iPhone App for Vision Tests Gains FDA Approval
"For new tests such as ours, the FDA has made it clear they want to see our test results on each new platform and approve those one by one," Bartlett said. "The big challenge in developing a medical app for Android is that not only are the screen sizes different but every manufacturer customizes the Android operating system as well," he explained. "This makes developing apps like ours very challenging, and by the time we get through the verification and validation testing and then the FDA approval, the smartphone is obsolete," Bartlett said. Many "serious" medical apps are developed for Apple iOS because of the "relative stability to the hardware and operating system," Bartlett said. In studies conducted using the MyVisionTrack app, tests resulted in sensitivity and specificity that were either higher than or comparable to clinical tests, VAS reported. The app can be used inside or outside a doctor's office. The National Eye Institute, a division of the National Institutes of Health performed a "proof of concept" study on the app in 2010 at the University of Texas Southwestern Medical Center and Retina Foundation of the Southwest, Bartlett noted.A 2011 study by a major drug company on 160 wet, age-related macular degeneration (AMD) patients revealed the results of MyVisionTrack matched up well with visual acuity testing by a doctor, Bartlett said. MyVisionTrack stores the results on the iPhone locally and encrypts test results using an algorithm compliant with the Health Insurance Portability and Accountability Act (HIPAA). Although MyVisionTrack isn't available for download yet from iTunes, a doctor may distribute iPhones with the software already installed. The company is looking to distribute the app commercially and has not set pricing for the product, according to Mobihealthnews. VAS is working with Novartis, which offers the wet AMD drug Lucentis and funded a clinical trial for the app. "Our goal is to collaborate with the drug companies producing the therapies for these retinal diseases to quickly deploy our test out to their patients," Bartlett said. Drugs such as Lucentis "can help control the disease, but are not a cure, and so patients need a way to monitor their own disease progression at home to ensure they get timely treatments," he said. "We want to do everything we can to help those suffering from one of these diseases to save their vision."
"In this study we had 36 diabetic retinopathy patients who tested at home for six months, and it demonstrated the basic capability of patients to self-test at home with good results," he said.