WHOOP, Blood Pressure and FDA’s New Wellness Framework: What Changed – and What Companies Can Do Now

In July 2025, the U.S. Food and Drug Administration (FDA) told WHOOP, Inc. that its Blood Pressure Insights (BPI) feature was an unapproved medical device. FDA had concluded that BPI’s blood pressure estimation was inherently associated with the diagnosis of hypertension and hypotension and thus not a low risk function eligible for FDA’s 2019 General Wellness policy.

A year later, the regulatory landscape looks materially different. On January 6, 2026, FDA issued a revised General Wellness: Policy for Low Risk Devices guidance expressly contemplating certain low risk products that use non-invasive sensing to estimate, infer, or output physiological parameters – including blood pressure – appropriate for general wellness purposes.

The 2026 guidance is the latest step in a decade-long evolution of FDA’s approach to digital health and wellness – from the Cures Act’s 2016 statutory exclusion for certain wellness software, through FDA’s prior General Wellness policy, to today’s increasingly sophisticated wearables and AI-enabled products.

Then, on June 17, FDA closed out the WHOOP matter. The Agency stated that WHOOP had made changes to BPI and its labeling and, consistent with the updated guidance, FDA no longer intended to enforce device requirements against BPI as modified.

That sequence is more than an interesting enforcement story. It provides an early window into how FDA’s new wellness framework may work in practice – and what it means for companies developing increasingly sophisticated wearables, digital health products, and AI-enabled wellness tools.

Key Takeaways

• FDA’s 2025 position was significant: FDA treated WHOOP’s blood pressure estimation as inherently associated with diagnosis and separately concluded that the function was not low risk.
• FDA’s 2026 guidance changed the policy landscape: FDA now expressly contemplates certain non-invasive products that estimate, infer, or output physiological parameters, including blood pressure, for general wellness purposes.
• WHOOP did not have to eliminate blood pressure functionality: FDA’s closeout confirms that WHOOP modified BPI and its labeling.
• WHOOP says the changes were purely visual and did not change the feature’s benefits. That is WHOOP’s characterization, not an FDA finding, but it raises an important question – how much of the regulatory outcome turned on how the underlying functionality was presented and positioned?
• The new framework is not a blanket exemption for health technology. FDA continues to distinguish wellness functionality from products intended for clinical purposes, including diagnosis, screening, disease monitoring, medical management, or treatment decisions.
• For companies, the regulatory analysis increasingly belongs in product design. The critical questions are not only what a product measures, but what it claims, how it presents the information, what it tells consumers to do, and how future AI functionality may change the intended use.

What FDA Objected to in 2025

FDA’s July 2025 warning letter was unusually clear about why BPI crossed the line. WHOOP represented that BPI provided users with daily systolic and diastolic blood pressure estimations. Its website described BPI as an example of WHOOP delivering “medical grade health & performance insights,” and said that higher blood pressure could be an indicator of poor sleep.

FDA concluded that BPI was a medical device because it was intended to provide a blood pressure measurement or estimation that was inherently associated with the diagnosis of hypertension and hypotension. The Agency also pointed to BPI’s user interface, which displayed the result on a gauge using green, yellow, and orange color coding to indicate a target blood pressure range. WHOOP’s disclaimers did not change FDA’s conclusion, the Agency said, because they could not overcome the product’s design and intended use.

And FDA identified a second problem: blood pressure estimation was not low risk. FDA noted that it actively regulated blood pressure devices and that inaccurate readings could result in inappropriate reassurance, delayed treatment, or other serious consequences. So FDA’s 2025 position was not simply that WHOOP needed to change its marketing. It was that BPI’s very functionality, intended use, and risk profile placed it outside the General Wellness policy.

That is what makes the 2026 development so significant.

What Changed in 2026?

FDA’s January 2026 guidance materially expanded the policy framework for certain wellness products using non-invasive sensing. The guidance states that FDA may consider certain products that use non-invasive sensing to estimate, infer, or output physiologic parameters, including blood pressure, oxygen saturation, blood glucose, and heart rate variability, to be general wellness products as long as those outputs are intended solely for wellness purposes and certain conditions are met.

Of course, those conditions matter. Among other things, the products must be non-invasive and non-implanted, must not be intended to diagnose, treat, cure, mitigate, or prevent a disease or condition, must not substitute for an FDA-authorized device, and must not include claims, functionality, or outputs that prompt or guide specific clinical action or medical management. FDA also says values that mimic clinically used values must be validated to reflect those values.

Yet, FDA also expressly says that qualifying products may display values, ranges, trends, baselines, and longitudinal summaries and may put those outputs into the context of sleep, activity, stress, recovery, and similar wellness domains.

Interestingly, WHOOP’s June 2026 closeout letter did not identify exactly what WHOOP changed. It is only a few paragraphs long and does not identify which claims, displays, features, or other elements changed. WHOOP, however, supplied an additional piece of the story. According to Fierce MedTech, a company spokesperson said WHOOP made “proactively targeted modifications” to BPI and its labeling that reinforced the feature’s wellness purpose and characterized the changes as “purely visual” and not interfering with the feature’s benefits.

That characterization is revealing: this means the feature did not have to stop generating blood pressure estimates to obtain FDA’s closeout. Instead, the product was modified in ways that were visual and positioning-oriented. That is the regulatory shift companies should be paying attention to.

The Regulatory Shift at a Glance

The lesson is not that FDA has declared blood pressure wearables to be wellness products writ large. More precisely, FDA has created more room for companies to use physiologic data in wellness products – if they design and position the product to stay within that space.

What Can Companies Potentially Do Now?

This is where the guidance beomes commercially significant. Under FDA’s 2025 position, a company could not comfortably rely on the General Wellness policy for a non-invasive product that estimated blood pressure simply because the company characterized the feature as wellness, because FDA viewed a blood pressure estimation as inherently associated with diagnosis irrespective of the company’s marketing claims and therefore the function was not low risk.

Under the 2026 framework, however, it appears the association is no longer inherent – a company may now develop a non-invasive product that estimates a physiologic paramater and provides values, ranges, trends, baselines, or longitudinal summaries as a wellness product, not a medical device.

A company now has more room to:

• provide a physiologic estimate in a wellness context;
• show trends or longitudinal changes;
• contextualize those outputs with sleep, activity, stress, or recovery;
• provide general wellness information about those outputs; and
• notify a user that consulting a healthcare professional may be helpful in appropriate circumstances, so long as the notification does not become a disease-specific or clinically directive alert.

The Medical Device Path Has Not Disappeared

There is another development that makes the regulatory landscape even more interesting. In January 2026, FDA also issued draft guidance addressing clinical performance testing and evaluation for cuffless non-invasive blood pressure measuring products submitted as medical devices. The guidance is directed at premarket submissions and reflects FDA’s continuing regulation of cuffless BP technology when it is intended for medical use.

Taken together, the two January developments make the regulatory fork clearer. The same general category of underlying technology can potentially occupy different regulatory pathways depending on intended use, claims, functionality, and risk. One product may be designed to provide wellness-oriented physiologic information. Another may be intended to provide clinically meaningful blood pressure measurements for diagnosis, monitoring, or treatment decisions. The technology may overlap, but the regulatory analysis does not. That makes product positioning more than a marketing decision. It can be a regulatory decision.

The Consumer Is More Informed – and AI Changes the Equation

There is another reason this distinction deserves more attention. The consumer receiving health information today is operating in a radically different information environment from the consumer of decades ago.

Wearables, telehealth, patient portals, health apps, search engines, and AI tools have made health information ubiquitous. A consumer receiving a physiologic estimate from a wearable can immediately research it, compare it with other information, ask an AI system to explain it, discuss it with a healthcare professional, or simply decide not to act on it. Consumers are also more sophisticated in their understanding of the relative weight of information from different sources. While their sophsitication does not eliminate a company’s responsibility for misleading claims, FDA may now recognize that consumer understanding should not be evaluated in a vacuum.

FDA’s revised guidance focuses heavily on the product’s labeling, advertising, user interface, and functionality. It recognizes that it is reasonable for a consumer to receive physiological outputs and even certain notifications from wellness products so long as those communications do not cross into diagnosis or specific medical management.

As AI becomes embedded in these products, that analysis becomes even more important. The regulatory question is increasingly not just:

What does the product measure?

but

What does the product tell the consumer that the measurement means?

What This Means for Product Teams, Investors, and Boards

The practical implication is that FDA strategy increasingly belongs upstream of commercialization.

Product teams should ask:

What are we estimating? What physiologic parameter is being generated, and what are the consequences if the output is inaccurate?

What are we saying it means? Do labeling, advertising, app store descriptions, notifications, and user-facing copy consistently support a wellness purpose?

What does the product tell the consumer to do? Does it provide information or does it identify a clinical threshold, generate a disease-specific alert, or recommend medical action?

What will the consumer understand from the entire experience? Beyond a disclaimer, interface design, color coding, terminology, notifications, claims, and surrounding context can all shape intended use.

Be Mindful of Product Creep and Regulatory Debt

The nature, and often mission, of tech is to evolve, and wearables are no different. What happens to each update? Will the next algorithm, notification, or recommendation change the regulatory analysis?

These questions will also matter to investors and acquirers. A wellness company’s regulatory profile should be diligenced against what the product does today and what management intends to build tomorrow. A product that fits comfortably within the wellness framework today can accumulate regulatory debt if its roadmap steadily adds disease-specific insights, clinical recommendations, or AI-generated concludsions without revisiting the underlying regulatory strategy. At least until FDA’s future wellness guidances catch up with the next generation of sophistication, companies in the space need to keep an eye on the the agency’s current comfort level. Vedder’s Regulatory Strategy & Compliance Practice advises wellness and life sciences companies and their strategic partners on FDA requirements, product and promotional strategies, and practical compliance programs in rapidly evolving markets. Vedder helps clients evaluate regulatory risk proactively and develop business-focused strategies that support product development, commercialization, and growth.