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Archives: FDA Approval/Clearance

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Monday, March 24, 2014

Bausch + Lomb's Stellaris PC Vision Enhancement System Receives 510(k) Clea...

From Eyewiretoday.com

The Stellaris PC Vision Enhancement System (Bausch + Lomb) received 510(k) clearance from the FDA for its integrated 532nm laser and software, according to a company news release. With this new capability, the Stell... Read full article

Tuesday, March 18, 2014

FDA Advisory Panel Votes in Favor of Starr Surgicals Visian Toric Implantab...

From Staar Surgical Company

Staar Surgical Company reported that its Visian Toric Implantable Lens or TICL received favorable votes to three questions presented to the FDA's Ophthalmic Devices Panel of the Medical Devices Advisory Committee, accord... Read full article

Wednesday, February 26, 2014

Victus Femtosecond Laser Platform Receives FDA Clearance for Corneal Incisi...

From Eyewiretoday.com

The Victus Femtosecond Laser Platform (Bausch + Lomb) received 510(k) clearance from the FDA for the creation of cuts/incisions in the cornea during cataract surgery, according to a company news release.The new indicatio... Read full article

Monday, February 10, 2014

FDA Panels to Consider NSAID Label Changes

From Medpage Today

Two FDA advisory committees will meet Monday and Tuesday to consider the significance of recent evidence surrounding the cardiovascular risks of nonsteroidal anti-inflammatory drugs (NSAIDs), including studies pointing t... Read full article

Monday, February 03, 2014

FDA OKs Sleep Drug for Blind Patients

From Medpage Today

The FDA has approved a treatment for sleep problems in blind patients. The melatonin receptor agonist tasimelteon (Hetlioz) is intended to treat non-24-hour sleep-wake disorder for those who are totally blind. There is c... Read full article

Friday, January 31, 2014

FDA Mulls Faster OK for High-Need Devices

From Medpage Today

The FDA wants to create an expedited approval pathway for high-risk medical devices for unmet needs, saying current tools at its fingertips are ineffective for speedier approvals. The change the agency is considering wou... Read full article

Friday, January 24, 2014

Hi-Tech Pharmacal Receives Final Approval for Bromfenac Ophthalmic Solution...

From Hi-Tech Pharmacal Co.

Hi-Tech Pharmacal Co., Inc., announced that the FDA has granted final approval for the company's abbreviated new drug application, (ANDA) for Bromfenac Ophthalmic Solution, 0.09% (Once-A-Day), the generic for ISTA Pharma... Read full article

Thursday, January 23, 2014

FDA Drug Approvals: Quality of Evidence Varies Widely

From Medscape Ophthalmology

Although many patients and physicians assume that the safety and effectiveness of new drugs are well understood, the quality of clinical trial evidence the US Food and Drug Administration (FDA) uses for approvals varies ... Read full article

Friday, January 03, 2014

FDA Approves Ophtacath - Lacrimal Duct Ballon Cathether

From FCI Ophthalmics, Inc

FCI Ophthalmics, Inc., has introduced the OphtaCath lacrimal duct balloon catheter, a device that achieves dilation of the lacrimal duct and rapidly and effectively treats the symptoms of epiphora, according to a company... Read full article

Thursday, December 05, 2013

Mobius Therapeutics Announces Ophthalmic Mutual Insurance Company Has Revis...

From Mobius Therapeutics

The Ophthalmic Mutual Insurance Company has revised its consent forms related to glaucoma filtering surgery, for the first time acknowledging the exclusive FDA-approved status of Mobius Therapeutics' Mitosol (mitomycin f... Read full article

Monday, November 25, 2013

RPS Announces FDA Clearance of Rapid, Point-of-Care Test for Dry Eye Diseas...

From Rapid Pathogen Screening, Inc.

Rapid Pathogen Screening, Inc., announced that has received clearance from the FDA for InflammaDry a rapid, disposable, in-office test to aid in the diagnosis of dry eye disease. InflammaDry is the first and only, rapid... Read full article

Sunday, November 17, 2013

Zeiss Receives FDA Approval for Expansion of US Clinical Trial for ReLEx Sm...

From Carl Zeiss Meditec AG

Carl Zeiss Meditec AG announced it has received FDA approval for the expansion for the a clinical trial in the United States for the VisuMax ReLEx smile procedure for the correction of spherical myopia, according to a co... Read full article

Thursday, November 14, 2013

Alcon WaveLight Allegretto Wave Eye-Q Excimer Laser Approved by FDA for Top...

From Eyewiretoday.com

Alcon formally announced that the FDA has approved topography-guided custom ablation LASIK procedures for its WaveLight Allegretto Wave Eye-Q excimer laser used in conjunction with the WaveLight Allegro Topolyzer and top... Read full article

Friday, November 01, 2013

FDA Issues Plan to Prevent Drug Shortages

From Medpage Today

The FDA flexed newly granted regulatory muscle on Thursday in efforts to resolve drug shortages, releasing a strategic plan and a proposed rule. The strategic plan, mandated by Congress last summer, aims to prevent short... Read full article

Tuesday, October 29, 2013

Postmarketing Studies Lag After FDA Approvals

From Medscape Ophthalmology

Of the 20 new drugs approved for marketing by the US Food and Drug Administration (FDA) in 2008, 8 received expedited reviews after significantly fewer patients were studied, according to an article published online Octo... Read full article

Monday, October 28, 2013

FDA's Hamburg on Research Investment and Clearing the Hurdles to Drug Appro...

From Medscape Ophthalmology

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg, MD, spoke with Medscape during the recent National Health Research Forum in Washington, DC, and discussed clearing the hurdles to drug and device appro... Read full article

Sunday, October 20, 2013

FDA Approves WaveLight Excimer Laser System for Topography-Guided LASIK

From Eyewiretoday.com

Alcon received FDA approval of topography-guided LASIK treatments using the companys Allegretto Wave Eye-Q 400-Hz excimer laser system in conjunction with its WaveLight Allegro Topolyzer.According to the FDA approval ord... Read full article

Friday, October 18, 2013

The FEMTO LDV Z6 Platform Receives FDA Clearance for Clear Corneal and Arcu...

From Ziemer Ophthalmic Systems AG

The Zeimer FEMTO LDV Z6 Platform, which was released in 2012 in Europe, has received clearance from the FDA for clear corneal and arcuate incisions during cataract surgery, according to a company news release.Two types o... Read full article

Friday, October 11, 2013

FDA Approves the Malyugin/Cionni Capsular Tension Ring

From Eyewire Today

FCI Ophthalmics, Inc. has introduced a new variation of the Cionni Capsular Tension Ring (CTR) from Morcher. This new design, named the Malyugin/Cionni CTR, comes preloaded on a disposable injector identified as the EyeJ... Read full article

Thursday, October 03, 2013

Bausch + Lomb Recevies FDA Clearance for Novel Monthly Disposable Contact L...

From Valeant Pharmaceuticals International...

Valeant Pharmaceuticals International, Inc. and Bausch + Lomb announced that the FDA has issued marketing clearance for Bausch + Lombs newest frequent replacement silicone hydrogel contact lenses made with MoistureSeal T... Read full article


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