The FDA recently granted authorization to LumiThera, Inc., allowing the company to market its Valeda Light Delivery System. This approval, made under the De Novo authorization pathway, makes Valeda the first FDA-authorized device to treat vision loss in patients with dry AMD. I had the opportunity to speak with LumiThera President and CEO Clark Tedford to learn more about the Valeda technology, its role in the dry AMD market, and the company’s commercialization plans. https://lnkd.in/g28Q9Wxy Eyewire+
LumiThera, Inc.
医疗设备制造业
Poulsbo，Washington 1,955 位关注者
Valeda is FDA Authorized in the US, CE Marked in the EU, and available in select countries in Latin America.
关于我们
LumiThera, Inc. is an ophthalmic medical device company that is Harnessing the Power of Light™ to offer a comprehensive approach for detecting, treating, and monitoring retinal diseases, particularly dry age-related macular degeneration (AMD). LumiThera is the leader in ophthalmic photobiomodulation (PBM) innovation with its flagship product, the Valeda® Light Delivery System. Multiwavelength Valeda treatments are for patients suffering from dry AMD. Valeda is FDA Authorized in the US, CE Marked in the EU, and available in select countries in Latin America. AdaptDx Pro® is a portable dark adaptometer that utilizes AI to deliver a uniform patient experience. Impaired dark adaptation is the earliest biomarker of AMD and can be detected three years before clinical presentation. AdaptDx Pro is available in the U.S. and Canada. NOVA Vision Testing System is a comprehensive electrophysiology platform that provides objective assessment of the entire pathway for visual and neuro-visual disorders. VEP is available in the U.S. and select countries outside of the U.S. ERG is only available outside of the U.S. For more information on Valeda, visit www.lumithera.com. AdaptDx Pro and NOVA are available through LumiThera Diagnostics, Inc. and Diopsys, Inc., respectively.
- 网站
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http://lumithera.com
LumiThera, Inc.的外部链接
- 所属行业
- 医疗设备制造业
- 规模
- 11-50 人
- 总部
- Poulsbo，Washington
- 类型
- 私人持股
- 领域
- Photobiomodulation、Age Related Macular Degeneration、Ophthalmology、Medical Device、PBM Therapy、Medtech、LLLT、PBM、dry AMD和Retina
地点
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主要
获取路线
4058 NE Lookout Lane
US，Washington，Poulsbo，98370
LumiThera, Inc.员工
动态
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The CEO of Lumithera joins us to discuss the FDA authorization of the Veleda system for dry AMD; the FDA accepts the resubmitted NDA for dry eye disease candidate reproxalap; and Alcon launches the first contact lens designed for a 1-week replacement cycle: https://bit.ly/3ASkVR0
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Clark Tedford, Phd, LumiThera President and CEO, will be presenting at OIS XIV on Saturday, November 23rd in the Retina Innovation Showcase. Hope to see you there! #OIS #OISXIV #Ophthalmology #Innovation https://ois.net/ois-xiv/
OIS XIV Home | Ophthalmology Innovation Source
https://ois.net
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The FDA has granted authorization to LumiThera allowijng the company to market its Valeda Light Delivery System. This approval, made under the De Novo authorization pathway, makes Valeda the first FDA-authorized device to treat vision loss in patients with dry AMD: https://bit.ly/4ehfGYL
LumiThera Obtains FDA Authorization of Valeda Treatment for Dry AMD - Eyewire+
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Today, the U.S. Food & Drug Administration (FDA) authorized marketing of the Valeda® Light Delivery System for treatment of patients with dry age-related macular degeneration (AMD). It's time for patients to see their future. https://lnkd.in/dJ5JznCX #retina #ophthalmology #vision #dryAMD
LumiThera Obtains FDA Authorization of Valeda Treatment for Dry AMD Patients to Improve Vision
businesswire.com
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We're excited to attend #Academy24 on November 6-6 in Indianapolis. Stop by booth 601 to meet with the LumiThera team. See you there!
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The LumiThera team is in Chicago at AAO! Visit booth 4252 to meet the team and learn more! #aao2024 #retina #ophthalmology #dryAMD #vision
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MD, PhD, FEBO. Ophthalmologist. Refractive surgery and Retina specialist at Clinica Villoria Oftalmólogos
Happy to share our 1st year- real life results of Valeda Therapy in Atrophic AMD patients. This promising therapy based on photobiomodulation has the main goal of preventing loss of vision in Age Related Macular Degeneration (AMD), the first cause of legal blindness in developed countries. We’ll be sharing our personal experience and results in the LumiThera, Inc. User’s Meeting at European Society of Retina Specialists (EURETINA) Congress as well as in the 100th Congress of the Sociedad Española de Oftalmología. - Ilusionado por compartir nuestros resultados en práctica real de nuestro 1er año de experiencia con Valeda en pacientes con DMAE atrófica. Esta prometedora terapia basada en la fotobiomodulación tiene como objetivo principal prevenir la perdida de visión en pacientes con Degeneración Macular asociada a la Edad (DMAE), que constituye la primera causa de cegera legal en paises del mundo desarrollado. Compartiremos nuestra experiencia personal y resultados en el User’s Meeting de LumiThera, Inc. dentro del congreso de la Sociedad Europea de Especialistas en Retina, además del 100 congreso de la Sociedad Española de Oftalmología. #retina #agerelatedmaculardegeneration #Valeda #photobiomodulation #AMD #DMAE #dryAMD #retinaexpert #vigo #pontevedra Clinica Villoria Oftalmólogos Vista Oftalmólogos
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The LumiThera team at the Congreso SEO in Madrid, Spain! #retina #ophthalmology #Valeda #LumiThera #DryAMD
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Day 1 of Euretina is underway. Be sure to visit booth D8 to learn more about the Valeda Light Delivery System and our latest clinical data. #euretina2024 #retina #ophthalmology
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