The Planmed Nuance™ Excel full-field digital mammography (FFDM) system of Finnish Planmed Oy passes the acknowledged EUREF type testing. This type test is EU-wide tangible and demonstrable recognition of adherence to a recognized quality system. It takes into account the special requirements of both symptomatic and screening services.
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 highly appreciate this certification that proves that Planmed Nuance Excel meets acceptability criteria of the European Protocol. In addition, it provides best guidance in terms of dose and clinical image quality,” says Mr Vesa 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 mammography units are used around the world. “Only a few devices have received this clearance. Passing the EUREF type testing is recognized all over the world, and especially in Europe it is sought after. Passing the type testing means that our Planmed Nuance Excel is a technically and clinically advanced and high-quality device,” says Dr Mari Varjonen, Clinical Research Manager with Planmed Oy.
Planmed Nuance Excel is FDA approved and has the CE mark. Planmed Nuance Excel full-field digital mammography system will be on display at various exhibitions this fall, e.g. the Radiology Society of North America (RSNA) meeting starting on November 25, 2012 in Chicago.
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 and Latin America where 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 2012 is MEUR 750.
European Reference Organisation for Quality Assured Breast Screening and Diagnostic Services (EUREF)
EUREF is a pan European organisation, widely drawn from different Member States and operated on a non-profit making basis. The goal is to promote high quality mamma-care in Europe. EUREF commits itself to the development and dissemination of the European Guidelines, Certification of breast services and mammography equipment, Training and provides support and advice on such issues upon request.
EUREF has standardised type testing for mammography systems at the European level. EUREF type testing is defined as a test to verify whether a type of system is able to pass the acceptability criteria of the European protocol, and to provide guidelines about the best practice in terms of dose and (clinical) image quality. EUREF type tests are currently performed on digital mammography units (DR and CR systems). This certification allows tangible and demonstrable recognition of adherence to a recognised quality system and will take into account the special requirements of both symptomatic and screening services.