Commercially successful mHealth devices are ones that leverage data from the cloud and external sensors automatically, a prominent technologist writes in MD+DI online. Liam Pender, CEO of product design and engineering firm Egret Technoliges, points to continuous glucose monitoring systems designed to measure glucose levels in real-time, 24/7.
In the case of continuous glucose monitoring systems, a tiny electrode called a glucose sensor is inserted under the skin to measure glucose levels in tissue fluid. It is then connected to a transmitter that sends the information via wireless radio frequency to a monitoring and display device.
"We are putting Bluetooth Low Energy (LE) radios in lots of medical devices that allow them to connect to smartphones," Pender writes. "The smartphone is being used as both a wireless gateway to the cloud and also as a user interface to interact with the attached medical device."
Two devices that Pender's company has worked on for clients involve continuous glucose monitoring (CGM):
- The Dexcom G4 Platinum provides diabetic patients with accurate CGM data as well as extended wireless range
- Boston University and Massachusetts General Hospital conducted clinical trials on children with Type I diabetes for an artificial pancreas that tied together insulin pumps, CGM sensors and an iPhone running a closed-loop algorithm
Last year, an Egret Technologies client filed a Bluetooth LE-enabled medical device submission to the U.S. Food and Drug Administration. The device is based on a Nordic Semiconductor Ultra Lower Power radio transceiver implementing the Bluetooth 4.0 protocol for low-power, long-running sensors that don't require frequent recharging.
In related news, the FDA in 2013 cleared Mega Electronics' eMotion ECG monitor to work with Android-based smartphones.
The eMotion ECG monitor leverages wireless electrodes that communicate via Bluetooth with a smartphone app. In addition, a GPS system can alert emergency services of a patient's location in case of emergency and the software has the flexibility to incorporate Bluetooth-based blood pressure and weight monitoring.
What differentiates the eMotion ECG monitor from AliveCor's smartphone ECG monitor, for instance, is that unlike the Mega Electronics system, the AliveCor device is not designed for continuous monitoring.
The FDA announced that it approved the expanded use of the Dexcom G4 Platinum continuous monitoring system for patients with diabetes ages 2 to 17 years. The G4 Platinum System, which monitors blood glucose levels in people with diabetes, had been approved for patients ages 18 and older.
To learn more:
- read the article in MD+DI