Planmed Applies to FDA for Full Field Digital Mammography System

Planmed has recently submitted a premarket approval (PMA) application to the Food and Drug Administration (FDA) for the company’s Planmed Nuance* Full Field Digital Mammography System. Planmed hopes to receive the application approval before the end of the year.

The Planmed Nuance is based on amorphous selenium (a-Se) detector technology. Planmed plans to offer two detector sizes. Customers may choose either the 17 cm x 23.9 cm Bucky or the optional 23.9 cm x 30.5 cm Bucky which will accommodate most patients. The Nuance unit will also be equipped with the integrated MaxView Breast Positioning device, which provides more chest wall tissue on imaging exams.