DentRx
Jan 20, 2026
Smart watch tech approved for medical device category
Many wearables that can check physical activity, heart rate, and heart rhythm are available to consumers. Companies like Apple, Samsung, Fitbit, and others make wearable products and medical device software that can identify heart diseases or arrhythmias, like atrial fibrillation (Afib), and give people wearing them an alert when anomalies are detected. While these wearables are not meant to provide diagnoses, when problems are found and doctors and/or patients are notified, doctors can prescribe tests, drugs, or other treatments to prevent health problems like heart failure or stroke. The FDA has authorized the software functions used with these wearable products so that they can be legally marketed and sold without a prescription.
