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WHOOP has said it will not disable or remove Blood Pressure Insights after the FDA reportedly told the company that the feature makes its wearable operate as a medical device requiring regulatory authorization. WHOOP’s position is that Blood Pressure Insights is a wellness feature and that the FDA lacks authority to regulate it as proposed.
The dispute is not the same as an FDA ban, recall, court order, or final enforcement action. WHOOP continues to market the feature in the United States as part of its $359-per-year WHOOP Life membership, but that availability does not mean the FDA has cleared it or accepted WHOOP’s legal position.
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What happened?
WHOOP introduced the WHOOP 5.0 and WHOOP MG wearable platform in 2025, including Blood Pressure Insights. According to contemporaneous reporting, the FDA told WHOOP in July 2025 that the product was operating as a medical device and required the appropriate regulatory process.
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WHOOP rejected that interpretation. Reporting says the company sent the FDA a letter on August 4, 2025, stating that it would not remove the feature and requesting further discussions. Coverage of the dispute appeared on August 14 and 15, 2025. Techmeme’s contemporaneous roundup identifies the Bloomberg report behind the original coverage, while 9to5Google summarizes WHOOP’s response.
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As of WHOOP’s U.S. product pages reviewed on August 18, 2026, Blood Pressure Insights remains advertised. That establishes continued marketing—not regulatory resolution.
FDA concern versus WHOOP’s position
| Reported FDA concern | WHOOP’s position |
|---|---|
| The feature causes the wearable to operate as a medical device and requires regulatory action. | Blood Pressure Insights is a wellness feature, not a medical device. |
| WHOOP should take prompt corrective action, with possible escalation reported to include seizure, an injunction, or civil monetary penalties. | WHOOP says it will not remove the feature and believes the FDA lacks authority to regulate it in the proposed way. |
These descriptions concern a reported FDA communication and WHOOP’s response. The available sources do not establish that the FDA issued a final enforcement order, that a recall was ordered, that a court ruled on the matter, or that WHOOP has received FDA clearance for Blood Pressure Insights. PCMag’s syndicated report describes the reported letter and possible remedies.
How Blood Pressure Insights works
Blood Pressure Insights is not a conventional cuff reading taken when a user opens the WHOOP app. WHOOP says the feature requires a one-time calibration using a validated traditional blood-pressure cuff. The wearable then uses sensor-derived information—including heart rate, heart-rate variability, and pulse-wave patterns—collected during sleep to produce daily systolic and diastolic estimates or ranges.
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WHOOP describes Blood Pressure Insights as a beta wellness feature. The company says it has not been independently validated or cleared by the FDA. Its explanation of the feature is available in WHOOP’s product article.
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Why could a wellness feature attract FDA scrutiny?
The central question is likely intended use, not simply whether WHOOP calls the feature “insights.” A consumer product can attract medical-device scrutiny when its function, interface, or marketing appears intended to measure or monitor a physiological parameter for a medical purpose.
A disclaimer is relevant, but it does not automatically determine regulatory status. Regulators can consider how a feature is designed, presented, and reasonably understood by users—not only the label attached to it.
Blood pressure is especially sensitive because it has direct clinical significance, including in hypertension management. That makes it different from ordinary wellness metrics such as step counts or general sleep scores. The strongest defensible description is that the FDA reportedly told WHOOP the feature required medical-device treatment; the available evidence does not show a final FDA ruling that WHOOP is violating the law.
Is Blood Pressure Insights still available?
Yes, WHOOP’s current U.S. pages continue to list it under WHOOP Life. WHOOP’s membership information lists WHOOP Life at $359 per year and includes Daily Blood Pressure Insights, ECG and heart-screening features, irregular-heart-rhythm notifications, healthspan features, and priority phone support. The plan includes WHOOP MG hardware, a SuperKnit Luxe band, and a Wireless PowerPack.
Blood Pressure Insights is not listed as a standard benefit of WHOOP One or WHOOP Peak on WHOOP’s current U.S. membership comparison. Availability can change by plan, region, or regulatory market, so buyers should check the relevant local product page before subscribing.
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WHOOP’s Life page continues to describe the feature as non-medical and warns that it should not be used for diagnosis, treatment, or medical decisions. It also says the feature is not intended for people who are pregnant or taking blood-pressure medication.
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Can WHOOP replace a blood-pressure cuff?
No. Blood Pressure Insights should not replace a validated upper-arm blood-pressure monitor.
- Do not use it to diagnose hypertension.
- Do not change, stop, or adjust medication based on a WHOOP estimate.
- Do not dismiss an abnormal cuff reading because WHOOP shows a different result.
- Do not treat a single wearable estimate or trend as proof that blood pressure is controlled.
- Discuss concerning readings, symptoms, or persistent differences with a clinician.
A one-time calibration does not guarantee permanent accuracy. Physiological changes can affect algorithmic estimates, and sleep-only data may not represent daytime, exercise, or medication-related blood pressure. Those limitations do not prove that every estimate is wrong; they explain why the feature should be treated as optional wellness context rather than clinical monitoring.
What “not FDA-cleared” means
“Not FDA-cleared” does not automatically prove that the feature is useless or that every reading is inaccurate. It does mean users should not infer that WHOOP has completed the FDA review associated with a specific medical-device indication.
FDA clearance, FDA approval, authorization, registration, and listing are different regulatory concepts. They should not be used interchangeably. The accurate summary is:
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WHOOP says Blood Pressure Insights is a wellness feature, while the FDA reportedly told the company that the product required medical-device regulatory treatment. The available reporting does not show a final court decision, formal FDA clearance, or resolution of the dispute.
What could happen next?
Several outcomes remain possible, and the available sources do not establish which one will occur:
- Continued discussions: WHOOP and the FDA could exchange information without an immediate product change.
- Presentation changes: WHOOP could change terminology, onboarding, disclaimers, marketing, or the way estimates are displayed.
- Regional restrictions: The feature could become unavailable or be presented differently in particular countries or markets.
- Suspension or removal: WHOOP could later disable the feature voluntarily or in response to further regulatory action.
- Formal submission: WHOOP could pursue an applicable FDA pathway if it wants to position the feature for medical use.
- Enforcement: The FDA could escalate to formal action, including the remedies described in reporting.
There is no basis in the reviewed sources to predict which path the company or agency will take.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What this means for current users
Existing WHOOP users should keep clinical blood-pressure readings in a separate record made with a validated cuff. Blood Pressure Insights may provide additional personal context, but it should not replace the measurements used by a clinician.
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What this means for prospective buyers
WHOOP Life may be a poor fit if the main reason for buying is to diagnose hypertension, monitor blood pressure while taking medication, manage pregnancy-related blood pressure, make treatment decisions, or replace a home cuff.
It may make sense only for buyers who understand that Blood Pressure Insights is a wellness-oriented estimate and who primarily want WHOOP’s broader sleep, recovery, fitness, ECG, and healthspan features. The unresolved dispute is itself a reason not to make the blood-pressure feature the sole justification for a $359 annual membership.
Anyone whose primary need is blood-pressure management should evaluate a validated upper-arm cuff from an established medical-device manufacturer. WHOOP’s feature and a cuff serve different purposes: one estimates trends from wearable signals, while the other is designed for direct cuff-based measurement.
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- Whether the FDA’s communication was a formal warning letter or another type of correspondence.
- Whether WHOOP submitted additional technical or legal evidence.
- Whether the FDA accepted or rejected WHOOP’s response.
- Whether formal enforcement proceedings have begun.
- Whether availability differs across jurisdictions.
- Whether independent clinical validation of the feature has been published.
The clearest current conclusion is narrow: WHOOP is keeping Blood Pressure Insights live, but keeping it live is not the same as winning the regulatory dispute or receiving FDA clearance.
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