Category Archives: Healthcare IT

Healthcare Information Technology

General Wellness: Policy for Low Risk Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “General Wellness: Policy for Low Risk Devices.” FDA is issuing this draft guidance to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health’s (CDRH’s) compliance policy for low risk products that promote a healthy lifestyle (general wellness products). This draft guidance is not final nor is it in effect at this time.

FDA Register

DRAFT Policy

 

How Clear Is The Future Of Google Glass?

There is no question that the wearables market is taking off with the proliferation of health monitors, pedometers and activity trackers like Fitbit, Jawbone, Nike Fuelband, etc. And next year the Apple Watch will likely make the wearable watch the next big thing. Gartner boldly predicted that companies using Glass and similar wearable gadgets could save up to $1 billion a year within the next three to five years.

Techcrunch