Apple’s Latest Watch Receives FDA Approval For ECG Functionality

Since its first release in 2015, the Apple Watch has continued to evolve and incorporate more health- and fitness-tracking capabilities. The latest version of Apple’s Watch—Series 4—features a larger display screen, thinner case, a new interface, and, according to Apple “revolutionary health capabilities.” These health capabilities include electrocardiogram (ECG) functionality, which has been granted approval by the U.S. Food and Drug Administration. Also incorporated into the latest version of the Watch, according to Apple, are a new accelerometer and gyroscope that allow for fall detection.

Jeff Williams, Apple’s chief operating officer, stated:

The completely redesigned Apple Watch Series 4 continues to be an indispensable communication and fitness companion, and now with the addition of groundbreaking features, like fall detection and the first-ever ECG app offered directly to consumers, it also becomes an intelligent guardian for your health.

Apple notes that its Series 4 Watch allows wearers to place their finger on a dial for 30 seconds and receive a heart rhythm classification, which can identify if the wearers’ heartbeat is following a normal or irregular pattern. Irregular heart beat patterns, often referred to as Atrial fibrillation, increase the risk of heart complications. Recordings of such heart rhythm information are stored in a Health app and can be shared with physicians via a PDF file.

Some commentators believe the fall detection capabilities of Apple’s Series 4 Watch may prove significantly valuable, especially for elderly wearers. The Series 4 Watch is said to incorporate a new accelerometer and gyroscope which measure up to 32 g-forces and utilizes “custom algorithms to identify when hard falls occur.” The Watch also analyzes trajectory of the wearer’s wrist and the impact of accelerations, and sends an alert to the wearer after a fall event. Such alert can be dismissed or used by the wearer to make an emergency call to a healthcare provider. According to Apple, if the Watch senses a lack of movement for one minute after the alert notification, an automatic emergency call is made and a message is sent to emergency contacts along with location data.

 

Aaron Johnson
Aaron S. Johnson is an associate in the firm's Orange County office. His practice includes patent prosecution, IP litigation, and due diligence. Aaron received his Bachelor of Science in Civil Engineering from the University of California, Irvine. Aaron later received his Master of Science degree in Civil Engineering from the University of California, Berkeley, specifically within the Structural Engineering, Mechanics, and Materials Department (SEMM). Aaron's master's thesis involved research and analysis of seismic base isolation systems. While at UC Berkeley, Aaron worked as a graduate student instructor for first-year students majoring in mechanical and civil engineering. After graduating, Aaron worked as a structural engineer and earned his professional engineer license. Aaron earned his law degree from the University of California, Irvine, where he served as a teaching assistant for a first-year Lawyering Skills course and as a research Editor on the UC Irvine Law Review. Aaron also worked at the UCI Intellectual Property, Arts, and Technology Clinic. Mr. Johnson worked as a summer associate in 2016 before joining the firm as an associate in 2017.
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