The Clarity+ product line features contrast-enhanced mammography and is now available in the European market.
Planmed Oy announced that its Planmed Clarity+ mammography product line has received CE MDR (Medical Device Regulation) certification, making it available for the European market.
The certification allows the Finnish medical imaging company to market its third-generation digital mammography system across the European Union. The Clarity+ line includes contrast-enhanced mammography (CEM) capabilities designed to support breast imaging and diagnostic workflows.
“With over 30 years of experience in imaging development, it’s fair to say that it’s in our DNA, and we are strongly committed to improving the early detection of breast cancer,” says Jan Moed, managing director of Planmed Oy, in a release. “Planmed Clarity+ is the newest addition to the renowned Planmed mammography family and represents the third generation of our digital mammography systems.”
The system is designed to provide high-resolution imaging, ergonomic patient positioning, and workflow optimization features. The contrast-enhanced imaging option allows for diagnostic workup capabilities beyond standard mammography screening.
“With Planmed Clarity+, we introduce advanced features, such as contrast-enhanced mammography, to support the evolving needs of breast imaging and diagnostics,” says Moed in a release. “Our mission is to provide solutions to confidently guide the clinical pathway from screening to diagnostics.”
System Features and Market Impact
The Clarity+ product line includes high-resolution imaging capabilities, ergonomic design elements for patient comfort, and smart workflow solutions for healthcare professionals. The system’s contrast-enhanced imaging option provides additional diagnostic capabilities for clinicians evaluating breast abnormalities.
The CE MDR certification requires medical device manufacturers to demonstrate compliance with updated European Union safety and performance requirements that took effect in 2021, replacing the previous Medical Device Directive framework.
Planmed positions the system as supporting earlier and more reliable breast cancer detection through its imaging capabilities and workflow features designed for both screening and diagnostic applications.
Photo caption: Clarity+
Photo credit: Planmed
