CE MDR Certification Awarded to Planmed Oy’s Planmed Clarity+ Platform

Planmed Oy has earned CE MDR (Medical Device Regulation) certification for its Planmed Clarity+ mammography product line.

“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. Planmed Clarity+ is the newest addition to the Planmed mammography family and represents the third generation of our digital mammography systems,” Planmed Oy Managing Director Jan Moed stated.

The Planmed Clarity+ product line is designed to provide superior image quality, optimized workflow, and patient comfort in mammography. The platform incorporates such advanced features as:

• High-resolution imaging for accurate diagnostics
• Ergonomic design to improve patient experience
• Smart workflow solutions to support healthcare professionals
• Contrast-enhanced imaging option to allow diagnostic workup

“With Planmed Clarity+, we introduce advanced features, such as contrast-enhanced mammography (CEM), to support the evolving needs of breast imaging and diagnostics. Our mission is to provide solutions to confidently guide the clinical pathway from screening to diagnostics,” Moed continued.

Planmed Clarity+ empowers clinicians to detect breast cancer earlier and more reliably, contributing to improved patient outcomes.

“Achieving CE MDR certification for the Planmed Clarity+ product line in such a short period of time is a significant achievement for our team and a testament to our dedication to innovation and patient safety,” Planmed Oy Sales/Marketing Director Satu Seppälä noted. “We are proud to provide healthcare providers across Europe with mammography solutions that meet the highest regulatory standards.”

Planmed Oy develops and manufactures advanced imaging equipment and accessories that provide a combination of image quality and ease of use for medical imaging professionals. The company offers products for mammography and orthopedic imaging that are known for their imaging performance, user-friendliness, and ergonomics. Planmed Oy is part of the Finnish Planmeca Group, which consists of several healthcare technology brands, each committed to innovation and design. With 4,400 employees worldwide, Planmeca Group companies achieved a combined turnover of €1.2 billion in 2024.