Wednesday, December 12, 2012

Companies Receive FDA Clearance

At the mHealth Summit, AliveCor, Inc announced that the company received FDA 510(k) clearance on their mobile Heart Monitor as well as CE Mark conformity. This clinical-quality, low-cost mobile ECG heart monitor, compatible with the iPhone 4 and 4S, enables doctors to evaluate patient heart health easily, quickly, and remotely.

Clinical studies of the device indicate that a high quality single-channel ECG can be rapidly and simply recorded using an iPhone with the AliveCor application and device to accurately screen for cardiac arrhythmias including atrial fibrillation.

Additionally, AliveCor’s founder Dr. David Albert along with co-founders Bruce Satchwell and Kim Barnett were granted U.S. Patent No. 8,301,232 for the device and technology. The three colleagues began working on the heart monitoring device in 2008.

The Heart Monitor is available for pre-sale to medical professionals in the U.S. through the company website at

In November, AFrame Digital received FDA 510(k) clearance to market its MobileCare Monitor system as a Class II device. The device has been cleared as a Class I device since 2009. The MobileCare Monitor services offer a scalable, hosted platform for care professionals to support patients across the continuum of care.

Someone wearing AFrame Digital’s wireless wristwatch-based health monitor can press a button to request help. Also, if that person experiences a fall or has vital sign reading outside their personal baseline or target range, the system will generate an alert in real-time to caregivers through their mobile communications device of choice.

The monitoring device offers a patented method for non-intrusively and continuously gathering data about a person’s activity when combined with vital signs and gait data to create individualized baselines of wellness. Vital sign data is obtained wirelessly from Class II FDA cleared devices such as Bluetooth-enabled glucometers, pulse oximeters, weight scales, and blood pressure cuffs.

For more information, go to