In late June, Glaukos announced that its iStent Inject Trabecular Micro-Bypass System received FDA approval. Glaukos says that the iStent Inject is indicated for the reduction of intraocular pressure in adult mild-to-moderate primary open-angle glaucoma patients who are undergoing concomitant cataract surgery.
|The iStent allows for the injection of two stents through a single corneal entry point.|
The iStent Inject creates two patent bypasses through the trabecular meshwork, resulting in a multi-directional flow through Schlemm’s canal. It includes two heparin-coated titanium stents preloaded into an auto-injection system that allows surgeons to precisely implant stents into two meshwork locations through a single corneal entry point, Glaukos says. Each iStent Inject stent is 0.23 x 0.36 mm.
For more information on Glaukos’ iStent Inject, visit glaukos.com.
FDA Approval for Nexy Robotic Retinal Imaging
In mid-June, the FDA approved the new Nexy retinal camera for sale in the United States. Nexy is being used in Europe for diabetic eye-screening and other healthcare initiatives to provide access to care in minimally served locations, through an optional service in which an expert can read securely distributed images.
This form of telemedicine may also be used to integrate with artificial intelligence to extract additional information from the captured images.
Nexy is developed and manufactured by Next Sight (Prodenone, Italy), and is distributed in the United States exclusively by Konan Medical. Nexy offers hands-off operation as well as features designed to integrate telemedicine and AI applications.
For more information on Nexy, visit nextsight.info.
Onefit Scleral Lens Cleared For Dry Eye
Blanchard Contact Lenses recently announced that its Onefit family of scleral lenses now has clearance from the FDA for therapeutic applications, including the treatment of dry eye, contingent on the use of the Optimum Extra, Optimum Extreme or Hexa 100 materials from lens-material maker Contamac.
Blanchard says that the FDA clearance marks an advancement in the treatment of patients suffering from ocular surface conditions such as dry eye, Sjögren’s syndrome, graft-versus-host disease, keratitis and more.
For more information regarding Onefit’s scleral lenses, visit blanchardlab.com.