Medical App Or Medical Device?

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RENO, NV - About 2 years ago, St. Mary's Regional Medical Center implemented a new monitoring system in its labor and delivery department called Airstrip O-B. Hooked to a physician's mobile phone, it delivered patient information in real time.

At the time Dr. Ricardo Garcia was skeptical.

“When I first got it, I said, I'm never going to use that,” said Dr. Garcia.

But Dr. Garcia says he soon changed his mind.

He says he didn't have to wait for a call from the hospital, and discussions with staff; instead he said he could just head down the the hospital.

The monitor at the pregnant woman's beside and at the nurses station was regulated by the F-D-A, and within the year the mobile device received the same standing.

But that's not always the case.

That will change, though, as the F-D-A looks at a handful of Apps that turn the mobile phone into a medical device and could be harmful if they don't work as promised.

The federal agency says Apps that monitor a person's caloric intake or are used as a quick medical reference probably won't fall under more stringent regulations.

But those that monitor perinatal activity, Apps that monitor heart beats, or have smartphone attachments, could be treated as a medical device and fall under stricter regulations.

Right now the agency is working on educating App designers and developers to help them understand who does and doesn't have a medical device on their hands.

So far, the FDA has cleared more than 100 mobile Apps which include blood pressure monitors and real-time electrocardiograms to your doctor.

But the FDA wants consumers to know medical Apps should be used in conjunction with working with your doctor, not in lieu of it .


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