Latest News - FDA Approval/Clearance

Monday, June 05, 2017 | FDA Approval/Clearance

Zepto Capsulotomy System Receives FDA 510(k) Clearance

Mynosys Cellular Devices announced that it has received 510(k) clearance from the FDA for the Zepto Capsulotomy System. Zepto uses a proprietary combination of calibrated suction and a 4-millisecond m…

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Wednesday, May 31, 2017 | FDA Approval/Clearance, Nicox

Nicox Receives FDA Approval of Allergic Conjunctivitis Treatment Zerviate

Nicox announced that the FDA has approved the new drug application for Zerviate (cetirizine ophthalmic solution 0.24%; formerly AC-170), the first topical ocular formulation of the antihistamine cetir…

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Monday, May 22, 2017 | FDA Approval/Clearance, Genentech

FDA Approves Genentech’s Actemra for Giant Cell Arteritis

Genentech announced that the FDA has approved Actemra (tocilizumab) subcutaneous injection for the treatment of giant cell arteritis (GCA), a chronic and severe autoimmune condition. Actemra is the fi…

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Saturday, May 06, 2017 | FDA Approval/Clearance

Lensar Receives FDA Clearances for Laser Cataract Platform Integration With Oculus Pentacam Tomographers

Lensar announced it received 510(k) clearance for integration of the Oculus Pentacam (both Pentacam HR and Pentacam AXL) and Aladdin topographer from Topcon to the Lensar Laser System with Streamline …

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Wednesday, April 26, 2017 | FDA Approval/Clearance, Bausch+Lomb

Bausch + Lomb Receives 510(k) Clearance from FDA for Vitesse Vitrectomy System

Bausch + Lomb announced that it has received 510(k) clearance from the FDA for Vitesse, the first and only hypersonic, 100% open port vitrectomy system, according to a company news release. This new t…

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Tuesday, April 25, 2017 | FDA Approval/Clearance, Allergan

Allergan Granted Marketing Authorization by the FDA for TrueTear Intranasal Neurostimulating Device

Allergan announced that it has been granted marketing authorization from the FDA for TrueTear Intranasal Tear Neurostimulator, the first and only FDA-cleared device developed to temporarily increase t…

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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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