Notal Vision has received Section 510 (k) clearance from the FDA for its ForeseeHome AMD Monitor, a home solution for frequent, ongoing monitoring of age-related macular degeneration.
The company claims that ForeseeHome is the first ophthalmic device linking patients and doctors between eye exams for ongoing monitoring of AMD. Patients complete a frequent but brief exam on their ForeseeHome AMD Monitor at home, and data is transmitted to the patients’ eye care physician and the Notal Vision Data Monitoring Center.
The design of the new AMD Monitor is easy to use for patients at risk of vision loss from wet AMD. Wet AMD is the cause of blindness in people over the age of 60 in the western world. Recent breakthroughs in treatments place even greater importance on early detection, which can reduce the risks of vision loss associated with wet AMD.
Frequent monitoring is critical in detecting disease onset as early as possible and ForeseeHome is a home monitoring device for following patients at risk of vision loss. ForeseeHome has undergone numerous clinical studies demonstrating its application in frequent monitoring of patients at risk for vision loss from wet AMD, said the company.