Latest News - FDA Approval/Clearance

Wednesday, January 11, 2017 | FDA Approval/Clearance, OPHTEC

Ophtec USA Receives FDA Approval for RingJect Disposable Injector/Delivery System

Ophtec USA recently received FDA approval to commercially sell the RingJect, a disposable injector/delivery system designed for one-time use with capsular tension rings. With the RingJect, a CTR is pr…

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Tuesday, January 10, 2017 | FDA Approval/Clearance, Abbott Medical Optics, AMO

FDA Approves iDesign Studio System to Treat Mixed Astigmatism

The FDA has approved Abbott’s Star S4 IR excimer laser system and iDesign Advanced WaveScan Studio System for use in LASIK patients with mixed astigmatism. In a clinical study on 149 eyes tre…

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Friday, January 06, 2017 | FDA Approval/Clearance, Acucela, AMD

Acucela Receives Orphan Drug Designation from the FDA for the Treatment of Stargardt Disease

Acucela announced that the FDA granted orphan drug designation to Acucela’s leading drug candidate emixustat hydrochloride for the treatment of Stargardt disease. The orphan drug designation doe…

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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 Laboratories

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

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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