FDA To Regulate Mobile Medical Software
The regulatory status of medical apps, i.e mobile medical software, has been in limbo for some time now while observers have been watching the FDA for clues as to what role it will play. Clearly, some apps do play a role in guiding physicians in making diagnoses or making treatment decisions. Others simply provide information that would otherwise be available in textbooks or online.
What the FDA will consider a medical device or not has been an important topic, with many clues that it will consider its provenance broadly, as we have reported previously. As of now, only a few medical apps have been granted FDA approval, including AirStrip and MobileMIM.
According to the medical device consulting firm Emergo, the FDA said conclusively that they will be starting regulatory review of medical apps starting in 2011 at the recent FDA townhall meeting on March 10: Read more »
*This blog post was originally published at iMedicalApps*
A team of biomedical engineering masters students at Johns Hopkins have developed a device that they hope will be able to spot oncoming pre-term labor in pregnant women earlier than by using an external tocodynamometer.
