A product photograph of the Quantaflow device plugged into a laptop computer on a plain white background
The QuantaFlo device plugged into a laptop.

By Lizzy Lawrence and Casey Ross

March 3, 2025

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.

Casey Ross

[email protected]

Casey Ross covers the use of artificial intelligence in medicine and its underlying questions of safety, fairness, and privacy.

The Department of Justice is investigating Semler Scientific for possible violations of a federal anti-fraud law related to its marketing of a product known as QuantaFlo, a test used in the diagnosis of peripheral artery disease by UnitedHealth Group and other large insurers.

In a recent filing with the Securities and Exchange Commission, Semler disclosed that the government is investigating the use of QuantaFlo related to claims made for reimbursement from government health programs, which in some cases pay insurers more money to cover patients diagnosed with peripheral artery disease. 

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The SEC filing states that on Feb. 11, Semler began — but then cut off — settlement discussions with the Department of Justice related to possible violations of the False Claims Act, an anti-fraud law designed to prevent companies from collecting unwarranted payments from the federal government. The company indicated that the investigation began in 2017 and picked up in intensity in late 2024 and early 2025. 

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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.

  2. Casey Ross

    Chief Investigative Reporter, Data & Technology

    Casey Ross covers the use of artificial intelligence in medicine and its underlying questions of safety, fairness, and privacy.