Wearables – including consumer products like FitBit wristbands and smartwatches – are quickly moving beyond their use as wellness products that track steps and sleep patterns to incorporate serious medical device capabilities and clinical applications.
In September 2018, the Apple Series 4 model smartwatch became the first such product to have its software officially designated by the U.S. FDA as a Class II medical device. Specifically, the FDA granted clearance to the smartwatch’s incorporated electrocardiogram (ECG) that alerts its wearer to abnormal heart rhythms. Since then, Verily (the life sciences arm of Google’s parent company, Alphabet) has also received FDA clearance for an ECG, incorporated into its prescription-only smartwatch, and Withings (formerly Nokia’s health business) has unveiled a smartwatch with an ECG feature.
ECGs are far from the only new consumer wearable applications providing medical value. The Apple smartwatch also incorporates an accelerometer and gyroscope that can detect a hard fall by analyzing wrist trajectory and impact. When such a fall is detected, the watch sends the user an alert that can be forwarded as a call for help. If the watch detects no movement within 60 seconds after the fall, it automatically alerts emergency services. Additionally, another medical app incorporated in several of the new wearables analyzes the wearer’s heartbeats for irregularities above or below a certain threshold and alerts the user if there are signs of atrial fibrillation. Still other apps monitor heart rate and alert the wearer to seek medical attention if significant anomalies are detected.
More products and applications are coming. Based on recently issued patents, Apple is rumored to be redesigning its wireless earbuds to include new health features like biometric sensors that monitor the user’s heart rate and temperature, and Google was also recently awarded a patent for in-ear health monitoring technology. Microsoft was issued a patent for wearable sensors on eyeglasses that continuously analyze pulse waves from three locations on the wearer’s face to monitor blood pressure. Verily has reportedly been working on embedding health-tracking sensors into shoes to monitor movement, weight, and falls.
Industry analyst CCS Insight predicts that the worldwide sales of wearable medical products will grow to become a $29 billion market by 2022, and that the capabilities of such devices are on track to increasingly offer clinical-grade patient data that physicians can use to make diagnoses.
The FDA has also responded to this rapidly advancing field of technology by introducing its Digital Health Innovation Action Plan. This is a precertification program aimed at speeding up the approval process for digital health software that poses a lower health risk than traditional medical devices. Somewhat unusually, it is a tailored approach that looks first at the developer of the digital health technology or software rather than at the specific product. Once a developer is pre-certified, they can market their lower-risk medical technology offerings without further FDA review or with a much less onerous pre-market review than the one faced by many traditional medical devices.