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Top 5 FDA-Cleared Apps for Primary Care
From a mobile EKG monitor to a digital urinalysis app, these medical "devices" are changing the way healthcare is delivered.
A mobile app that has received FDA clearance has been evaluated against criteria established for a medical device and is referred to as a mobile medical app (vs a mobile health app). A decision by the FDA to regulate a health/wellness app as a medical device is based on whether the application has the potential to significantly expose a user to health risks if it fails to perform as intended. Thus, neither a calorie counting or fitness tracking app would be considered for regulation.
From the current 100+ FDA-cleared mobile medical apps, our app reviewer chose 5 that physicians and patients can use either coupled with a required medical device or on their own. We highlight:
- A mobile app that allows you to store retinal images to a patient file
- A digital urinalysis app that uses AI to measure a range of conditions
- A menstrual cycle tracking app that uses body temperature to analyze fertility
- An easy-to-use mobile EKG monitor
- A clinically-validated digital assistant for patients with type 2 diabetes mellitus
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