Top FDA-Approved Mobile Health Apps

With the increased prevalence of smartphones, many healthcare startups are taking advantage of apps to improve patient care. A study found that 325,000 mobile health applications were on the market in 2017, and from fitness to diagnosing illness, the potential of these apps appears to be endless.

Though they may be useful, many of these apps lack funded research and clinical trials supporting their claims. To address this, the FDA has stepped in and began reviewing and approving qualified apps.

The agency implements the same safety-centered approach to approving these apps as they do any other medical device. Their site claims that the approved apps are those that are either intended for use as an accessory to a regulated medical device, or that transform the mobile system into a regulated device. The FDA puts emphasis on the need for review of apps that pose greater risks to patients.

READ MORE: Pear Therapeutics Launches reSET App, First FDA-Cleared Digitally Prescribed Therapy

To showcase some of the industry’s most reliable apps, Docwire has curated a list of our top four mobile health applications approved by the FDA.

MyDose Coach

MyDose Coach is a smartphone app designed for patients with type 2 diabetes who take once-daily insulin. The application allows tracking of fasting blood glucose and contains an insulin dose calculator function as well. Though other insulin dose calculating apps are on the market, a previous study found that 46 of these apps do not accurately do their job.  Being supported by FDA-approval, MyDose Coach is a reliable dose calculating app to use in concert with physician guided insulin recommendations.


This app pairs with the world’s first FDA-approved home spirometer, a device designed to measure air output from the lungs. The device received approval for patients with chronic obstructive pulmonary disease (COPD), and connects wirelessly to the app to provide hospital-quality data regarding breathing. Metrics such as forced spirometry (FVC) and slow spirometry (SVC) are easily collected through this device and app, allowing patients to measure this data in their homes and not a hospital.

Mobile MIM

As one of the first-launched medical apps on Apple’s App Store, Mobile MIM is the first FDA-approved app for viewing images and making diagnoses on MRI, X-ray, ultrasound, and other radiographic scans. The app allows physicians to measure intensity, distances, regions of interest, and annotations all on the smartphone app. These images are transferred from a medical office to the app through a secure server offered by MIM.

Eko Digital Stethoscope

The Eko app connects the stethoscope to the power of the cloud. The app records stethoscope readings, annotations, ECG, and visualizes audioforms generated from the stethoscope. These auditory reports can be synced with the patients electronic health record to seamlessly store comprehensive data. Additionally, these reports can easily be shared with other physicians through the app to allow collaboration and facilitated accessibility.

READ MORE: Google Releases Two New Apps For the Deaf and Hearing Impaired

Source: FDA