The United States Food and Drug Administration (FDA) issued an approval letter for the Planmed Clarity 2D full-field digital mammography system on December 28, 2017.
The Planmed Clarity 2D system is a digital mammography system for breast cancer screenings. In addition to screening mammograms, the system supports diagnostic work-up examinations and biopsy procedures.
Jan Moed, managing director of Planmed Oy, said the FDA approval for the system is an important milestone for the Planmed Clarity product family.
“The functional design of the unit guarantees optimal ergonomics for both the radiographer and the patient. The compact and eye-pleasing design relieves patient anxiety, and the flexible compression paddle adapts to patients of all sizes making the patient experience comfortable and relaxed,” according to a news release.
“Planmed Clarity’s customizable image processing options serve various radiology needs. 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,” stated Planmed Clinical Director Jukka Erkkilä.
Planmed products are sold, marketed and supported in North America by Planmed USA Inc.