Showing 1271-1280 of 1484 results for "".
- Luminopia Announces FDA Approval of Digital Therapeutic to Improve Vision in Children with Lazy Eyehttps://modernod.com/news/luminopia-announces-fda-approval-of-digital-therapeutic-to-improve-vision-in-children-with-lazy-eye/2480369/Luminopia announced that the FDA has granted de novo premarket approval for Luminopia One as a prescription therapy to improve vision in children with amblyopia (lazy eye), the leading cause of vision loss in children. Luminopia One is indicated for improvement in visual acuity in child
- Pfizer, BioNTech’s COVID-19 Vaccine on Brink of Full FDA Approvalhttps://modernod.com/news/pfizer-biontechs-covid-19-vaccine-on-brink-of-full-fda-approval/2479464/According to people familiar with the matter, the FDA is expected to grant full approval to Pfizer and BioNTech’s COVID-19 vaccine BNT162b2 as soon as Monday, The New York Times reported. The sources suggested that the agency was aiming to complete the process by August 20, but was still wo
- iSTAR Medical Receives FDA Approval to Begin Trial for MINIject for Patients With Glaucomahttps://modernod.com/news/istar-medical-receives-fda-approval-to-begin-trial-for-miniject-for-patients-with-glaucoma/2479375/iSTAR Medical announced that the FDA granted it investigational device exemption (IDE) to start a trial with MINIject. The STAR-V study will investigate MINIject in over 350 patients with primary open-angle glaucoma. Glaucoma surgeons in the United States, Canada, and Europe will join the trial.<
- Glaukos Announces Australia’s TGA Regulatory Approval for Preserflo MicroShunthttps://modernod.com/news/glaukos-announces-australias-tga-regulatory-approval-for-preserflo-microshunt/2479276/Glaukos Corporation announced that the Therapeutic Goods Administration (TGA) of Australia has granted regulatory approval for the Preserflo MicroShunt intended for the reduction of IOP in eyes of patients with primary open-angle glaucoma where IOP remains uncontrollable while on maximum tolerate
- Essilor Receives FDA Breakthrough Device Designation for Essilor Stellest Spectacle Lenshttps://modernod.com/news/essilor-receives-fda-breakthrough-device-designation-for-essilor-stellest-specticle-lens/2479220/Essilor announced that the FDA has granted Breakthrough Device designation to its Essilor Stellest spectacle lens, the company’s new generation lens developed to correct myopia and slow down the progression of myopia in children. The designation of the Essilor’s Stellest spectacle lens as
- FDA Authorizes Pfizer, BioNTech’s COVID-19 Vaccine for Younger Adolescentshttps://modernod.com/news/fda-authorizes-pfizer-biontechs-covid-19-vaccine-for-younger-adolescents/2479191/The FDA on Monday expanded the emergency-use authorization (EUA) for Pfizer and BioNTech’s vaccine BNT162b2 to include preventing COVID-19 in adolescents 12 through 15 years of age, according to a FirstWord report. The two-dose mRNA-based vaccine was initially granted an EUA in December for
- Rayner’s RayOne Aspheric preloaded IOL launches in Chinahttps://modernod.com/news/rayners-rayone-aspheric-preloaded-iol-launches-in-china/2479183/Rayner announced that its RayOne Aspheric fully preloaded IOL injection system has been approved by the Chinese regulator, National Medical Products Administration (NMPA), and is now available for commercial use in China. The NMPA granted regulatory approval and sale of the 6.0 mm RayOne A
- Ceyeber Announces Advisory Board of World-Renowned Ophthalmologistshttps://modernod.com/news/ceyeber-announces-advisory-board-of-world-renowned-ophthalmologists/2479167/Ceyeber, the developer of implantable intraocular lens technology designed for medical applications and augmented reality, has created a Medical Advisory Board consisting of top ophthalmologists. Ceyeber’s founder and CEO, Robert E. Grant, said, “
- Lumenis Receives FDA Approval for Its IPL Device to Manage Dry Eye Disease and Launches OptiLighthttps://modernod.com/news/lumenis-receives-fda-approval-for-its-ipl-device-to-manage-dry-eye-disease-and-launches-optilight/2479143/Lumenis announced that the FDA has granted De Novo authorization for Lumenis’ newest intense pulsed light (IPL) device for improving signs of dry eye disease due to meibomian gland dysfunction (MGD). The Lumenis multicenter, double-blinded, randomized controlled FDA trial showed that
- Glaukos Announces Global Licensing Agreement Amendment with Intratus to Include the Treatment of Presbyopiahttps://modernod.com/news/glaukos-announces-global-licensing-agreement-amendment-with-intratus-to-include-the-treatment-of-presbyopia/2479115/Glaukos announced that it has entered into an amended licensing agreement with Intratus under which Intratus has granted Glaukos a global exclusive license to research, develop, manufacture and commercialize Intratus’ patented, noninvasive drug delivery platform (the Eyelid Drug Delivery Platform