceuticals）的批准对患者来说是一个巨大的胜利，但它也突显了对可靠的非侵入性检测（NIT）的迫切需求。VDFF是一种有前途的新工具，将为提供者提供我们在护理点管理和监测患者所需的数据，”亚利桑那州菲尼克斯市亚利桑那州肝脏健康（ALH）首席医学官、移植肝病学主任兼脂肪肝项目主任奈姆·阿尔霍里博士说。。

Sonic Incytes said it expects to release the VDFF feature to new and existing Velacur users in the U.S. via a software update in the upcoming weeks.

Sonic Incytes表示，预计将在未来几周通过软件更新向美国新老Velacur用户发布VDFF功能。