FDA recently granted clearance to a new telemedicine product – the Welch Allyn iExaminer – which, when used in conjunction with the iPhone, allows users to capture, send, store, and receive high resolution images of the eye. According to the manufacturer’s 510(k) submission, the iExaminer is cleared for prescription use only and is intended to be used by trained personnel in a medical or school environment. Health professionals may use the images to assist in various ways, including assisting with diagnosis of eye conditions, sending the images to specialists, or saving the images as part of the medical record for future comparisons.
The iExaminer is not the first iPhone app to receive medical device clearance, which FDA is limiting to those applications that meet the definition of “medical device”. FDA previously cleared apps intended for use by medical professionals and consumers to measure blood pressure, view radiological images, and monitor blood glucose. FDA has expressed support for the benefits of applications in the health setting, but has cautioned that medical professionals and consumers must also be aware of the risks. In particular, the agency is concerned about apps that could pose a health risk to consumers and patients if they do not work as intended. FDA’s draft guidance for industry regarding medical mobile applications is available here.