Ophthalmics

Retina Implant AG, the leading developer of subretinal implants for patients blinded by retinitis pigmentosa, has announced that its wireless subretinal implant technology, the Alpha IMS, has received CE Mark.

Visiometrics has gained CE mark approval for the next generation of its Optical Quality Analysis System, the HD Analyzer. Launch follows.

Abbott has announced that the TECNIS® Toric 1-Piece intraocular lens has received U.S. FDA approval and is launching in the United States for the treatment of cataract patients with pre-existing corneal astigmatism.

Bausch + Lomb, has extended the CE mark status for its VICTUS® femtosecond laser platform to include the creation of corneal incisions in patients undergoing cataract surgery. Two other new indications were included, including penetrating keratoplasty and the creation of intrastromal channel incisions for intracorneal ring segments.

This envelope must have been an unpleasant one to open. Following an inspection of Alcon Inc.’s Aliso Viejo site in California, the agency wrote a stinging warning letter to the company citing a number of serious shortfalls in its activities.

Second Sight Medical’s Argus® II Retinal Prosthesis System is the first approved bionic eye in the US with life-changing potential for the treatment of blindness due to retinitis pigmentosa

Freedom Meditech’s clever lens-fluorescence biomicroscope is a non-invasive ophthalmic diagnostic device that obvates the need for dilation drops and claims greater precision than current standard of care devices.

Diagnostic device company Welch Allyn, has received FDA 510(k) clearance to market its iExaminer™ iPhone compatible image capture system that allows healthcare providers to capture, store, send and retrieve images from the Welch Allyn PanOptic™ Ophthalmoscope using the iPhone® 4 or 4S.

Iridex Corporation has gained FDA 510(k) and CE clearance of the TxCell Scanning Laser Delivery System which it says saves significant time in a variety of laser photocoagulation procedures in allowing physicians to deliver the laser in a multi-spot scanning mode, rather than the traditional single spot mode.

An article in November’s Ophthalmology talks about ultra-small drainage devices for use in facilitating drainage and therefore reducing intraocular pressure in some glaucoma patients. Results presented at AAO meeting this week suggest the Ivantis Hydrus microstent is clinically effective.

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.

Georgia’s Mimedx Group is a developer of biomaterial solutions for surgical repair of soft tissues using human amniotic membrane. Pretty specialised field and never likely to be sponsoring the Olympics, but nonetheless the company’s recently stated Q2 financials suggest it’s in good shape, having grown consistently and turned red numbers black in the past twelve months.

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.