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Archives: FDA Approval/Clearance

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Friday, August 15, 2014

FDA Approves Genentech's Avastin Plus Chemotherapy for Treatment of Advance...

From Genentech

Genentech announced that the FDA approved Avastin (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent or metastatic carcinoma of th... Read full article

Friday, August 01, 2014

FDA to Expand Reach on Diagnostic Tests

From Medpage Today

The FDA plans to take over regulation of "home brew" diagnostic tests developed and used within individual clinical laboratories, agency officials said Thursday. "The agency is notifying Congress of its intention to publ... Read full article

Tuesday, July 29, 2014

Eylea Injection Receives FDA Approval for the Treatment of Diabetic Macular...

From Regeneron Pharmaceuticals, Inc.

Regeneron announced that the FDA has approved Eylea (aflibercept) injection for the treatment of diabetic macular edema (DME), according to a company news release. The recommended dosage of Eylea in patients with DME is ... Read full article

Thursday, July 17, 2014

Victus Femtosecond Laser Platform Receives 510(k) Clearance from FDA for Le...

From Bausch + Lomb

Valeant announced that its wholly owned subsidiary, Bausch + Lomb, has received 510(k) clearance from the FDA for the Victus Femtosecond Laser Platform for laser-assisted lens fragmentation during cataract surgery, accor... Read full article

Wednesday, July 09, 2014

Quantel Medical's Optimis Fusion Receives FDA 510(k) Clearance

From Quantel Medical

Quantel Medical announced FDA 510(k) clearance for its Optimis Fusion integrated laser platform, according to a company news release. The Optimis Fusion system combines selective laser trabeculoplasty (SLT) photoregenera... Read full article

Monday, June 30, 2014

Bausch + Lomb Receives FDA Clearance for Biotrue ONEday for Presbyopia Lens...

From Bausch + Lomb

Bausch + Lomb announced that the FDA has issued marketing clearance for Biotrue ONEday for Presbyopia (nesofilcon A) soft (hydrophilic) contact lens, the first daily disposable multifocal contact lens from the Biotrue ON... Read full article

Monday, June 30, 2014

Allergan Announces FDA Approval of DME Treatment Ozurdex and Provides R&D P...

From Eyewiretoday.com

Allergan has received approval from the FDA for Ozurdex (dexamethasone intravitreal implant) 0.7 mg as a treatment for diabetic macular edema (DME) in adult patients who are pseudophakic or who are scheduled for cataract... Read full article

Thursday, June 05, 2014

Paragon BioTeck Announces FDA-Approved Phenylephrine Hydrochloride Ophthalm...

From Paragon BioTeck, Inc.

Paragon BioTeck announced its FDA-approved Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, to dilate the pupil, is readily available through Bausch + Lomb or a primary wholesaler, according to a c... Read full article

Wednesday, June 04, 2014

Centervue Announces FDA Clearance of Next Generation Macular Integrity Asse...

From Centervue

CenterVue announced FDA 510(k) clearance for the company's next generation Macular Integrity Assessment (MAIA), according to a company news release. MAIA offers the latest advances in scanning laser ophthalmoscopy (SLO) ... Read full article

Monday, June 02, 2014

Omeros Receives FDA Approval of Omidria for Use in Cataract and Other Intra...

From Omeros Corp.

Omeros announced that the FDA has approved Omidria (phenylephrine and ketorolac injection) 1%/0.3% for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosi... Read full article

Wednesday, April 23, 2014

New FDA Program Would Speed Up Access to Medical Devices

From Medscape Ophthalmology

The US Food and Drug Administration (FDA) has proposed a new program designed to grant earlier access to high-risk medical devices intended to treat or diagnose patients with serious conditions whose needs are unmet by c... Read full article

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

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