Showing 2161-2170 of 5623 results for "".
- Nicox Announces Recruitment of Last Patient in US in Denali Phase 3 Trial of NCX 470https://modernod.com/news/nicox-announces-recruitment-of-last-patient-in-us-in-denali-phase-3-trial-of-ncx-470/2482375/Nicox announced the recruitment and randomization of the last patient in the United States in its Denali phase 3 trial of NCX 470. The Denali trial is evaluating NCX 470 safety and efficacy in patients with open-angle glaucoma or ocular hypertension. Ac
- Spryte Medical Receives Breakthrough Device Designation from FDA for Neuro OCT Technologyhttps://modernod.com/news/spryte-medical-receives-breakthrough-device-designation-from-fda-for-neuro-optical-coherence-tomography-noct-technology/2482373/Spryte Medical announced that its neuro Optical Coherence Tomography (nOCT) technology has been granted Breakthrough Device Designation by the FDA. This recognition underscores the potential of nOCT in neurointervention and cerebrovascular treatment. The FDA’s
- Osheru Secures $4.7 Million Seed Funding to Advance Ziplyft Device for Blepharoplasty Surgeryhttps://modernod.com/news/osheru-secures-47-million-seed-funding-to-advance-ziplyft-device-for-blepharoplasty-surgery/2482370/Osheru announced the completion of a $4.7 million funding round to accelerate the development and commercialization of its Ziplyft device for blepharoplasty surgery. Blepharoplasty, a procedure aimed at rejuvenating the appearance of the eyelids, remains one of the most sought-afte
- New Data for Susvimo Demonstrates Sustained Efficacy in DME and DRhttps://modernod.com/news/new-data-for-susvimo-demonstrates-sustained-efficacy-in-dme-and-dr/2482365/Genentech and Roche announced 2-year data from the phase 3 Pagoda and Pavilion studies evaluating Susvimo (ranibizumab injection) 100 mg/mL for the treatment of diabetic macular edema (DME) and diabetic retinopathy (DR), respectively. Susvimo, which is being
- CDRH Expands TAP Program to Include Ophthalmic Deviceshttps://modernod.com/news/cdrh-expands-tap-program-to-include-ophthalmic-devices/2482344/Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health (CDRH), announced the continued expansion of the Total Product Life Cycle (TPLC) Adv
- Beacon Therapeutics Raises Funds to Advance Development of Its Ophthalmic Gene Therapieshttps://modernod.com/news/beacon-therapeutics-raises-funds-to-advance-development-of-its-ophthalmic-gene-therapies/2482341/Beacon Therapeutics announced it has raised $170 million in Series B funding, which will be used to support the continued clinical development of Beacon’s lead asset, AGTC-501, for X-linked retinitis pigmentosa (XLRP; laruparetigene zovaparvovec) and generate phase 1/2 clinical trial d
- FDA Grants DeNovo Classification to Balance Ophthalmics' FYSX Ocular Pressure Adjusting Pumphttps://modernod.com/news/fda-grants-denovo-classification-to-balance-ophthalmics-fysxtm-ocular-pressure-adjusting-pump/2482333/Balance Ophthalmics announced that the FDA has granted DeNovo Classification of the FYSX Ocular Pressure Adjusting Pump, a new category of treatment for patients with normal tension glaucoma (NTG) and open-angle glaucoma (OAG) with IOP ≤ 21 mmHg. “The FDA classif
- Ikerian Receives EU-MDR Certificate for Four Devices, its Ophthalmology Data Platform and AI Modelshttps://modernod.com/news/ikerian-receives-eu-mdr-certificate-for-four-devices-its-ophthalmology-data-platform-and-ai-models/2482328/Ikerian announced it has received a European Union Medical Device Regulation (EU-MDR) certificate as Class IIa medical devices for its RetinAI Discovery digital data platform, as well as AI-based models to identify and quantify retinal layers
- Nidek Launches the RS-1 Glauvas Optical Coherence Tomography Devicehttps://modernod.com/news/nidek-launches-the-rs-1-glauvas-optical-coherence-tomography/2482304/Nidek has launched the RS-1 Glauvas Optical Coherence Tomography (OCT). The RS-1 Glauvas has up to 250kHz scan speed, wide and deep area imaging, operability, and deep learning-based analytics. The incorporation of 250,000 A-scans/s accelerates the workflow by reducing capture
- Merck to Acquire EyeBio in a Deal Worth Up to $3 Billionhttps://modernod.com/news/merck-to-acquire-eyebio-in-a-deal-worth-up-to-3-billion/2482297/After a decade away, Merck will be re-entering the ophthalmology industry after agreeing to acquire privately-held Eyebiotech (EyeBio), maker of Restoret (EYE103), an investigational first-in-class treatment for retinal diseases. Under the terms of the dea