Planmed Oy said yesterday it won FDA approval for its Planmed Clarity 2D full-field digital mammography system.
The company said the Clarity 2D system is designed to provide improved image quality, optimal ergonomics and usability for breast cancer screenings. The system also supports diagnostic work-up examinations and biopsy procedures, Planmed said.
“We are excited that we can now introduce our fantastic Planmed Clarity 2D system in the United States. 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. It is a complete and cost-effective solution without compromising quality,” managing director Jan Moed said in a prepared statement.
“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,” Planmed clinical director Jukka Erkkilä said in a press release.