CE Mark for Planmed Clarity 3D, DBT System

The Planmed Clarity™ 3D digital breast tomosynthesis system and the Planmed Clarity™ 2D full field digital mammography system have received the CE mark and are now available for sale in the EU and other countries where the CE mark applies. The systems have also won the prestigious Red Dot Design Award.


Finnish based device company Planmed Oy develops, manufactures and markets advanced imaging equipment and accessories for mammography and orthopedic imaging. The company’s extensive mammography product range covers digital and analog units and digital breast tomosynthesis (DBT) systems, stereotactic biopsy devices, and breast positioning systems for an early detection of breast cancer. Digital breast tomosynthesis produces a 3D volume of the breast and resolves the challenge of overlapping tissue structures, resulting in enhanced diagnostics, especially for patients with denser breast tissue.

Planmed’s patented new tomosynthesis method claims significantly improved image accuracy and allows even the smallest details to be captured with great precision.

In addition to the Planmed Clarity 3D digital breast tomosynthesis system, the new product family also includes the Planmed Clarity 2D digital mammography system, which can be easily upgraded to digital breast tomosynthesis at any time. Both systems allow imaging with a low effective patient dose and feature a durable digital detector for mobile screenings, as well as the new Planmed Clarity™ Flow touch control with dual touchscreens.

Both systems promise outstanding image quality and enable a fast and reliable workflow in all situations – from screenings to diagnostic imaging and biopsy procedures. A positive patient experience is also one of Planmed’s guiding design principles. ”We can reduce patient anxiety with the design of the systems and consequently encourage more women to participate in breast cancer screenings”, Moed concludes.

Company comments 

“We are very excited about the CE clearance, as it permits us to launch a new and improved method to combat breast cancer. The Red Dot Design Award is a further testament to our dedication and hard work”, states Jan Moed, Managing Director of Planmed. 

“We are convinced that both systems will be well accepted. The Red Dot jury especially valued their eye-catching and functional design, which also enhances ergonomics. The adaptive touch control of the systems will provide an unforeseen user experience.”

Source: Planmed Oy

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