The FDA has given MedApps, a Scottsdale, Arizona firm, 510(k) market clearance for the firm’s HealthPAL wireless medical device monitor. Featuring built-in mobile phone technology and the ability to connect to common at-home medical devices via a cable or wirelessly via Bluetooth, the system is designed to provide continuous uploading of patient data to a central server for analysis by clinicians.
From the product page:
HealthPAL automatically collects data from compatible, off-the-shelf, medical monitors using a smart cable or wirelessly via Bluetooth. The data is then transmitted using embedded M2M (GSM) cellular chip (and soon CDMA) technology to be received by HealthCOM, MedApps’ full-featured, web-based portal for health care providers.
About the size of a cell-phone, the HealthPAL is ultra-portable for maximum mobility and its low cost enables remote monitoring to be available to large patient populations. It is considered to be the ultimate in simplicty. While it has buttons for special features and set-up, during daily operation the reading and data transmissions are COMPLETELY automated. The patient does not push any buttons, navigate any screen commands or touch the HealthPAL in any fashion.
HealthPAL is currently approved for use in conjunction with glucose meters, blood pressure monitors, weight scales, pulse oximeters and pedometers. As additional approvals are received, MedApps looks forward to expanding its capabilities to include the recording and transmitting of data from INR monitors, ECG, Peak Flow, CPAP, spirometers, O2 concentrators and more.
Press release: MedApps Receives FDA Clearance on a New Way to Bring Cost-Effective Remote Health Monitoring to More People…
Product page: HealthPAL…