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Home AMD monitor receives 510(k) clearance from FDA

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ST. LOUIS — Notal Vision's ForeseeHome age-related macular degeneration monitor has received 510(k) clearance from the U.S. Food and Drug Administration, the company announced in a press release.

The ForeseeHome AMD monitor is the first home device cleared by the FDA for the ongoing monitoring of wet AMD. It is capable of transferring eye exam data to the patient's eye care physician as well as to the Notal Vision Data Monitoring Center, the release said.

While the ForeseeHome is intended for use in detecting visual distortion and monitoring the progression of disease factors such as choroidal neovascularization in patients with AMD, the device is not indicated as a diagnostic tool and is ineffective among patients who have unstable fixation, according to company literature.