FDA scrutiny of WHOOP signals challenges for niche wearable device makers

Niche fitness-tracking firms such as WHOOP are coming under increased regulatory scrutiny as technological advances blur the lines between wearable and medical devices, exposing them to higher compliance costs and hampering their competitive advantage.

Although the U.S. Food and Drug Administration regulates certain health-focused tools in wearable devices such as smartwatches, many companies have until now used a “regulatory gray zone” to bundle apps such as blood pressure monitors under advanced wellness features, without formal approvals.