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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Contacts
Michael Egleston
info@diopsys.com