FDA Introduces Draft Guidance on Patient Labeling Information for LASIK Devices

The U.S. Food and Drug Administration (FDA) on July 28 released a draft guidance paper that included recommendations for the content and presentation of patient labeling information for LASIK device labels.

FDA Introduces Draft Guidance on Patient Labeling Information for LASIK Devices
August 02, 2022
Belkin Vision's Eagle Device for Glaucoma Receives CE Mark Under MDR

Israel-based Belkin Vision announced that it has received CE Mark for its Eagle device, making it the first automated, non-contact glaucoma laser treatment available within Europe.

Belkin Vision's Eagle Device for Glaucoma Receives CE Mark Under MDR
May 17, 2022
Italian Patients Receive Samsara Vision’s SING IMT, a New Technology for AMD

Samsara Vision announced the first three successful clinical cases in Italy using its SING IMT (Smaller-Incision New-Generation Implantable Miniature Telescope) for people living with late-stage, age-related macular degeneration (AMD).

Italian Patients Receive Samsara Vision’s SING IMT, a New Technology for AMD
February 23, 2022
LENSAR Announces FDA Acceptance of 510(k) Submission for ALLY Adaptive Cataract Treatment System

LENSAR announced that the U.S. Food and Drug Administration (FDA) has accepted its 510(k) submission for its next-generation ALLY Adaptive Cataract Treatment System for substantive review.

LENSAR Announces FDA Acceptance of 510(k) Submission for ALLY Adaptive Cataract Treatment System
March 02, 2022
NovaSight Announces Successful Results of Pivotal Amblyopia Treatment Trial

NovaSight announced positive pivotal data from its multicenter, randomized, controlled trial of CureSight, an eye-tracking based, digital treatment device for amblyopia (lazy eye).

NovaSight Announces Successful Results of Pivotal Amblyopia Treatment Trial
March 11, 2022
Eyenovia's Optejet Delivery Technology Reduces Conjunctival Cell Toxicity from Preserved Ophthalmic Solutions

Eyenovia announced positive results from a research study conducted in collaboration with Pedram Hamrah, MD, Interim Chairman of Ophthalmology at Tufts Medical Center.

Eyenovia's Optejet Delivery Technology Reduces Conjunctival Cell Toxicity from Preserved Ophthalmic Solutions
March 16, 2022
Haag-Streit Launches the Imaging Module 910 Slit Lamp

Haag-Streit announced the launch of the Imaging Module 910 slit lamp. The device is instantly ready by the turn of a knob and does not require using software. Haag-Streit says capturing images is equally easy—pressing the camera trigger button is all that

Haag-Streit Launches the Imaging Module 910 Slit Lamp
March 29, 2022
Icare USA Gets FDA Clearance of iCare HOME2 Self-Tonometer

Icare USA announced 510(k) clearance from the FDA for their next generation self-tonometer, the iCare HOME2.

Icare USA Gets FDA Clearance of iCare HOME2 Self-Tonometer
March 30, 2022
DORC Receives FDA Clearance for Eva Nexus System

DORC International has announced 510(k) market clearance and the launch of the Eva Nexus.

DORC Receives FDA Clearance for Eva Nexus System
July 19, 2022
Pioneering Low-Cost Device Could Detect Eye Diseases with 3D Imaging

A pioneering low-cost device that takes 3D images could transform eye screening and treatment across the globe.

Pioneering Low-Cost Device Could Detect Eye Diseases with 3D Imaging
July 20, 2022
Daha fazla