Whoop says FDA is ‘overstepping’ with blood pressure feature warning
Logo for Food and Pharmaceutical Administration is seen on April 22, 2025 before the news conference on the removal of synthetic paints from the food supply of America in the Health and Human Services Center on Washington, DC.
Nathan Posner | Anatolia | Getty Images
US Food and Pharmaceutical Administration on Tuesday warning letter The wrist wearable company appeals to WHOOP, claims that it has marketed a new blood pressure feature without appropriate approvals.
The letter focuses on WHOOP’s blood pressure understanding (BPI) feature, which the company introduced with the latest hardware launch in May.
WHOOP said that the BPI feature uses blood pressure information to provide performance and health information that informs consumers and improves athletic performance.
However, FDA said on Tuesday.
“Providing blood pressure estimation is not a low risk function.” He said. “Incorrectly low or high blood pressure reading may have important consequences for the user.”
A WHOOP spokesman offers only one -day estimated range and midpoint of the company’s system, which distinguishes it from medical blood pressure devices used for the diagnosis or management of high blood pressure.
According to the company, WHOOP users who purchase $ 359 “Whoop Life” subscription layer can use the BPI feature to get daily information about blood pressure, including estimated systolic and diastolic intervals.
WHOOP also requires users to record three traditional headlines to the diary to move the BPI feature to the bitch to lock the BPI feature.
In addition, Sözcü said that the BPI data is different from the other health metrics that the company discussed. He said that the spokesperson was allowed in the context of health, as well as medical uses of heart rate and respiratory rate.
“We believe that the agency has exceeded its authority by trying to organize a non -medical health feature as a medical device.” He said.
Dr. Columbia University Hypertension Center, Internal Specialist and Joint Director. According to Ian Kronish, high blood pressure, also called hypertension, is the number one risk factor for heart attacks, paralysis and other types of cardiovascular diseases.
Kronish told CNBC that wearable devices such as WHOOP have a major conversation between hypertension experts, because in part, “concern that these devices are not proven to be correct yet”.
If patients do not receive correct blood pressure readings, they cannot make conscious decisions about the care they need.
At the same time, wearable devices such as Kronish, WHOOP offer a “great opportunity” for patients to have more control over their health, and many professionals are excited to work with these tools.
Conceptly, the ride of consumers can be confusing. Kronish encouraged patients to talk with their doctors to talk about how to use wearable devices such as whooping.
“It is really great to hear that FDA is more involved in informing consumers,” Kronish said. He said.
File Photo: The center of the US Food and Pharmaceutical Administration (FDA) is seen on November 4, 2009 at Maryland Silver Spring.
Jason Reed | Reuters
WHOOP is not the only wearable manufacturer to investigate blood pressure monitoring.
Omron and Garmin Both offer medical blood pressure monitoring with optional readings that are included in the FDA arrangement. Samsung also offers blood pressure reading technology, but it is not available in the US market.
Apple He also mocked a blood pressure sensor for his watches, but he could not deliver it. In 2024, the technology giant received FDA approval for sleep apnea detection feature.
WHOOP has bought it before FDA gap For the ECG feature used to record and analyze the electrical activity of a heart to detect potential irregularities in rhythm. However, when it comes to blood pressure, Whoop believes that FDA’s perspective is antique.
“We do not believe that blood pressure should be considered more or less precise than other physiological metrics, such as heart rate and respiratory rate.” He said. He said: “FDA’s concerns, blood pressure is definitely a clinical field and naturally associated with medical diagnosis can be caused by old assumptions.”
FDA said that if the Whoop could not address the violations determined by the agency’s letter, he could be subject to regulatory actions such as seizures, precautionary measures and civil fines.
Whoop has 15 working days to respond to the company’s steps to address violations, and how to prevent similar problems from being again.
“Even when taking into account the waiver of the BPI, they do not change this result, because the product does not predicate the fact that it naturally aims to estimate a blood pressure estimation with a disease or condition diagnosis.” He said.
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