Devices and Apps Which Already Have FDA Approval
The FDA guidelines which were recently published have required FDA approval for certain types of apps and mobile attachments which are essentially designed to function as medical devices which would have otherwise required FDA clerance. Here are some FDA approved programs which are a great model for future devices/apps.
Alivecor Heart Monitor
Once upon a time, electrocadiogram (ECG) monitors were a rare luxury that only the most prestigious clinics offered. Today, doctors depend on this technology to monitor heart health, and the recently approved Alivecor Heart Monitor makes it easier than ever. The monitor hardware is a custom-designed case available for the iPhone 4, 4s and 5 and Samsung Galaxy S4. It can also function with a universal plate that syncs with the previous devices as well as the HTC One, Galaxy S3 and iPod Touch 5. At $199, the Alivecor monitor is an affordable and reliable ECG monitor.
Developer Materialise specializes in 3D software that enables doctors to plan procedures, and now that technology has come to the iPad. Surgicase Connect is a free interactive tool that uses the iPad’s unique capabilities to help doctors review surgical procedures. Doctors can load medical image data to the program and manipulate the rendered image as if they’re in the operating room. As you plan execution of the procedure, Surgicase Connect enables you to make notes and approve plans. It’s an unprecedented combination of performance and convenience for iPad users.
Teleradiology was one of the first medical functions to make the shift from analog to digital, and now that shift is going mobile. Aycan Mobile delivers DICOM images from hospitals and imaging centers directly to your iPad. High-definition images come in large files, so a high-speed Internet connection will deliver best performance when transferring data. Once the images are uploaded to the program, doctors have access to a range of processing capabilities including zoom and pan. Aycan mobile’s 256-bit encryption protects patient information and delivers images over a secure network. This app is free for Aycan users and syncs with the desktop app.
Withings Blood Pressure Monitor
Your nurses have enough on their plates. Let technology handle a common medical formality with the Withings Blood Pressure monitor. This device plugs into your iPhone, iPad or iPod Touch and accurately records blood pressure and heart rate. This Withings device was initially released for the iPhone 4, but a simple 30-pin-to-lightning cable adapter enables it for use with the latest iPhones. It takes minutes to set up and has been declared accurate by the FDA and independent parties. The Withings Blood Pressure Monitor costs $129.95.