Questions about FDA's AI push

The Food and Drug Administration last week announced an aggressive initiative to use artificial intelligence to aid in scientific reviews across the agency. Commissioner Marty Makary touted the ability of the technology to "reduce the amount of non-productive busywork" done by agency personnel.

But as STAT's Katie Palmer and Casey Ross report, the race to use AI as part of the approval process for products that are used by millions of people raises a number of questions, not the least of which is: How exactly does FDA plan to safely roll this out broadly by June?

medical devices

Elizabeth Holmes' blood testing dream lives on

Elizabeth Holmes' partner Billy Evans has been courting investors for a blood testing startup called Haemanthus, the New York Times reported. The company is still operating in stealth, but a prototype bears a striking resemblance to the boxy devices developed by Holmes' company Theranos. She was ultimately convicted of fraud allegations in 2022. There are some differences in how the new company is positioned. For example, it plans to provide testing, at least initially, for people's pets.

Following the revelation, observers responded with a mix and shock and skepticism. An X account for Haemanthus denied that this was "Theranos 2.0," but many can't help but see just that. "It's kind of astonishing to see someone so close to that previous debacle trying to launch something so similar," said Vikas Saini, president of the Lown Institute, a nonpartisan think tank that often spotlights waste in the U.S. health care system.

research

OpenAI jumps into the health AI fray

OpenAI on Monday released a large dataset for evaluating how well large language models answer questions related to health care. It's one of the company's most overt movements toward a health care market that's seen aggressive adoption of many products that use OpenAI technology as a foundation.

Called HealthBench, the dataset contains 5,000 "realistic health conversations," each with a custom rubric to grade a model's responses to health-related questions. As STAT's Brittany Trang reports, the dataset offers researchers and developers a tool to test how different models perform that's better than simply asking questions from the medical licensing exam. Of course, with the data out there, it may be easier for developers to tailor their models to perform well on the benchmark, and it's just one step in making sure that a model is appropriate for use in health care.

business

Omada filing reveals revenues and losses

As long anticipated, Omada Health filed to go public on Friday. The company offers digital programs to help people manage chronic disease. Omada was founded in 2011 and started out working on obesity and prediabetes before creating programs around diabetes, hypertension, and musculoskeletal health.

The biggest revelation in the filing is a first official look at Omada's finances. As the company warns: "We have a history of net losses, and we may not achieve or maintain profitability in the future."

In 2023 Omada's revenues were $122.8 million but it lost $67.5 million.
In 2024 Omada's revenues were $169.8 million but it lost $47.1 million.
In the first three months of 2024, Omada's revenues were $35.1 million, compared to $55 million in the same period in 2025. Its losses for the beginning of 2024 and 2025 were $19 million and $9.4 million, respectively.

Omada sells primarily to employers who offer Omada to their workers. As STAT's Bob Herman pointed out in Health Care Inc, 60% of the company's revenue so far this year comes from Cigna. Notably, the insurer's subsidiary Evernorth has been an important client for Omada's new(ish) GLP-1 care track.

The best take I've seen so far comes from Redesign Health's Neil Patel, who analyzed how both Omada and Hinge Health deal with artificial intelligence in their filings. He points out how costs could increase for both companies if regulation of AI steps up. He also notes that as AI creates more efficiency, customers may want to share in the savings.

If you've got a good take or a question raised by the Omada filing, reach out: mario.aguilar@statnews.com.

wearables

Whoop beats the pack to blood pressure wearable

Wearable maker Whoop last week announced a complete overhaul of its product line, introducing new features accessible at different monthly subscription prices. Many of the features, like FDA-cleared atrial fibrillation screening, and "healthspan," a proprietary metric assessing your body age, mirror offerings available from other device companies. But Whoop appears to be the first well-known wearable vendor to offer a blood pressure tracking. The company's new "MG" (medical grade) wearable, available for $359 per year, offers users a daily look at overnight systolic and diastolic blood pressure.

Providing a reliable measurement of blood pressure without using a cuff is challenging. Whoop hasn't published anything peer-reviewed on its methods but told me its algorithm uses "sensors that track heart rate, heart rate variability, and blood flow patterns, combined with demographic information." The feature only works after a user has logged three readings from a traditional blood pressure cuff. Whoop is careful to position its blood pressure readings as a wellness feature with disclaimers that it's not a medical device and should not be used to manage or diagnose disease.

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