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FDA scrutiny of WHOOP signals challenges for niche wearable device makers (Dec 3)

(Corrects December 3 story to change the surname of doctor in paragraph 16 to Lopez-Jimenez from Jimenez-Lopez) By Puyaan Singh and Sneha S K Dec 3 (Reuters) - Niche fitness-tracking firms such as ...
MD&M East

To Be or Not to Be (a Medical Device): FDA Vs. WHOOP

On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...

Is Amazfit’s $99 subscription-free tracker a challenger to Whoop’s $200 a year band? I found out

Earlier this year, however, Amazfit, known for its budget-friendly fitness trackers, debuted the helio strap, which costs just $99 with no subscription required. (You can upgrade to a $69.99 ...
GQ

The Whoop 4.0 Wants to Be Your Always-On Personal Trainer

Heads up: The Whoop 4.0 and more fitness trackers are on sale right now during Amazon's Big Spring Sale. Health and sleep trackers have been around for longer than you’d think, but they've only ...
Reuters

FDA scrutiny of WHOOP signals challenges for niche wearable device makers

Dec 3 (Reuters) - (This Dec. 3 story has been corrected to change the surname of the doctor to Lopez-Jimenez from Jimenez-Lopez in paragraph 16) Niche fitness-tracking firms such as WHOOP are coming ...
telecom.economictimes.indiatimes

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 ...