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Canada approves handheld imaging device
Health Canada has granted a medical device license to Bioptigen’s Envisu SDOIS C2200 and C2300 ophthalmic imaging systems, the Research Triangle Park, N.C.-based manufacturer said. The Envisu C series SDOIS imaging systems use low-power, near-infrared light to generate real-time, high-resolution, depth-resolved images of eye structures, according to Bioptigen. The company has said the handheld scanner makes the series “particularly useful for pediatric and non-ambulatory patients.” The devices are already approved in the E.U. and are awaiting regulatory approval in the U.S.
Kowa granted 510(k) approval for retinal camera
Kowa Optimed (Torrance, Calif.) received 510(k) approval from the FDA for its VX-20 retinal camera, the company said in a news release. The VX-20 offers non-mydriatic, mydriatic, and fluorescein angiography modes with 50-degree and 30-degree views. Additionally, the VX-20 has an autofluorescence mode to provide further diagnostic investigation of the health of the retina, the company said.
Avedro files VibeX/KXL for U.S. approval
The VibeX (riboflavin ophthalmic solution)/KXL System for the treatment of keratoconus and corneal ectasia following refractive surgery has been submitted to U.S. regulators, developer Avedro (Waltham, Mass.) said in a news release. In 2011, the VibeX/KXL System was granted orphan designation by the FDA. The VibeX/KXL System for corneal collagen crosslinking received the CE mark in 2010 and has been commercially available internationally since that approval.
SARcode enrolls final patient in dry eye study
Glaucoma now viewed as neurologic disease
Streptococcus M.O. discovered
New company to manufacture, distribute macular health eye vitamin
NEW PRODUCT BRIEFS
The following was published in EyeWorld Week last week as part of the EyeWorld Meeting Reporter from the American Glaucoma Society's annual meeting: Ziemer (Port, Switzerland) introduced the FEMTO LDV Z Models Z2, Z4, and Z6. Operating at pulse frequencies in the megahertz range and with very low pulse energy, the threshold for tissue disruption is reached at very short interaction time. The advantages are excellent visual outcomes and fast recovery. The latest models are designed to be moved between various operating theatres.
The announcement should also have included the following important information:
EYEWORLD WEEK Online is edited by Stacy Majewicz and Michelle Dalton.
EyeWorld Week Online (ISSN 1089-0319), a digital publication
of the American Society of Cataract and Refractive Surgery and
the American Society of Ophthalmic Administrators, is published
every Friday, distributed by email, and posted live on Friday.
Medical Editors: David F. Chang, M.D., chief medical editor; Bonnie An Henderson, M.D., cataract editor; Edward J. Holland, M.D., cornea editor; Reay H. Brown, M.D., glaucoma editor; Kerry D. Solomon, M.D., refractive editor; and John A. Vukich, M.D., international editor