FDA clearance for Planmed Nuance Excel Full-Field Digital Mammography (FFDM) system

On September 23, 2011 the U.S. Food and Drug Administration (FDA) issued 510(k) approval letter for the Planmed Nuance Excel full-field digital mammography system.

Planmed Nuance Excel FFDM System combines fast examination time, low radiation dose, and outstanding image quality. The system includes Planmed’s proprietary MaxView Breast Positioning System for enhanced tissue visibility, and Side Access patient positioning for optimal working ergonomics.

“We are excited that we can now provide our unique, innovative digital mammography solutions also for women in theU.S., contributing to the fight against breast cancer. We are confident that our patient-centered design will be well received and will encourage more women to participate in breast cancer screening,” saysVesa Mattila, Vice President of Planmed Oy.

Planmed’s products are well known for their exquisite design and user ergonomics. The Planmed Nuance Excel features a large 24x31 cm amorphous selenium (a-Se) detector. It is intended for both screening and diagnostic mammography.

Planmed’s analog mammography units are widely used in theU.S.and supported by Planmed’s subsidiary Planmed, Inc. located inRoselle,Illinois. “We are very pleased to extend our mammography equipment line to also cover full-field digital mammography. Many of our customers have been looking forward to this clearance,” says Chris Oldham, Director of Sales of Planmed, Inc.

Planmed Nuance Excel full-field digital mammography system will be on display at the Radiology Society of North America (RSNA) meeting starting on November 27, 2011 in Chicago.

For further information, please contact:

Mr Vesa Mattila                                                                                    Mr Chris Oldham

Vice President, Planmed Oy                                                              Director of Sales, Planmed, Inc.

Tel. +358 20 7795 301                                                                       Tel. (630) 235 4389

vesa.mattila@planmed.com                                                              chris.oldham@planmedusa.com



Planmed Oy and the Planmeca Group

Planmed Oy develops, manufactures, and markets advanced imaging equipment and accessories for mammography and orthopedic imaging. Planmed's extensive mammography product range covers digital and analog units, stereotactic biopsy devices, and breast positioning systems for an early detection of breast cancer. Within orthopedic 3D imaging Planmed offers low dose extremity CT imaging for quicker, easier and more accurate diagnosis at the Point-of-Care.

Planmed Oy exports more than 98% of its production to over 70 countries worldwide. The principal markets are Europe,Japan, and Oceania as well as North andLatin Americawhere the company has considerable market shares. Planmed Oy is part of the Finland-based Planmeca Group which manufactures and markets advanced equipment for medical and dental fields. The Group employs approximately 2,400 professionals and the estimated turnover for the year 2011 is MEUR 700.

About Us

Better care through innovation Planmeca Group is one of the leaders in health care technology. We are dedicated to better patient care through groundbreaking health care solutions that improve the daily workflow of dental and medical professionals around the world. We manufacture and supply high-technology dental care equipment, CAD/CAM solutions, medical and dental 2D and 3D imaging devices and software, mammography systems, instruments, as well as dental supplies and services. Planmeca Group operates in over 120 countries, employing 2,700 people worldwide. Our headquarters and production facilities are located in Helsinki, Finland, where we design and manufacture our world-leading solutions, all under one roof. Over 98% of our products are exported around the world. The Group's turnover in 2014 was MEUR 740.




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