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FDA gives conditional approval for minimally invasive refraction technique to begin clinical trials
CHICAGO – The U.S. Food and Drug Administration has given conditional approval for the ReLEx smile technique to undergo clinical trials, according to Ludwin Monz, MD, president and CEO of Carl Zeiss Meditec.
The small-incision lenticule extraction (smile) technique is a flapless technique performed using femtosecond laser. The technique received CE approval and has already been launched in Europe, Dr. Monz and colleagues said at a press briefing held during the American Society of Cataract and Refractive Surgery meeting here.
Recent product upgrades announced by Dr. Monz include a software upgrade for the Cirrus HD-OCT that tracks retinal pigment epithelium changes associated with drusen in dry age-related macular degeneration and two new glaucoma applications: ganglion cell analysis and optic nerve head analysis.
“Developing products that bring forward medical diagnosis and treatment, … that is our vision for the future,” Dr. Monz said.
In keeping with the company’s intention to provide tools that combine structure and function, Dr. Monz also announced the availability of the IOLMaster 500, which integrates the Holladay 2 formula.
“We are the only ones who have this [formula] integrated into the biometer,” Tobias Damm, PhD, said.
Other product improvements include the addition of high-definition video capabilities to the Lumera 700, a pre-programmable ophthalmic microscope, and DICOM-compliant connectivity of the Humphrey Matrix 800.
Dr. Monz said that the company develops open systems in concert with DICOM standards so that physicians can integrate solutions no matter whose equipment they own.
“It’s not our approach to lock other products out,” Dr. Monz said.
- Disclosure: Dr. Monz is president and CEO of Carl Zeiss Meditec. Dr. Damm is head of Microsurgery Systems Division for Carl Zeiss Meditec.