Showing 2301-2310 of 5909 results for "".
- 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
- Opthea Welcomes International Retina Thought Leaders to Its Medical Advisory Boardhttps://modernod.com/news/opthea-welcomes-international-retina-thought-leaders-to-its-medical-advisory-board/2482361/Opthea announced the formation of its Medical Advisory Board, which will comprise of 10 retina thought leaders from countries around the world, including the US, Argentina, Australia, China, France, Germany, and Israel. Chaired by Arshad M. Khanani, MD, MA, FASRS, Chief Medica
- 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
- 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
- EyeCare Partners Names New Members to Executive Leadership Teamhttps://modernod.com/news/eyecare-partners-names-new-members-to-executive-leadership-team/2482321/EyeCare Partners announced new additions and changes to its executive leadership team. Appointments and changes are: Andrew Hardesty has been promoted to the new role of Chief Program Officer, effective immediately. This role oversees and lea
- 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
- Topcon Healthcare Partners with Microsoft to Deliver AI-Powered ‘Healthcare from the Eye’https://modernod.com/news/topcon-healthcare-partners-with-microsoft-to-deliver-ai-powered-healthcare-from-the-eye/2482274/Topcon Healthcare announced a partnership with Microsoft Corporation to deliver AI-powered ‘Healthcare from the Eye’ solutions to improve healthcare access, cost, and quality. A cloud-based connected network of healthcare providers using the 'Nuance Precision I
- False Claims Act Complaint Filed Against Regeneron for Fraudulent Drug Pricing Reportinghttps://modernod.com/news/false-claims-act-complaint-filed-against-regeneron-for-fraudulent-drug-pricing-reporting/2482228/The US Department of Justice (DOJ) has filed a complaint under the False Claims Act (FCA) against Regeneron alleging that the company fraudulently inflated Medicare reimbursement rates for Eylea (aflibercept) by knowingly submitting false average sales price reports to CMS that excluded
- First Patient Enrolled in LYNX-2 Phase 3 Study Evaluating Phentolamine for the Treatment of Decreased VA Under Low Light Conditions Following Keratorefractive Surgeryhttps://modernod.com/news/first-patient-enrolled-in-lynx-2-phase-3-study-evaluating-phentolamine-for-the-treatment-of-decreased-va-under-low-light-conditions-following-keratorefractive-surgery/2482227/Ocuphire Pharma announced the enrollment of the first subject in the LYNX-2 phase 3 registration study evaluating phentolamine ophthalmic solution 0.75% (PS) for the treatment of decreased visual acuity under low (mesopic) light conditions following keratorefractive surgery. The LY