Showing 661-670 of 1161 results for "".
- Lensar Submits FDA 510(k) Application for ALLYhttps://modernod.com/news/lensar-announces-us-food-and-drug-administration-acceptance-of-510k-submission-for-ally/2480671/Lensar announced that the FDA has accepted its 510(k) submission for its next-generation ALLY Adaptive Cataract Treatment System for review. The submission is the first stage of a planned, two-step commercial release s
- Ocuphire Pharma Appoints Joseph K. Schachle COOhttps://modernod.com/news/ocuphire-pharma-reports-inducement-grant-for-new-coo/2481985/Ocuphire Pharma announced that the independent members of its Board of Directors approved an equity award under the company’s 2021 Inducement Plan as a material inducement to Joseph K. Schachle in connection with his employment with Ocuphire effective on November 27, 2023. The equity award
- Oertli Receives FDA 510(k) Clearance for Faros Surgical Systemhttps://modernod.com/news/oertli-instrumente-ag-achieves-milestone-with-fda-510k-clearance-for-faros-surgical-system/2482371/Oertli Instrumente announced it has received FDA 510(k) clearance for the Faros anterior cataract surgery system. According to a company news release, the Faros system offers a compact design and rapid operational readiness, requiring minimal space in operating rooms. It
- Glaukos Receives FDA 510(k) Clearance of the iStent Infinitehttps://modernod.com/news/glaukos-receives-fda-510k-clearance-for-the-istent-infinite/2481013/Glaukos announced that it has received 510(k) clearance from the FDA for the iStent infinite Trabecular Micro-Bypass System. The iStent infinite is indicated for use in a standalone procedure to reduce elevated IOP in patients with primary open-angle glaucoma uncontrolled
- DORC Obtains FDA 510(k) Clearance for Eva Nexus Systemhttps://modernod.com/news/dorc-obtains-fda-510k-clearance-for-eva-nexus-system/2480959/DORC International has announced 510(k) market clearance and the launch of the Eva Nexus. According to DORC, the Eva Nexus features multiple innovations to improve performance, efficiency, and stability for retina surgeons, including Smart IOP for anterior
- Glaukos Announces FDA 510(k) Clearance of iPRIME Viscodelivery Systemhttps://modernod.com/news/glaukos-announces-fda-510k-clearance-of-iprime-viscodelivery-system/2480553/Glaukos announced that it has received 510(k) clearance from the FDA for the iPRIME Viscodelivery System, a sterile, single-use, minimally-invasive device for the delivery of viscoelastic fluid during ophthalmic surgery. “Since the introduction of our first&nb
- Euclid Systems Launches New Euclid MAX Ortho-K Lenshttps://modernod.com/news/euclid-systems-launches-new-euclid-max-ortho-k-lens/2479200/Euclid Systems announced the United States launch of the overnight orthokeratology lens Euclid MAX. Used in children and adult patients with progressive myopia, but especially children, Ortho-K contact lenses gently reshape the cornea to manage myopia while the patient sleeps. “Euclid MAX
- Vasoptic Medical Receives FDA 510(k) Clearance for Retinal Imaging Devicehttps://modernod.com/news/vasoptic-medical-receives-fda-510k-clearance-for-retinal-imaging-device/2477882/Vasoptic Medical has received 510(k) clearance from the FDA for its XyCAM RI noninvasive retinal imager. The XyCAM RI provides dynamic and quantifiable blood flow measurement synchronized with finger pulse oximeter data. The device
- RightEye Eye-Tracking System Receives FDA 510(k) Clearancehttps://modernod.com/news/righteye-eye-tracking-system-receives-fda-510k-clearance/2479799/RightEye announced that the company’s vision system has received 510(k) clearance from the FDA. The system records, views, and analyzes eye movements in support of identifying visual tracking impairment in patients. Using advanced eye-tracking technology and analytics, the RightEye s
- iCare USA Receives FDA 510(k) Clearance for Eidon Ultra-Widefield Lens Modulehttps://modernod.com/news/icare-usa-presents-ultra-widefield-imaging-for-the-eidon-diagnostics-platform/2480330/iCare USA has received FDA 510 (k) clearance for the Eidon Ultra-Widefield Lens module.&