Intel-GE gets FDA approval for Intel Health Guide

Intel-GE Care Innovations, a joint venture of Intel and GE, has received U.S. Food and Drug Administration 510(k) clearance for the Intel Health Guide Express. This is a software solution that combines in-home monitoring, patient education, and online provider consultation capabilities to improve chronic disease management.

The current Intel Health Guide is a video kiosk that connects patients with caregivers. The new version of the system can run on personal computers, making it easier for consumers to use. A commercial version of this system is expected by the end of the second quarter.

According to GE-Intel, the Intel Health Guide Express will be able to collect and transmit a patient's vital signs from home monitoring devices. Additionally, it can be used for interactive patient health sessions, video conferencing, and accessing multimedia educational content on consumer PCs.

The system combines an in-home patient device with the Intel Health Care Management Suite, an online interface that allows clinicians to monitor patients and remotely manage care. The in-home patient device can connect to specific models of wired and wireless medical devices, including blood pressure monitors, glucose meters, pulse oximeters, peak flow meters and weight scales. It stores and displays the collected information for the patient and sends it to a secure host server, where healthcare professionals can review the information.

The FDA recently relaxed its requirements for approval of data systems that are used to display, transfer or store medical device information. One example is devices that store or transmit data from a glucose meter. These systems are now classified as Class I, "low-risk" devices that don't require premarket approval, although they must adhere to quality standards. Previously, they were categorized in Class III, which does require prior approval, and that's what the Intel Health Guide has just received.

To learn more:
- read the GE-Intel press release
- see the Government Health IT story on the FDA rule change
- see the Health Data Management article 


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