5 Apps Approved and Regulated by the FDA
- YuGo Microsoft Kinect
- Clarius Scanners
- Quell
- Wing
- AgaMatrix Diabetes Manager App
FDA regulation of medical apps might seem nonsensical. Why is the Food and Drug Administration monitoring cell phone apps? Modern medical apps can display ultrasound results, walk users through treatment regimens or store years of patient’ data. As these five advanced medical apps show, FDA regulation protects consumers from potential false advertising or outright harmful interventions.
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1. YuGo Microsoft Kinect
Gamification has come to medical apps. YuGo lets physical therapists create fun video game workouts for clients. Microsoft’s Xbox tracks exercise and automatically logs it for the patient and therapist. The app shows on-screen examples of how to do each movement, so patients can keep their form sharp. Through the Kinect’s motion-tracking sensor, the Xbox can also provide real-time feedback for struggling patients. Providers hope this FDA-approved app can increase patient compliance with physical therapy routines. Similar products have been developed by Reflexion Health and Jintronix.
2. Clarius Scanners
House calls might make a comeback with this technology. Now, physicians can carry portable ultrasound scanners anywhere they go and receive the results to any Android or Apple phone. Scans are stored on the secured Clarius Cloud, which allows providers to review results anywhere. Although primarily useful for doctors, this is good news for bedridden patients or anyone else who finds frequent office visits a challenge.
3. Quell
Quell is a wearable, app-controlled pain management device. It works on the same principles as TENS units, sending small electric shocks to sensory nerves. These nerves tell the brain to stop processing pain. Patients get quick, drug-free relief. A Quell device is worn on the upper calf where pants or a long skirt can hide it. The signals sent to the nerves are controlled through the user’s phone, where regular therapy sessions or one-time relief can be scheduled. Quell also sends de-identified data to pain management researchers to improve clinical understanding of chronic pain. According to Quell, this is the only FDA-approved app for over-the-counter pain management.
4. Wing
Sparo Labs developed Wing to help patients with asthma and other chronic lung conditions. Users plug Wing into a smartphone then exhale into the device, which measures volume and force. The app tracks data with every use, eventually building a custom profile for each user. Patients can predict when they’ll have asthma attacks and use their inhalers before an attack hits. The FDA gave Sparo Labs clearance to market Wing over-the-counter and directly to consumers, which is one of the least-restrictive regulations.
5. Jazz Wireless
The AgaMatrix app is regulated by the FDA for wireless blood monitoring. Users purchase the Jazz blood glucose monitor and use it to read diabetic test strips. Results are sent via Bluetooth to iPhone or Android devices and automatically stored. Patients can share trends with providers and have easy access to their glucose results in the palm of their hands. The app can also monitor weather, carbohydrates, weight and insulin. Data can be stored on the company’s server and accessed across multiple devices.
Most of these FDA-regulated apps connect with external medical devices and provide regular treatment or monitoring of medical conditions. The FDA wants to protect consumers from false claims and faulty products. In that light, FDA regulation of medical apps makes sense.
