FDA has strict rules and guidelines on what type of mobile apps can be considered medical device.
FDA currently regulate mobile apps that are used as an accessory for a regulated medical device, i.e. mobile apps that connect to an existing device, such as implantable or wearable devices (sensors, accelerometers, blood glucose meters, treatment lasers, etc.); mobile apps that display, transfer, store, or convert patient-specific medical device data from a connected device, such as nursing station, bedside monitors, imaging devices, and o on; and mobile apps that transform the mobile platform into a regulated medical device by using the device's built-in features such as light, vibrations, camera, or other similar sources to perform medical device functions (mobile medical apps that are used by a licensed practitioner to diagnose or treat a disease).
Here, we listed some of the best mobile apps that have been regulated by FDA and approved as medical devices.
Mobile MIM app is a diagnostic image tool that enables physicians, radiologists, and other healthcare providers to see the radiology diagnostic images on their mobile devices while they're away from their workstation.
Mobile MIM was one of the very first medical apps in Apple's App Store when it first launched back in 2008. FDA officially granted the app a 510(k) clearance in 2011, approving the app as a medical device that can be used for CT, MRI, PET, SPECT, X-ray and Ultrasound imaging.
One of the highlights that make Mobile MIM different from similar apps is MIMcloud, and integrated server that makes the download, storage, and sharing of diagnostic images much easier.
Mobile MIM is available for free but only on iOS.
Our score: 94%
ResolutionMD is another diagnostic imaging tool in this list approved by FDA. It is a client-server architecture product that enables physicians to securely view patient images and reports, collaborate with their colleagues and other providers, and diagnose from any location.
ResolutionMD app streams data from a variety of imaging modalities which all received an FDA clearance, including computed radiography, digital radiography, angiography, radio-fluoroscopy, ultrasound, nuclear medicine, endoscopy, and ophthalmology. The only modality that isn't cleared is mammography.
The app secures sensitive patient information, meaning that it's not transmitted during the processing.
ResolutionMD is available for free on Android and iOS.
iExaminer Pro App by Welch Allyn
iExaminer Pro app by Welch Allyn is one of the mobile apps that connects to an existing device.
The app is used in conjunction with the Welch Allyn iExaminer adapter, which allows ophthalmologists to attach their iPhones to the Welch Allyn PanOptic Ophthalmoscope, in order to capture, store, and retrieve fundus images (images of the inside of the eye) through an undilated pupil in a real time.
Because of the ability to capture photos instantly, iExaminer Pro app can provide prompt telemedicine consultations with an ophthalmologist and quicker preliminary triage answers to the patients.
The app also allows emailing and printing of patient files, without violating patient identity as no external facial features are revealed.
The app free to download, and it's available only on iOS.
Our score: N/A
Kardia app by AliveCor provides the simple way to detect atrial fibrillation early and reduce patient's risk of stroke.
The app works with the FDA-cleared Kardia Mobile device, which is used for accurate electrocardiogram (ECG or EKG) recordings.
Users are instructed to hold Kardia Mobile device in their hands for 30 seconds to capture their EKG. Kardia Mobile then communicates with the Kardia app over a wireless network to notify users if their EKG is normal or if atrial fibrillation is detected.
Patients can easily share their EKG recordings with their physician or request an expert review from a cardiologist or cardiac technician in the app, for an additional cost.
Kardia app is free to download and use on both iOS and Android.
DASH learn App
DASH learn app is an informative resource for orthopedic surgeons performing navigated total knee or hip joint replacement surgery with the DASH Smart Instrument Technology system - a portable surgical navigation system designed to assist orthopedic surgeons in performing knee and hip joint replacement procedures with high accuracy.
The app includes a variety of instructional videos and illustrated how-to guides to provide the necessary information for basic operation and resources to assist surgeons who use DASH system.
DASH learn app is free and it works only with iPhone, iPad and iPod Touch.
Our score: N/A
BlueStar Diabetes App
BlueStar is a comprehensive diabetes app that has received FDA clearance as a Class II medical device.
It enables patients with Type 2 diabetes to record blood glucose results, lead a food diary, organize their medications, sync with activity trackers and OneTouch Verio Flex meter to transfer blood glucose results to receive the guidance from their health care team.
Patients need an access code from their employer, health plan, or health care provider to use BlueStar.
Also, with a prescription from their health care provider, patients can upgrade to BlueStar Rx, which offers an insulin calculator for people who take mealtime insulin.
BlueStar Diabetes app should not be used by people with Type 1 diabetes, gestational diabetes or who use an insulin pump.
The app is available on Android and iOS for free.
AirStrip ONE App
AirStrip ONE app is a mobile platform that enables health care collaboration. It connects clinicians with patient data and with each other, enabling workflow automation and collaboration at the moment of care.
AirStrip ONE app delivers dynamic information that can improve clinicians' ability to assess, monitor and direct care for their patients, regardless of location, specialty, or workflow preference.
The app is cleared for use as a diagnostic aid, providing the confidence that clinical information is accurate and timely, and the privacy of patient data is secure and safe.
AirStrip ONE supports a variety of clinical environments and functionality, including Obstetrics, Cardiology, Patient Monitoring, and EMR.
The app is available for free on iOS and Android.