Breaking News: On Friday, Semler Scientific, Inc. filed its annual 10-K report with the SEC, finally revealing that the Department of Justice (DOJ) has been investigating the company for fraud related to their QuantaFlo device. Even more interestingly, the DOJ is currently negotiating a settlement with Semler. It’s remarkable how, despite AI and large language models crawling the web constantly, it took them roughly three days to detect this deeply buried footnote in Semler’s disclosure. Clearly, Semler tried hard to hide it, but STAT News broke the story, and other outlets quickly picked it up.
Here is the relevant paragraph from Semler’s SEC filing:
“In July 2017, we received an initial civil investigative demand, or CID, from the DOJ pursuant to the federal False Claims Act investigating whether we and others may have violated the False Claims Act by marketing tests on devices that use photoplethysmography technology as reimbursable by Medicare in alleged contravention of applicable laws and regulations. We cooperated with the investigation, along with subsequent CIDs received in February 2019, December 2021, April 2022 and April 2023 addressed to our company or individual current or former employees related to the same investigation. In September 2024, DOJ shared certain information to which we responded in January and February 2025. On February 6, 2025, DOJ asked if we wished to engage in settlement discussions to resolve any potential claims by February 11, 2025 and if so that we make a settlement offer by such deadline. Prior to February 6, 2025, DOJ had not stated an intention to pursue a claim of wrongdoing against our company. On February 11, 2025, we began initial settlement discussions with DOJ, but ceased initial discussions on that date. Accordingly, there is a risk that DOJ will file a complaint or complaint in intervention in a civil False Claims Act lawsuit seeking damages. We do not believe the amount of loss can be reasonably estimated. We intend to vigorously defend ourselves in any such action.”
The timing is peculiar—all of this unfolds just five days after my Semler’s QuantaFlo investigation dropped. Coincidence? Maybe.
Semler’s stock price, already down after my initial investigation published on February 24, took another sharp dive following the DOJ news.
Now we know there was a parallel investigation underway by the DOJ. Good for them—but I’m not thrilled about the settlement talks. Unfortunately, settlements like these have long been business as usual under both Republicans and Democrats—consistently bowing to lobbyists and resolving corporate fraud cases for embarrassingly small sums. I genuinely hope it doesn’t happen here.
What makes this case different, as my research revealed, is that it’s not only about Semler. It’s about the entire ecosystem enabling this fraud, extending up through big health insurers themselves. As shown in the org chart within my investigation (which was just a fraction of the full picture), several companies distribute and market Semler’s QuantaFlo device and similar products. Companies like Matrix Medical, Signify Health, Medtronic, Becton Dickinson, UnitedHealth, Aetna, and Blue Cross Blue Shield have directly profited from this fraud.
Most importantly, beyond financial fraud, there’s also real, physical harm being done to patients.
My investigation uncovered that Semler’s QuantaFlo device produces approximately 8 times more false positives than the industry standard, leading to unnecessary medical procedures. Most of these procedures are routine—but occasionally they lead to serious complications. I’ve learned of at least one tragic case where a military veteran, who never had peripheral artery disease (PAD) to begin with, underwent unnecessary atherectomy that resulted in an amputation. I sincerely hope the DOJ investigates cases like these.
Moving forward, as more information continues to come in (thanks to everyone who shares!), I’ll keep quietly updating my original investigative piece—avoiding clickbait posts while ensuring new information is transparently shared.
Thank you for your support. Today is a victory for the medical community—and for everyone who believes in maintaining integrity in clinical products.
Usual disclosure: I have no financial or other stake in any company mentioned in my investigation, regardless of whether they succeed or fail. I’m just here to report the facts.
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