The FDA has issued an approval letter for Helsinki-based Planmed Clarity 2D full-field digital mammography system, developed to provide high image quality, ergonomics, and usability for breast cancer screenings. In addition to screening mammograms, the system supports diagnostic work-up examinations and biopsy procedures.

“We are excited that we can now introduce our fantastic Planmed Clarity 2D system in the United States,” says Jan Moed, managing director of Planmed Oy. “The system received the European Economic Area’s CE mark in early 2016, and it’s also available in Latin America, Africa, Australia, and Asia. The feedback and response the system has received from other markets has been really positive, and I believe this will be the case in the U.S. market as well.”

The functional design of the unit guarantees optimal ergonomics for both the radiographer and the patient. The design aims to relieve patient anxiety, and the flexible compression paddle adapts to patients of all sizes.

“Planmed Clarity’s customizable image processing options serve various radiology needs,” says Jukka Erkkilä, clinical director at Planmed. “The system also features a stable digital detector, which makes it suitable for working in extreme conditions, such as humid environments or mobile clinic installations. With this unit, we’re truly addressing the needs of the radiologist, radiographer, and the patient without forgetting the investment views of the clinic management.”