Planmed submits PMA application to FDA for Full Field Digital Mammography System
Planmed is pleased to announce that the company has recently submitted a premarket approval (PMA) application to the Food and Drug Administration (FDA) for the company’s Planmed Nuance* Full Field Digital Mammography System. Planmed hopes to receive the application approval before the end of the year.
The Planmed Nuance brings digital imaging performance to a product line that is already well known for exquisite design and user ergonomics. “Medical facilities in Europe and Asia are already benefiting from the digital Nuance system”, says Mr Vesa Mattila, Vice President of Planmed Oy. “With the results of the DMIST trial, it is extremely important that we are able to provide this same innovative technology for the women in the United States.”
The Planmed Nuance is based on amorphous selenium (a-Se) detector technology. Planmed plans to offer two detector sizes. Customers may choose either the 17 cm x 23.9 cm Bucky or the optional 23.9 cm x 30.5 cm Bucky which will accommodate most patients. The Nuance unit will also be equipped with the integrated MaxView Breast Positioning device, which provides more chest wall tissue on imaging exams.
For further information, please contact:
Mr Chris Oldham, Director of Sales, Planmed, Inc.
Tel. (630) 235 4389 email@example.com
Mr Vesa Mattila,Vice President, Planmed Oy
Tel. +358 20 7795 301 firstname.lastname@example.org
About Planmed, Inc., Planmed Oy and the Planmeca Group
Planmed, Inc. of Roselle, Illinois is a division of the Planmeca Group of Helsinki, Finland. Planmed Oy develops manufactures and markets advanced imaging equipment and accessories allowing early detection of breast cancer. The product range covers digital and analog mammography units, mobile mammography units, stereotactic biopsy devices and breast positioning systems.
Planmed Oy exports more than 98% of its mammography equipment to over 70 countries worldwide. The principal markets are Europe, Japan, 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 products for the medical and the dental field. The Group currently employs over 1,900 people worldwide and the Group estimated turnover for the year 2006 is approximately 470 million euros.
* Planmed Nuance FFDM System requires FDA approval and is not currently available for sale in the USA.
- Contact Information
- Mr. Chris Oldham
- Director Of Sales
- Planmed Inc/PlanmedOY
- Contact via E-mail
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