Showing 871-880 of 1161 results for "".
- Glaukos Announces Positive Phase 3 Trial Results for iLink Epi-On Investigational Therapyhttps://modernod.com/news/glaukos-announces-positive-phase-3-trial-results-for-ilink-epi-on-investigational-therapy/2478917/Glaukos announced that U.S. phase 3 pivotal trial results for its next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, known as Epi-on, met the study’s primary efficacy endpoint, demonstrating a statistically significant improvement in maximum corneal curvature (K
- Norlase Announces FDA Clearance and US Launch of New LION Laser Systemhttps://modernod.com/news/norlase-announces-fda-clearance-and-u-s-launch-of-new-lion-laser-system/2478470/Norlase announced the 510(k) clearance from the FDA and the immediate commercial launch of Norlase LION, a green laser photocoagulator fully-integrated into a Keeler indirect ophthalmoscope. Unlike other laser indirect ophthalmoscopes that require a fiber optic connection to a laser source
- Blanchard Contact Lenses Adds Paragon CRT to Product Portfoliohttps://modernod.com/news/blanchard-contact-lenses-adds-paragon-crt-to-product-portfolio/2478464/Blanchard Contact Lenses announced that it has expanded its product portfolio in the United States to include Paragon CRT and Paragon CRT Dual Axis ortho-k lenses. Paragon CRT and Paragon CRT Dual Axis are reverse geometry corneal lenses manufactured in high-Dk gas permeable lens material
- Aviceda Therapeutics Appoints Biopharma and Business Veterans to its Board of Directorshttps://modernod.com/news/aviceda-therapeutics-appoints-biopharma-and-business-veterans-to-its-board-of-directors/2478284/Aviceda Therapeutics has announce the appointment of Chris Adams, PhD, MBA, and Nancy K. Thomason, MBA, to their board of directors, effective immediately. Aviceda is a preclinical stage biotech company focused on the next generation of glyco-immune therapeutics utilizing the Glyco-Code technolog
- Gyroscope Therapeutics Announces FDA Clearance of Orbit Subretinal Delivery Systemhttps://modernod.com/news/gyroscope-therapeutics-announces-fda-clearance-for-orbit-subretinal-delivery-system/2478198/Gyroscope Therapeutics announced that the FDA has granted 510(k) clearance for the Orbit Subretinal Delivery System (Orbit SDS). The Orbit SDS is indicated for microinjection into the subretinal space at the back of the eye. The microinjection procedure is designed to avoid damaging the structure
- Eyenuk Announces FDA Clearance for EyeArt Autonomous AI System for Diabetic Retinopathy Screeninghttps://modernod.com/news/eyenuk-announces-fda-clearance-for-eyeart-autonomous-ai-system-for-diabetic-retinopathy-screening/2478123/Eyenuk announced it has received 510(k) clearance by the FDA to market its EyeArt autonomous AI System for diabetic retinopathy. EyeArt is indicated for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopa
- Norlase Announces CE Mark Approval for LEAF Green Laserhttps://modernod.com/news/norlase-announces-ce-mark-approval-for-leaf-green-laser/2478045/Norlase announced that it has been granted the CE Mark approval for the LEAF, a first in class, fiberless green laser for the treatment of retina and glaucoma diseases. The CE Mark follows the recent FDA 510(k) market clearance of the LEAF and ISO 13485:2016 certification of Norlase’s medical dev
- Johnson & Johnson Vision Receives FDA Clearance for Catalys cOS 6.0 Software for Astigmatism Managementhttps://modernod.com/news/johnson-johnson-vision-recevies-fda-clearance-for-catalys-cos-6-0-software-for-astigmatism-management/2477915/The FDA has granted 510(k) clearance for new software for the Catalys Precision Laser System that aims to simplify astigmatism management workflow and increase operational efficiency. The Catalys cOS 6.0 software with advanced astigmatism management is a collaboration with Cassini Technolog
- Bausch + Lomb Receives FDA Clearance for Infuse Daily Disposable Silicone Hydrogel Contact Lenseshttps://modernod.com/news/bausch-lombs-infuse-daily-disposable-silicone-hydrogel-contact-lenses-receive-fda-510k-clearance-for/2477862/Bausch + Lomb has received 510(k) clearance from the FDA for the Bausch + Lomb Infuse daily disposable silicone hydrogel (SiHy daily) contact lenses. Bausch + Lomb Infuse contact lenses feature a next generation contact lens material (kalifilcon A), which is designed to meet the unmet need
- Inovio Hints at Positive Early Phase 1 Safety Data for COVID-19 Vaccine INO-4800https://modernod.com/news/inovio-hints-at-positive-early-phase-1-safety-data-for-covid-19-vaccine-ino-4800/2477810/Inovio Pharmaceuticals suggested that preliminary safety data from an ongoing phase 1 trial indicates that its experimental COVID-19 DNA vaccine candidate INO-4800 appears to be safe in humans. “We are already seeing safety data and it has been benign,” commented R&D head K