New health gadgets are becoming more connected, portable, and capable of collecting health and wellness information. Modern devices can include smartwatches, health rings, wearable patches, glucose monitors, sleep tracking systems, and other sensor-based technologies. The FDA maintains information on authorized sensor-based digital health devices, including wearable products designed for continuous or occasional health monitoring outside clinical settings.
Health gadgets include consumer wellness products and regulated medical devices that use sensors, software, connectivity, or other technologies to collect health-related information. The FDA describes digital health technologies as covering areas such as wearable devices, mobile health, telehealth, and connected software.
Examples include:
The capabilities and medical status of each device can vary significantly.
Many newer devices use small sensors to collect information about movement, heart activity, sleep, temperature, or other physiological measurements. Some can send information to a smartphone or healthcare platform.
The FDA's current sensor-based digital health list includes wearable technologies such as smartwatches, rings, patches, and bands designed for continuous or spot-check monitoring.
Potential uses include:
Not every consumer gadget is intended to diagnose or treat a medical condition.
Artificial intelligence is increasingly being incorporated into healthcare technology. AI can help analyze information, recognize patterns, and provide data that may support healthcare professionals.
The FDA maintains a list of AI-enabled medical devices that have met applicable premarket requirements.
AI-related applications can include:
The FDA is also developing approaches for newer AI-enabled technologies, reflecting the rapid development of digital healthcare tools.
The newest gadget is not necessarily the most appropriate choice for every person. Before using a device for health-related purposes, research what it is actually designed to measure and whether it has been evaluated for that intended use.
Consider:
The FDA notes that its sensor-based device list includes products that met applicable premarket requirements, but also states that the list is not comprehensive.
A health gadget can provide useful information, but measurements should be interpreted according to the device's intended purpose. A wellness tracker should not automatically be treated as a diagnostic medical device.
Before relying on information from a device:
The FDA notes that digital health technologies can help move healthcare into home settings and support real-time information collection outside traditional clinical environments.
New health gadgets are evolving through wearable sensors, connected devices, remote monitoring, artificial intelligence, and mobile health technology. Current FDA resources include authorized sensor-based devices such as smartwatches, rings, patches, and monitoring systems, demonstrating the growing role of digital technology in healthcare.
When researching a new health gadget, consider its intended use, accuracy, regulatory status, privacy protections, compatibility, and available evidence. Understanding the difference between general wellness products and regulated medical devices can also help set realistic expectations.