FDA clears Planmed's 2D digital mammography system

Mammography and orthopedic imaging firm Planmed has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its 2D full-field digital mammography device.

Clarity 2D offers an array of features including customizable image processing and a digital detector that enables it to function in extreme conditions, the company said. The device received the European Economic Area's CE Mark in 2016.

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