Latest News - FDA Approval/Clearance

Monday, April 17, 2017 | FDA Approval/Clearance, Retina, Genentech

FDA Approves Lucentis for All Forms of Diabetic Retinopathy

Genentech announced that the FDA has approved Lucentis (ranibizumab) 0.3 mg for the monthly treatment of all forms of diabetic retinopathy. With this approval, Lucentis becomes the first and only FDA-…

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Friday, April 07, 2017 | FDA Approval/Clearance, Medical Studies

Study Finds FDA Outpaces European Regulators in Review Times, Approvals of New Drugs

A new study published online in the New England Journal of Medicine reveals that the FDA outpaced the European Medicines Agency (EMA) in review times and approval of new drugs during a recent 5 year-p…

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Thursday, April 06, 2017 | FDA Approval/Clearance, Product Releases, Bausch+Lomb

Bausch + Lomb Receives FDA 510(k) Clearance for Stellaris Elite Phacoemulsification Platform

Bausch + Lomb announced that it has received 510(k) clearance from the FDA for the Stellaris Elite vision enhancement system, the company’s next generation phacoemulsification platform. The mach…

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Thursday, March 23, 2017 | FDA Approval/Clearance

Icare USA Receives FDA Clearance for Icare HOME Tonometer

Icare USA announced that the Icare HOME tonometer has been cleared by the FDA and is now available for use in the United States. The Icare HOME device, which received CE marking in 2014, allows eye ca…

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Thursday, March 23, 2017 | FDA Approval/Clearance, Alcon

Alcon Receives FDA Approval for AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL with Activefocus

Alcon has received approval from the FDA for its AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL with Activefocus, which is designed to address astigmatism and presbyopia at the same time. The unique opti…

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Monday, March 06, 2017 | FDA Approval/Clearance, Carl Zeiss Meditec

First SMILE Vision Correction Procedure for Myopia Performed in the US

Following the recent FDA approval for the ReLEx SMILE (small-incision lenticule extraction) procedure, Jon G. Dishler, MD, at the Dishler Laser Institute, became the first to perform this procedure on…

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Wednesday, March 01, 2017 | FDA Approval/Clearance, Product Releases, Topcon Medical Systems

The Aladdin Biometer and Corneal Topographer HW3.0 Receives 510(k) Clearance

Topcon Medical Systems has announced that the Aladdin Biometer with Corneal Topographer HW3.0 has obtained FDA clearance for distribution in the United States. This new version of the Aladdin Bi…

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Wednesday, March 01, 2017 | FDA Approval/Clearance, Carl Zeiss Meditec

ReLEx SMILE Procedure Now Commercially Available in the US

Carl Zeiss Meditec announced that it has received FDA approval of a software update to the Zeiss VisuMax femtosecond laser system for the ReLEx SMILE (small-incision lenticule extraction) procedure. W…

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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

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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