Settlement Holds Telehealth Company Accountable for Ignoring FDA Requirements, Misleading Patients

Attorney General Michelle Henry announced a bipartisan national settlement that holds an online telehealth company responsible for misrepresenting the accuracy and fairness of services, and for failing to obtain approvals from the US Food and Drug Administration (FDA). The settlement, an Assurance of Voluntary Compliance (AVC), results from an investigation into deceptive business practices by Visibly, Inc. — formerly known as Opternative Inc. The company markets and sells an online vision test, among other products. The multistate investigation was opened after a letter from the FDA warned Visibly about marketing its online vision tests without the requisite clearance or approval. The investigation also raised concerns about Visibly’s claims regarding accuracy and safety of its online test, specifically, that the tests were as accurate as in-person exams. Additionally, the investigation examined Visibly’s misrepresentations about customer satisfaction rates and satisfaction guarantees.

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