Archives: FDA Approval/Clearance
Monday, May 20, 2013
R-Tech Ueno Receives FDA IND Approval for RU-101 (r-HSA) to Treat Severe Dr...
From R-Tech Ueno
R-Tech Ueno announced that it has received FDA approval for its investigational new drug application for ecombinant human serum albumin-containing ophthalmic solution (RU-101). The approval allows R-Tech Ueno us to initi... Read full article
Monday, May 20, 2013
Alcon Announces FDA approval of Simbrinza Suspension, a New Beta Blocker-Fr...
From Eyewiretoday.com
Alcon Laboratories, Inc., announced the FDA approval of Simbrinza suspension, indicated for the reduction of elevated IOP in patients with primary open-angle glaucoma or ocular hypertension. According to a company news r... Read full article
Monday, May 20, 2013
Abbott Announces FDA Approval and US Launch of the Tecnis Toric IOL
From Eyewiretoday.com
Abbott Medical Optics Inc. announced at the American Society of Cataract and Refractive Surgery Annual Meeting that the Tecnis Toric 1-Piece IOL received FDA approval for the treatment of cataract patients with preexisti... Read full article
Monday, May 20, 2013
Bausch + Lomb Receives FDA Approval for Prolensa (Bromfenac Ophthalmic Solu...
From EyewireToday.com
The FDA has approved Prolensa (bromfenac ophthalmic solution; Bausch + Lomb) 0.07% prescription eye drop, a once-daily NSAID for the treatment of postoperative inflammation and reduction of ocular pain in patients who ha... Read full article
Monday, May 20, 2013
Lensar Laser System Receives FDA Clearance for Arcuate Incisions in Catarac...
From Lensar Inc.
Lensar Inc. announced that the company's Lensar Laser System has received 510(k) clearance from the FDA for the execution of arcuate incisions during cataract surgery. With this latest regulatory milestone, the Lensar La... Read full article
Monday, May 20, 2013
FDA Approves Canagliflozin, a First-in-Class Diabetes Drug
From Medscape Ophthalmology
The US Food and Drug Administration (FDA) today approved a novel glucose-lowering agent, canagliflozin (Invokana, Janssen Pharmaceuticals) for the treatment of adults with type 2 diabetes. Canagliflozin is the first in a... Read full article
Monday, May 20, 2013
Quantel Medical Receives FDA Clearance for New Vitra Multispot Laser System
From Quantel Medical
Quantel Medical today announced the US Food and Drug Administration (FDA) 510(k) market clearance of the Vitra Multispot laser. The product was developed by Quantel Medical to give access to advanced pattern-scanning tec... Read full article
Monday, May 20, 2013
ThromboGenics JETREA Granted EU Approval for Vitreomacular Traction (VMT)
From ThromboGenics NV
ThromboGenics NV, an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces that the European Commission has approved JETREA (ocriplasmin) in the E... Read full article
Monday, May 20, 2013
AcuFocus Submits PMA to FDA for Approval of the KAMRA Inlay
From AcuFocus
AcuFocus has submitted the final module of their premarket approval application (PMA) for the KAMRA corneal inlay to the US Food and Drug Administration (FDA).After 10 years of development and thousands of patients treat... Read full article
Monday, May 20, 2013
Optos Receives FDA Clearance for Microperimetry as Part of the Optos OCT SL...
From Optos PLC
Optos PLC announced that it has received 510(k) clearance from the FDA for Microperimetry as part of the Optos OCT SLO. Microperimetry assesses retinal sensitivity providing a precise correlation between structural patho... Read full article
Monday, May 20, 2013
ReVision Optics Receives FDA Approval to Complete Enrollment in Its Phase 3...
From ReVision Optics
ReVision Optics, Inc. has received conditional approval from the FDA to continue and complete enrollment in its phase 3 clinical trial with its Raindrop Near Vision Inlay (formerly the PresbyLens). The prospective, mult... Read full article
Monday, May 20, 2013
FDA Approves New Silicone Breast Implant From Allergan
From Fox News
Health regulators said on Wednesday they have approved a new silicone gel-filled breast implant made by Allergan Inc. The U.S. Food and Drug Administration said it approved Allergan's Natrelle 410 implants to increase br... Read full article
Monday, May 20, 2013
Optovue Receives FDA Clearance of iCam Non-Mydriatic Fundus Camera
From Optovue
Optovue has received 510(k) clearance for the iCam Non-Mydriatic compact fundus camera. The iCam camera produces 45 color fundus images of the eye as well as external ocular structures. Even with its compact size, the iC... Read full article
Monday, May 20, 2013
Argus II System Receives FDA Approval for "Bionic Eye" to Treat Late-Stage ...
From EyewireToday.com
The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc.), a device that provides electrical stimulation of the retina to induce visual perception in blind individuals with retinitis pigmentosa, receiv... Read full article
Monday, May 20, 2013
Victus Femtosecond Laser Platform Receives FDA Clearance for Arcuate Incisi...
From EyewireToday.com
The Victus Femtosecond Laser Platform (Bausch + Lomb) received 510(k) clearance from the FDA for the creation of penetrating arcuate cuts/incisions in the cornea in patients undergoing cataract surgery or other ophthalmi... Read full article
Monday, May 20, 2013
Welch Allyn iExaminer Receives 510(k) Clearance from the FDA
From Welch Allyn
Welch Allyn announced it has received 510(k) clearance from the FDA for the Welch Allyn iExaminera product that consists of a hardware adapter and associated software that allows healthcare providers to capture, store, s... Read full article
Monday, May 20, 2013
LipiView Version 2.0 Software Receives US FDA Clearance, Enhances Physician...
From EyewireToday.com
TearScience, Inc. announced that the FDA has cleared additional features and broadened the indication for use of the company's LipiView Ocular Surface Interferometer. LipiView now measures the absolute thickness of the t... Read full article
Monday, May 20, 2013
FDA Approves the Oculus Corvis ST
From Oculus
As the first non-contact tonometer and optical pachymeter, the Oculus Corvis ST has received the approval of the US Food and Drug Administration (FDA). The qualification for the approval, amongst others, was based on a s... Read full article
Monday, May 20, 2013
Eight FDA Approvals in December Boosts 2012 to Banner Year for New Drugs
From Burrill & Company
The U.S. Food and Drug Administration approved eight new drugs in December pushing the year's total to 39, its highest level since 1996 when the agency cleared a backlog of applications. Though December's newly approved ... Read full article
Monday, May 20, 2013
FDA: New Plan to Speed Drug Development
From Medpage Today
The FDA has issued guidance outlining how drug companies can select patients more likely to show a benefit from a studied drug and how companies can help improve the speed and efficiency of clinical trials. In draft guid... Read full article
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