In 2019, Roche-owned Genentech acquired the assets of Vital Art and Science, developers of an FDA-cleared digital device called myVisionTrack. Genentech has been relatively quiet about myVisionTrack since then but this week it noted that myVisionTrack is now FDA-registered as a SaMD.
The FDA's database shows that myVisionTrack is registered as a Class 1 device. Previous versions of the device have been registered as a Class 1 device since 2013 but this new iteration uses BrightInsight's platform to power it.
While myVisionTrack is owned by Roche, Roche's partner BrightInsight is listed in the FDA's database as the manufacturer.
myVisionTrack provides a vision test that allows patients with retinal diseases to self-track changes in their vision and automatically alerts one’s physician if a patient’s sight starts to deteriorate.