Planmed mammography system approved in the US
Finnish healthtech company Planmed has received an approval letter from the US Food and Drug Administration (FDA) for its Planmed Clarity 2D full-field digital mammography system.
The Planmed Clarity 2D system for breast cancer screenings was developed with usability in mind, while its eye-pleasing design aims to put patients at ease. Apart from screening mammograms, the system supports diagnostic work-up examinations and biopsy procedures.
According to Planmed’s managing director Jan Moed, the green light from the US is an important milestone for the Planmed Clarity product family.
“We are excited that we can now introduce our fantastic Planmed Clarity 2D system in the United States,” Moed comments. “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 US market as well.”
Moed also underlines that the system is a complete and cost-effective solution without compromising quality. It also lends itself for use in trying conditions, such as humid environments and mobile clinic installations.