high-risk medical devices

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Health IT tools lack proof of effectiveness

Katie Dvorak | Fierce Health IT | August 31, 2015

There are myriad apps, tools and technologies entering the healthcare marketplace--but most lack proof that they are helping consumers battle disease and stay healthy, according to an article in Fortune. To that end, hospitals must be very careful when adopting health IT, according to Richard Milani, chief clinical transformation officer at Ochsner Health System. "You want to be comfortable that the technology you're utilizing is reliable and accurate," Milani tells Fortune. "That's a genuine concern. If you have some scientific data or peer-reviewed data to back it up, that certainly makes it a little easier."

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Too little research backs high-risk medical devices

Susan D. Hall | Fierce Health IT | August 12, 2015

The U.S. Food and Drug Administration's Premarket Approval pathway allows high-risk medical devices on the market with only one study to prove their safety and effectiveness, and there are a limited number of studies done post-market, according to research published in Journal of the American Medical Association. Medical device regulation in the U.S. is more rigorous than in other parts of the world, but "the difference is, in many European countries they have much better capacity to follow devices once they are in practice," senior author Joseph S. Ross, M.D., of the Yale University School of Medicine, told Reuters.

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