Medical technology3 min read
Wearables and remote monitoring
Wearables such as smartwatches carry sensors that track and transmit data such as heart rate. They are often used to monitor and self-manage chronic conditions, and range from general-wellness gadgets to FDA-regulated medical devices.
According to the FDA, digital health technologies range from general wellness apps to apps that count as medical devices, and FDA-approved devices are being updated with digital features. A research example is a phone app designed for patients with atrial fibrillation.
NIBIB notes that many advanced sensors are not yet practical for routine medical care, although they allow researchers to study health. The distinction matters between a consumer wellness device and a cleared medical device; readings from the former are not treated as a diagnosis.
- In widespread clinical use
- Approved for specific uses
- In clinical trials
- Preclinical
- Concept
Some are medical devices cleared for specific purposes, and many are general wellness tools; advanced sensors are mostly for research.
- Monitoring and self-management of chronic conditionsApproved for specific uses
Wearable devices often use sensors for this purpose.3
- Advanced sensorsPreclinical
Many are impractical for routine care, but useful for research.2
Status last checked: · What the maturity levels mean
What is it?
Sensors are tools that detect inputs from the environment and respond to them; wearable technologies such as smartwatches carry sensors that track data such as heart rate, analyse it and send it.
How does it work?
The data are sent to phone apps that may allow remote monitoring and are used with telehealth and mobile health.
Where is it used today?
Wearable devices often use sensors to monitor and self-manage chronic conditions, and a research example is an app for patients with atrial fibrillation (one of the heart rhythm disorders).
Digital health technologies range from general wellness apps to apps that count as medical devices, and digital features are being added to FDA-approved devices.
Limits and risks
Many advanced sensors are not yet practical for routine medical care.
A reading from a consumer wellness device is not treated as a diagnosis; discuss any worrying reading with your doctor.
Common questions
Is my smartwatch enough to diagnose a heart problem?
No. Many of these devices are general wellness tools, and any worrying reading needs the doctor's assessment and tests.1
Questions for your doctor
- Is the device I use medically cleared for what I use it for?
- How do I share my device's data with my doctor safely?
References
- 1U.S. FDA. What is Digital Health?. www.fda.gov/medical-devices/digital-health-center-excellence/what-digital-healthHealth agencies & guidelines · Accessed 2026-10-08
- 2NIBIB (NIH). Sensors. www.nibib.nih.gov/science-education/science-topics/sensorsHealth agencies & guidelines · Accessed 2026-10-08
- 3NIBIB (NIH). Digital Health. www.nibib.nih.gov/science-education/science-topics/digital-healthHealth agencies & guidelines · Accessed 2026-10-08
Review status: Edited content · Last updated:
Change log
- — Page created.
Educational content only — no diagnosis, and no substitute for a clinician.