Visunex Medical Systems, a firm based in Fremont, California, got hold of FDA clearance for its new PanoCam Pro Wide-field Imaging System used for identifying external, anterior, and posterior segment vision disorders in newborn infants. The system is intended to be used for screening all newborns arriving at any hospital equipped with a PanoCam Pro […]
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Lower humidity and higher ozone levels were associated with dry eye disease in a South Korean population, according to Sung Ha Hwang, MD, and colleagues.The researchers reported in JAMA Ophthalmology that they collected air pollution measurements, such…
FORT LAUDERDALE, Fla. — Patient preferences are a part of the regulatory science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of all FDA-regulated products, Malvina B. Eydelman, MD, director of the FDA’s Division of Ophthalmic and Ear, Nose and Throat Devices, said at the American Glaucoma Society meeting. “Patient preferences is all about weighing the benefits and risks,” she said. “So for a low-benefit, high-risk device, the product may only get approved if significant evidence exists that at least a subset of patients would trade the risk for the benefit.”
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The PanoCam Pro wide-field imaging system has received FDA clearance for the imaging of newborn infants, Visunex Medical Systems announced in a press release. The wireless imaging system has the capability to detect external, anterior and posterior seg…