Dow Jones reported last week the U.S. Food and Drug Administration is planning to regulate mobile medical applications that would be used in the practice of medicine such as apps that display x-rays or allow a phone or computer to be used as a sensor to detect abnormal heart rhythms.
The agency said it won't regulate other medical apps that provide medical advice or count calories, for example.
Bakul Patel, policy advisor in FDA's device division, said the agency is proposing to regulate a small subset of health-related applications that can be downloaded to various smart phones and tablets. He explained the apps the FDA would regulate are things that doctors would use to diagnose or monitor a medical condition.
He said the agency would focus on apps that could present a risk to patients if the apps don't work as intended. The guidelines are posted online and are open for a 90-day comment period.
In February, the FDA cleared a mobile radiology application to allow physicians to view medical images on Apple Inc.'s (AAPL) iPhone and iPad. The application allows doctors to view various scans including computed tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET).
Patel said the agency has also recently cleared an ultrasound application.
No comments:
Post a Comment