FDA Recognizes New Apple Watch as Medical Device

The New Apple Watch Series 4 is an FDA class 2 medical device that detects falls and monitors hearts.

Apple Watch Presentation / Image: Getty
Apple Watch Presentation / Image: Getty

A recent Forbes article discussed updates to the Apple Watch that garnered it a class 2 medical device classification from the FDA. The Apple Watch Series 4, unveiled last week, can detect falls and has three new heart monitoring capabilities.

The internal accelerometer and gyroscope analyzes wrist trajectory and impact acceleration to determine when a fall occurs. It then delivers an alert from which the wearer can initiate an emergency call. If the wearer is immobile for more than 1 minute, it will make the call automatically and send a message with your location to your emergency contacts.

The built-in optical hearts sensor has been a feature of the Apple Watch since day one, but has gains more capabilities with each new release. The most recent version features a low heart rate alert, heart rhythm detection, and personal electrocardiogram monitoring.

Fresh from the show floor: pharma packaging innovations for 2026
Serialization mandates. Containment demands. Sterile barrier requirements. Our editors found the pharma packaging innovations addressing your biggest challenges at PACK EXPO Las Vegas. Get your free curated report now.
GET YOUR COPY
Fresh from the show floor: pharma packaging innovations for 2026