Planmed announced Friday that it 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. The company hopes to receive the application approval before the end of the year.
“Medical facilities in Europe and Asia are already benefiting from the digital Nuance system,”said Vesa Mattila, vice president of Planmed Oy. “With the results of the DMIST trial, it is extremely important that we are able to provide this same innovative technology for the women in the United States.”
The Planmed Nuance is based on amorphous selenium (a-Se) detector technology, with the company planning 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. The unit also will be equipped with the integrated MaxView Breast Positioning device, which provides more chest wall tissue on imaging exams.