Category: Cardiac Designs
New mobile phone devices win 510(k) clearance, adding to the growing market for patient self-monitoring devices
A growing demand for mobile health monitoring devices led to a boom in mobile devices that allow patients to manage chronic illnesses and measure body metrics at home. Now, several companies have won FDA clearance for next-generation health monitoring devices that connect wirelessly to mobile apps and software.
Palo Alto, Calif.-based Glooko will begin selling its second glucose monitoring app and cable device. This product comes with enhanced software that allows patients to program health goals and enhanced data security through advanced encryption.
California mobile medical device maker AliveCor releases a new model of its ECG monitoring and recording technology to fit the size and shape of the iPhone 5 and plans to hand out free samples at the Heart Rhythm Society meeting in Denver, Colo.
California startup AliveCor updated its heart monitor to make it compatible with the next-generation iPhone 5. The company's mobile ECG snaps on to the outside of an iPhone with sensors that monitor and record electrocardiogram rhythms wirelessly.
Utah medical device startup Cardiac Designs wins over-the-counter indication for its iPhone-based ECG monitor.
Utah-based Cardiac Designs is still flying under the radar after having won FDA 510(k) clearance for its iPhone-based ECG monitor.
The FDA nod may represent a win for consumers who are increasingly interested in recording their own health data, but the regulatory win comes with a strange restriction - patients must obtain a physician prescription in order to view the raw wave form data captured from the heart.