A product photograph of the QuantaFlo device attached to a laptop and imposed over a bright blue illustrated background
Cleared in 2015 through an FDA pathway that requires limited testing, QuantaFlo calculates artery blood volume by measuring reflected infrared light through sensors placed on a patients’ fingers and toes.STAT

By Lizzy Lawrence

April 16, 2025

FDA Reporter

Lizzy Lawrence

[email protected]

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53.

Semler Scientific has offered to pay the Department of Justice nearly $30 million to settle federal health care fraud claims related to its peripheral artery disease test, QuantaFlo — a product used by UnitedHealth Group and other large insurers.

Semler revealed the preliminary agreement in an SEC filing Tuesday, but noted the government could still reject the offer. The deal would cap an investigation Semler first disclosed in February into whether federal health programs paid out improper claims based on the use of QuantaFlo, which would violate the False Claims Act. The DOJ began looking into the company in 2017, according to Semler, but re-upped its investigation in late 2024 and early 2025.

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“Should the parties not be able to reach settlement and DOJ file a complaint, Semler Sci intends to vigorously defend itself in any such action,” Semler wrote. 

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  1. Lizzy Lawrence

    FDA Reporter

    Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53.