More News
Want to Read Locked Articles?
Already Have an Account?
Register A Corporate Account
A corporate account gives you access to licensed reports and subscriptions, the latest news, a personalized dashboard, and weekly emails with news and data.
Select US FDA Approvals and Clearances in April 2023
Author: Kristen Harmon Ingenito, MBA
The US FDA granted two clearances through the ophthalmic device division using the 510(k) pathway in April 2024, according to the agency’s database. Topcon received 510(k) clearance for its Maestro2 OCT, which now includes linkage with newer ImageNet6 image management software and has optional remote operation functionality. Newcomer Aeye Health gained clearance for its AI software to detect more-than-mild diabetic retinopathy. The software is now indicated for use with the Optomed Aurora han...
