FDA Classifies Whoop's Blood Pressure Insights as Medical Device
Whoop Inc., the manufacturer of the popular Whoop fitness tracker, has been embroiled in a dispute with the FDA. Last month, the agency informed Whoop that its Blood Pressure Insights feature functions as a medical device, requiring FDA certification. Initially, Whoop disputed this classification, considering it a wellness feature rather than a medical device.
The Whoop tracker, which competes with brands such as Amazfit and Polar, offers a range of features including heart rate monitoring and sleep tracking. However, the Blood Pressure Insights feature, introduced in 2021, allows users to estimate their blood pressure using their heart rate and other data. This feature has drawn the FDA's attention, as it crosses the line into medical device territory.
The FDA's classification has significant implications for Whoop. As a medical device, the Whoop tracker and its Blood Pressure Insights feature will need to undergo rigorous testing and meet strict regulatory requirements to ensure safety and effectiveness. This process can be time-consuming and costly, potentially impacting the device's availability and price.
Whoop Inc. must now comply with the FDA's classification of its Blood Pressure Insights feature as a medical device. This requires obtaining the necessary certification, which may involve substantial effort and resources. The certification process will help ensure the safety and accuracy of the feature, benefiting users who rely on it for health monitoring.
