Latest News - FDA Approval/Clearance

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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Monday, August 21, 2017 | FDA Approval/Clearance, Product Releases

Forus Health Announces FDA Clearance and Launch of ROP Screening Camera 3nethra NEO

After receiving FDA clearance, Forus Health announced the US launch of its retinopathy of prematurity imaging platform 3nethra NEO. The 3nethra NEO device is a wide field retinal imaging digital ca…

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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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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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