Top 5 FDA-Cleared Apps for Primary Care

March 26, 2019

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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iExaminer™ is a mobile app that couples with the PanOptic™ Ophthalmoscope and allows clinicians to store high-quality retinal images to a patient file.

iExaminer™ is available at iTunes.

Dip.io is an easy-to-use digital urinalysis app that can help early detection of kidney disease, treatment of urinary tract infection, prenatal care, and more.

Dip.io is available at iTunes and Google Play.

Natural Cycles uses a smart thermometer and computer-aided pattern recognition to track fertility and provide guidance on the use of barrier contraception.

Natural Cycles is available at iTunes and Google Play.

KardiaMobile paired with the Kardia EKG device, captures a medical-grade EKG anytime which patients can then send to their primary care physician or cardiologist for further evaluation.