FDA expands labeling for SmartLight

Israeli computerized light box developer SmartLight this month got the go-ahead from the Food and Drug Administration for expanded labeling for its products. On June 14, the FDA cleared SmartLight’s claim that, compared with conventional light boxes, the company’s motorized system substantially improves clinicians’ ability to see more detail in films. SmartLight submitted a study of more than 1000 radiologists reading quality control mammography films to back up its 510(k) filing (SCAN 5/26/99).

The FDA also cleared SmartLight’s claim that its viewing systems can reduce effects of age on the ability of older radiologists to see small, low-contrast objects. According to SmartLight, radiologists aged 45 to 60 viewing x-rays on its light boxes can detect smaller, lower-contrast objects than their 30-year-old colleagues can using conventional light boxes.

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