Latest News - FDA Approval/Clearance

Thursday, January 05, 2017 | FDA Approval/Clearance, Genentech

FDA Approves Lucentis for Myopic Choroidal Neovascularization

Genentech announced that the FDA has approved Lucentis (ranibizumab) 0.5 mg for the treatment of patients with myopic choroidal neovascularization (mCNV). Lucentis is the first FDA-approved anti-vascu…

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Tuesday, January 03, 2017 | FDA Approval/Clearance, Medical Studies

New Drug Approvals Fall to Six-Year Low in 2016

Last year turned out to be a disappointing one for new drug approvals with the U.S. Food and Drug Administration clearing just 22 new medicines for sale, the lowest number since 2010 and sharply down …

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Friday, December 23, 2016 | FDA Approval/Clearance, Alcon

Alcon Receives FDA Approval for AcrySof IQ ReSTOR +3.0D Multifocal Toric IOL

Alcon has received approval from the FDA for its AcrySof IQ ReSTOR +3.0D Multifocal Toric IOL. The new IOL is designed to address presbyopia and pre-existing corneal astigmatism at the time of ca…

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Tuesday, December 20, 2016 | FDA Approval/Clearance, SalutarisMD

Salutaris Medical Devices Receives 510(k) Clearance from the FDA for SMD-Sr90-DA Radionuclide Brachytherapy Source

Salutaris Medical Devices has received 510(k) clearance from the FDA for their SMD-Sr90-DA Radionuclide Brachytherapy Source (RBS). The SMD-Sr90-DA RBS device is indicated for episcleral brachytherapy…

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Tuesday, November 29, 2016 | FDA Approval/Clearance, Product Releases, OD-OS GmbH

Compact Navilas Laser System 577s Receives FDA Clearance

OD-OS announced FDA 510(k) clearance and immediate US commercial availability of the Navilas 577s, a compact all-digital system for navigated focal and peripheral laser treatments. The Navilas 577s…

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Tuesday, November 22, 2016 | FDA Approval/Clearance, Product Releases, Allergan, MIGS

Allergan Receives FDA Clearance for the XEN Gel Stent, a New Surgical Treatment for Refractory Glaucoma

Allergan announced that the FDA has cleared the XEN Glaucoma Treatment System, which consists of the XEN45 Gel Stent and the XEN Injector. The XEN Glaucoma Treatment System reduces IOP in patients and…

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Thursday, November 17, 2016 | FDA Approval/Clearance, Product Releases, Carl Zeiss Meditec

Zeiss Receives FDA Clearance for Swept-Source OCT Posterior Ocular Imaging with PLEX Elite 9000

Carl Zeiss Meditec has received FDA clearance for the Zeiss PLEX Elite 9000, the first swept-source OCT imaging technology for posterior ocular structures, according to a company news release. The swe…

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Wednesday, October 12, 2016 | FDA Approval/Clearance, Product Releases, Nidek

Nidek Receives FDA 510(k) Clearance for the MP-3 Microperimeter

The FDA has issued 510(k) clearance for Nidek's MP-3 Microperimeter, which measures local retinal sensitivity for functional assessment of the retina. The results can be displayed over a col…

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Wednesday, September 21, 2016 | FDA Approval/Clearance, Heidelberg Engineering

Heidelberg Engineering Receives FDA Clearance to Market Spectralis OCT Glaucoma Module Premium Edition

Heidelberg Engineering announced that it has received FDA 510(k) clearance to market the Spectralis OCT Glaucoma Module Premium Edition, which provides a comprehensive analysis of the optic nerve head…

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Tuesday, September 20, 2016 | FDA Approval/Clearance, Product Releases, Nidek

Nidek Receives FDA 510(k) Clearance for the GYC-500/GYC-500 Vixi Green Scan Laser Photocoagulator

Nidek announced that the FDA has issued 510(k) clearance for the GYC-500/GYC- 500 Vixi Green Scan Laser Photocoagulator. With the clearance, the device is now available in the United States. …

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Tuesday, September 13, 2016 | FDA Approval/Clearance, Carl Zeiss Meditec

FDA Approves VisuMax Femtosecond Laser to Surgically Treat Myopia

Ophthalmologists in the United States will have an entirely new option in the surgical treatment of myopia as the FDA announced the approval of the VisuMax Femtosecond Laser ReLEx SMILE procedure. The…

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Thursday, September 08, 2016 | FDA Approval/Clearance, Nidek

Nidek Receives 510(k) Clearance for the Manual Analysis Function for the CEM-530 Specular Microscope

Nidek announced that the FDA has issued 510(k) clearance for the manual analysis function for the CEM-530 Specular Microscope. This feature will enable practitioners to analyze cells manually that are…

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Wednesday, August 03, 2016 | FDA Approval/Clearance

Advanced Vision Technologies Receives FDA Clearance for EyePrintPRO

Advanced Vision Technologies has announced the FDA clearance for manufacturing the EyePrintPRO prosthetic scleral device and the proprietary EyePrint Impression Process. The EyePrint Impression Proces…

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Monday, August 01, 2016 | FDA Approval/Clearance, Topcon Medical Systems

Topcon’s 3D OCT-1 Maestro Receives FDA Clearance

Topcon Medical Systems has announced that the 3D OCT-1 Maestro is now available for sale in the United States. The 3D OCT-1 Maestro System combines a high-resolution color nonmydriatic retinal camera …

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Friday, July 29, 2016 | FDA Approval/Clearance, Alcon, Transcend Medical

FDA Approves CyPass Micro-Stent Minimally Invasive Glaucoma Surgical Device

The FDA has approved Alcon's CyPass Micro-Stent system, the second minimally invasive glaucoma surgical device (MIGS) approved for use in combination with cataract surgery. The device helps to red…

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