Avisi Technologies’ investigational device exemption for VisiPlate approved by FDA
Oct, 2025
News
Key Takeaways
- VisiPlate’s IDE approval allows clinical studies in the US, focusing on safety and effectiveness data collection for the novel glaucoma treatment device.
- The device’s unique metamaterial and multichannel design aim to reduce IOP and minimize blockage risks, offering potential advantages over current surgical treatments.
- VITA trial results demonstrated a 40.4% mean IOP reduction and decreased medication use, with a significant portion of patients achieving substantial IOP control.
- The IDE approval represents a significant milestone for Avisi Technologies, enabling further investigation of VisiPlate’s potential benefits for glaucoma patients in the US.
Avisi Technologies’ investigational device exemption (IDE) submission for its glaucoma treatment device VisiPlate has been approved by the US Food and Drug Administration (FDA).1
As defined by the FDA, an IDE allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Additionally, an approved IDE permits a device to be “shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (FD&C Act) that would apply to devices in commercial distribution.”2
Share this article:
