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Diopsys, Inc. Announces Settlement with the Department of Justice

Diopsys, Inc. has settled all claims with the Department of Justice related to its Nova ERG device marketing activities from the period of 2015-2021. The settlement provides for a series of guaranteed payments totaling $1,225,000 and contingent payments up to a maximum of $13,025,000 to be made over a period of 6 years.

“We take regulatory requirements seriously and this agreement reinforces that commitment,” stated Michael Egleston, CFO, Diopsys, Inc. “With the settlement now complete, Diopsys can proceed with submitting a new 510K application to the FDA for its redesigned ERG device and working to restore its ERG presence in the US marketplace.”

About Diopsys, Inc.

Diopsys, Inc. is a medical device company commercializing the NOVA™ Vision Testing System. NOVA is a comprehensive electrophysiology platform that provides objective assessment of the entire pathway for visual and neuro-visual disorders. VEP is available in the USA and select countries outside of the USA. ERG is only available outside of the USA.

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