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