FDA LOOKING TO REGULATE MEDICAL APPS

The U.S. Food and Drug Administration may soon approve or reject mobile health applications. The government agency said on Wednesday that it is proposing to oversee the applications in an effort to ensure the apps perform as advertised and aren’t actually hurting users. “There are advantages to using medical apps, but consumers and health care professionals should have a balanced awareness of the benefits and risks,” FDA policy advisor Bakul Patel said. The administration hopes to approve and reject mobile applications that:

• Are used as an accessory to an FDA-regulated medical device. For example, an app could enable a health care professional to view medical images on an iPad and make a diagnosis;
• Transform a mobile platform into a regulated medical device. For example, an app that turns a smartphone into an electrocardiography, or ECG, machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

“We want to hear from as many consumers, advocacy groups, health care professionals, and software creators and distributors as possible to help us finalize the proposed guidelines,” Patel said. The proposed guidelines will be published on Wednesday.

NEW BRAIN CONTROLLED ROBOTIC ARM PROSTHETIC HITS FDA

The FDA has just announced a new "Innovation Pathway" program that promises to allow for priority reviews of "truly pioneering technologies," which could potentially cut the approval process time in half. Somewhat ironically, however, that program itself will first need some further review before it's broadly deployed, but the FDA has already kicked things off on a limited basis with its first submission: a brain-controlled robotic arm from DARPA. It's not clear which arm that is, but it sounds a lot like the now-famous "Luke" arm (pictured above) developed by Dean Kamen's Deka organization, which just so happens to be funded by DARPA