Glaukos this week announced it received FDA 510(k) clearance for its iStent Infinite trabecular micro-bypass system. The FDA clearance indication is for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients who have primary open-angle glaucoma. San Clemente, California-based Glaukos designed iStent Infinite … [Read more...] about FDA clears Glaukos’ iStent Infinite
Glaukos
Glaukos submits supplemental PMA application for iStent Infinite
Glaukos (NYSE:GKOS) announced today that it submitted a supplemental premarket approval application to the FDA for its iStent Infinite system. San Clemente, California–based Glaukos designed the iStent Infinite trabecular micro-bypass system for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with … [Read more...] about Glaukos submits supplemental PMA application for iStent Infinite
The 18 most innovative medical devices of 2021
The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards. The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition. “The Awards Committee is excited to … [Read more...] about The 18 most innovative medical devices of 2021
Glaukos wins Australian regulatory approval for MicroShunt
Glaukos (NYSE:GKOS) recently announced that it received regulatory approval from Australia's Therapeutic Goods Administration for its Preserflo MicroShunt. The San Clemente, Calif.–based company designed the MicroShunt to reduce intraocular pressure in the eyes of patients who have primary open-angle glaucoma where IOP remains uncontrollable or … [Read more...] about Glaukos wins Australian regulatory approval for MicroShunt