ophthalmics

Konan Medical USA, Inc. has announced that its RAPDx® pupillograph for screening of defects in pupil function has received the European CE Mark. The company says its device breaks new ground, representing a diagnostic step change from the old “swinging flashlight” test.

IRIDEX Appoints Chairman William M. Moore as Interim President & CEO (via PR Newswire) MOUNTAIN VIEW, Calif., Aug. 28, 2012 … continue reading “New Interim President & CEO For Iridex”

Eye health company Bausch + Lomb, and Technolas ™ Perfect Vision GmbH , a leading ophthalmology laser company, have jointly announced that the VICTUS™ Femtosecond Laser Platform has received FDA 510(k) clearance. The VICTUS platform is the first femtosecond laser capable of supporting cataract and corneal procedures on a single platform.

Retinal prosthesis pioneer company Second Sight Medical Products Inc., has announced that a U.S. FDA Ophthalmic Devices Advisory Panel will take place on September 28th to review the company’s Humanitarian Device Exemption (HDE) market approval application for its Argus II Retinal Prosthesis System (Argus II prosthesis).

Abbott has announced that it has expanded its Healon® family of ophthalmic viscosurgical devices (OVDs) with the FDA approval of Healon EndoCoat OVD, a device intended for use as a surgical aid in cataract extraction and intraocular lens (IOL) implantation.

Synergetics USA, Inc., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for VersaVIT™, a novel vitrectomy system for the retinal surgery market.

Can the colour of your intraocular lenses affect your circadian rhythm and general health? Really? Our disbelief is suspended temporarily as Abbott Medical cites clinical evidence that it can.

One of the smaller devices featured on our pages, but nonetheless significant. Californian ophthalmic device company Glaukos has gained FDA approval for its iStent device, which relieves intraocular pressure in glaucoma patients.

Eye health company Bausch + Lomb claims its newly FDA approved IOL is uniquely able to claim to be glistening free.

Bioptigen Inc. has received FDA 510(k) clearance to begin marketing its hand-held Envisu Spectral Domain Ophthalmic Imaging System (SDOIS) for patient use. In receiving this regulatory clearance, Bioptigen’s Envisu SDOIS become the first optical coherence tomography(OCT) imaging system commercially available in the United States for hand-held and paediatric imaging.

Femtosecond laser technology is fairly new to the ophthalmic surgical profession, especially in the US. Now FDA has cleared Abbott’s device for the creation of curved incisions in corneal surgery including cataract access.

Researchers have developed a new system for delivering drugs to the back of the eye that could offer more effective treatment while sparing patients the excruciating routine of having drugs injected into their eyes by syringe every six to eight weeks.

US ophthalmologic imaging technology company Bioptigen Inc., has received regulatory approval to market its hand-held Envisu C2000-series systems for clinical use within the European Union

Californian company OptiMedica Corp. has announced that one member of its global Medical Advisory Board has become the first ophthalmic surgeon in Europe to treat patients with its Catalys Precision Laser System for cataract surgery.

First Single-Platform Femtosecond Laser Now Commercially Available in European Union

Rayner Intraocular Lenses Limited, the world’s original manufacturer of IOLs, has received CE Mark approval for the Sulcoflex® Multifocal Toric IOL.