First FDA-cleared Home Monitor for Macular Degeneration

July 2, 2014

A revolutionary home monitoring system from the Israeli company Notal Vision keeps a daily eye on the progression of age-related macular degeneration (AMD), the Western world’s leading cause of vision loss. Monitoring is critical, as AMD can suddenly advance from the common “dry” form—where the light-sensitive cells of the eye’s macula slowly break down—to the serious “wet” form that accounts for 90 percent of legal blindness. There is no intermediate stage of wet AMD, nor is there an effective medical treatment for dry AMD.

Notal Vision’s ForeseeHome is the first FDA-cleared home monitoring device clinically proven to detect the slightest changes in vision and is available by prescription on a rental basis throughout the United States.

If a change above the patient’s baseline is detected via computer analysis of the three-minute screening, Notal’s call center in St. Louis contacts the physician. Cofounder Dr. Barak Azmon says the device is already used by thousands of patients.

But now it’s really become the talk of the town (or the globe, to be more precise) because of recently published results of an unusually large US clinical study on the efficacy of the device.

“At the end of 2009, we had done some small clinical trials and got FDA approval, and then the NIH [National Institutes of Health] approached us to evaluate our solution through a multicenter longitudinal trial,” Azmon tells ISRAEL21c. (Read More)

Source: By Abigail Klein Leichman, ISRAEL21c, excerpts of article reprinted with permission.