Latest News - FDA Approval/Clearance

Wednesday, November 22, 2017 | FDA Approval/Clearance, Product Releases, RxSight

FDA Approves RxSight's Light Adjustable Lens, First IOL to Enable Refractive Correction After Cataract Surgery

RxSight announced that the FDA has approved the RxSight Light Adjustable Lens and the Light Delivery Device for patients with pre-existing astigmatism of ≥0.75 D undergoing cataract surgery. This a…

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Thursday, November 02, 2017 | FDA Approval/Clearance, Bausch+Lomb, Nicox , Valeant

Bausch + Lomb And Nicox Announce FDA Approval of Glaucoma Treatment Vyzulta

Bausch + Lomb and Nicox announced that the FDA has approved Vyzulta (latanoprostene bunod ophthalmic solution 0.024%), indicated for the reduction of IOP in patients with open-angle glaucoma or o…

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Tuesday, October 24, 2017 | FDA Approval/Clearance, Bausch+Lomb

Bausch + Lomb Receives 510(k) Clearance from FDA on New 3.3 Software for Victus Femtosecond Laser

Bausch + Lomb announced it has received 510(k) clearance from the FDA for a new 3.3 software package and new hardware for the Victus femtosecond laser platform, which together are designed to enhance …

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Monday, October 16, 2017 | FDA Approval/Clearance, Product Releases, Topcon Medical Systems

Topcon’s PASCAL Synthesis TwinStar Laser Receives FDA 510(k) Clearance

Topcon Medical Systems announced that its PASCAL Synthesis TwinStar laser has received FDA 510(k) clearance. The Synthesis TwinStar expands the PASCAL line of laser photocoagulators offering the abili…

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Thursday, October 12, 2017 | Cataract Surgery, FDA Approval/Clearance

ARC Laser Receives FDA Approval for Cetus Nano-Laser System

ARC Laser recently received FDA approval for the use of the Cetus Nano-Laser system in cataract surgery. The Cetus system includes a base that houses the laser with a touch-screen to adjust the laser …

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Tuesday, October 03, 2017 | FDA Approval/Clearance

FDA Aims to Reduce the Hurdles for Complex Generic Drug Development

FDA Commissioner Scott Gottlieb on Monday announced a number of initiatives designed to hasten the approval of complex generic drugs. Below is a letter he wrote outlining the new initiatives…

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Monday, September 25, 2017 | FDA Approval/Clearance

Ampleye Scleral Contact Lens Now FDA Approved for Ocular Surface & Dry Eye Disease Management

Art Optical Contact Lens has received 510(k) clearance from the FDA on their Ampleye Scleral lens for the therapeutic management of ocular surface disease from dry eye. The specific therapeutic ind…

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Friday, September 15, 2017 | FDA Approval/Clearance

FDA Approves First Biosimilar for the Treatment of Cancer

The FDA approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the United States for the tr…

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Thursday, August 31, 2017 | FDA Approval/Clearance

Contamac Announces FDA Clearance of HEXA100 Gas Permeable Material

Contamac has announced FDA clearance of its hexafocon A material, HEXA100. The clearance has been granted for spherical, toric, multifocal/bifocal, irregular cornea and orthokeratology indications as …

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Thursday, August 31, 2017 | FDA Approval/Clearance

FDA Approval Brings First Gene Therapy to the United States

The FDA issued a historic action making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases. …

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Wednesday, August 09, 2017 | FDA Approval/Clearance

Ocugen Receives FDA Orphan Drug Designation for OCU300 (Brimonidine Tartrate) for the Treatment of Ocular Graft Versus Host Disease

Ocugen announced that the FDA has granted orphan drug designation for OCU300 (brimonidine tartrate) for the treatment of ocular graft versus host disease (oGVHD). Ocular GVHD is a common complication …

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Wednesday, August 09, 2017 | FDA Approval/Clearance, Bausch+Lomb

Bausch + Lomb Receives FDA 510(k) Clearance for the Therapeutic Use of Boston XO and Boston XO2 Materials

Bausch + Lomb announced it has received 510(k) clearance from the FDA for the therapeutic use of its Boston XO and Boston XO2 materials in treating several ocular surface diseases. The Boston XO and B…

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Tuesday, August 08, 2017 | FDA Approval/Clearance, Optovue

Optovue First in US to Receive FDA Clearance for Corneal Epithelial Thickness Mapping

Optovue announced today the FDA has cleared the company’s epithelial thickness mapping software (epi-mapping) for quantitative measurements of the epithelial and stromal layers of the cornea. Ep…

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Thursday, July 27, 2017 | FDA Approval/Clearance, Product Releases, Quantel Medical

Quantel Medical Receives FDA Approval for Easyret Photocoagulator Laser

Quantel Medical announced that it has received approval from the FDA for the Easyret fully integrated 577nm yellow photocoagulator, which is used to treat certain forms of macular edema and peripheral…

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Friday, July 14, 2017 | FDA Approval/Clearance, Johnson & Johnson Vision Care

FDA Approves iDesign Advanced WaveScan Studio System to Treat Hyperopia With and Without Astigmatism

The FDA has approved a new indication for the Star S4 IR Excimer Laser System and iDesign System. With the approval, the iDesign can be used for LASIK patients with hyperopia, with and without astigma…

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