Latest News - FDA Approval/Clearance

Thursday, January 04, 2018 | FDA Approval/Clearance

Sight Sciences Expands Surgical Portfolio with FDA Clearance of the OMNI Surgical System

Sight Sciences announced FDA 510(k) clearance for its OMNI Surgical System, a surgical tool dually indicated for the delivery of controlled volumes of viscoelastic fluid as well as the cutting of trab…

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Tuesday, January 02, 2018 | FDA Approval/Clearance

New Drug Approvals Hit 21-Year High in 2017

U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light -- more than double the previous year -- while the figure also rose in the European Union, according to a …

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Tuesday, January 02, 2018 | FDA Approval/Clearance, Bausch+Lomb

Bausch + Lomb Receives 510(k) Clearance for Crystalsert 2.6 Injector for Crystalens AO and Trulign Toric IOLs

Bausch + Lomb announced that it has received 510(k) clearance from the FDA for the Crystalsert 2.6 injector (CI-26). Designed exclusively for use across the entire diopter range of Crystalens AO and T…

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Tuesday, December 19, 2017 | FDA Approval/Clearance, Spark Therapeutics

FDA Approves First Gene Therapy for Patients with Inherited Disease

Spark Therapeutics received a landmark FDA approval as its inherited retinal disease drug Luxturna (voretigene neparvovec-rzyl), became the first gene therapy ever approved for an inherited disease. …

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Tuesday, December 19, 2017 | FDA Approval/Clearance, Spark Therapeutics

Children's Hospital of Philadelphia Celebrates FDA Approval of Gene Therapy for Inherited Blindness

Children's Hospital of Philadelphia (CHOP) joins with other research leaders in celebrating the FDA's approval of Spark Therapeutics' innovative gene therapy for the treatment of a rare, i…

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Monday, December 18, 2017 | FDA Approval/Clearance, Glaucoma, Aerie Pharmaceuticals

Aerie Pharmaceuticals Receives Long-Awaited FDA Approval of Glaucoma Treatment Rhopressa

After setbacks and years of clinical testing, Aerie Pharmaceuticals has received FDA approval of Rhopressa (netarsudil ophthalmic solution .02%) for the lowering of elevated IOP in patients with …

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Tuesday, December 12, 2017 | Cataract Surgery, FDA Approval/Clearance, Omeros

Omeros Announces FDA Approval of Omidria for Use in Pediatric Patients

The FDA has approved Omeros’ supplemental new drug application that expands the indication of Omidria (phenylephrine and ketorolac intraocular solution) 1%/0.3% to include use in pediatric patie…

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Monday, December 04, 2017 | FDA Approval/Clearance, Product Releases, Topcon Medical Systems

Pattern Scanning Laser Trabeculoplasty Program Obtains FDA Clearance

Topcon Medical Systems announced that its PASCAL Laser has received FDA clearance (K171488) to offer Pattern Scanning Laser Trabeculoplasty (PSLT) for the reduction of IOP associated with glaucoma. …

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Friday, December 01, 2017 | FDA Approval/Clearance, Health Care

FDA Aims to Expand Early-Approval Program for Promising Drugs

The Food and Drug Administration wants to help patients get faster access to promising cancer treatments. The agency is preparing proposals that would expand an accelerated-approval program for lifesa…

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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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