Hologic’s Selenia Awarded
In a major achievement, Hologic (NASDAQ:HOLX) won a gold Medical Design Excellence Award (MDEA) award for its Selenia Dimensions 2D/3D mammography system. MDEA, organized by the leading business-to-business media company UBM Canon, is a premier awards program that recognizes the achievements of medical devices manufacturers.
In the past, Hologic has received the gold MDEA award thrice – the Sentinelle Vanguard breast imaging and interventional coil in 2010, ThinPrep imaging system in 2004 and MammoSite radiation therapy system in 2003.
In February 2011, Hologic received approval from the US Food and Drug Administration (FDA) for its Selenia Dimensions three-dimensional (3D) digital mammography tomosynthesis system. Selenia has been developed on the Dimensions platform utilizing tomosynthesis technology to produce both 3D and the conventional two dimensional (2D) full field digital mammography (FFDM) images. The images can be used to screen and diagnose breast cancer. The product is already approved for providing 2D images. The Dimensions platform had received CE mark approval in Europe in fiscal 2008 and Canadian registration in March 2009, both for 2D and 3D modes of imaging.
Although a patient’s exposure to radiation would increase, the accuracy of detection of the disease is better with a combination of both 2-D and 3-D images. Following its approval, the product was immediately launched in the US. There are 12,000 mammography systems running in US consisting of 9,000 digital and 3,000 analog. Since approval, the company has upgraded a number of domestic systems and is pleased with the early uptake so far although adoption of the product will come about gradually. Consequently, a rapid ramp up in system sales is not expected this year.
Approval of the product will be of great help to the huge patient population. It is estimated that more than 40,000 women in America died from breast cancer in 2009. The stage at which the cancer is detected is significant as it is the right time to take medical recourse to increase woman’s survival.
With a wide range of products, Hologic has become an industry giant in the field of women’s health products. Although the Diagnostics segment has been suffering for the past few quarters due to lower doctor visits owing to economic uncertainty, the situation is gradually stabilizing. Moreover, the company is also undertaking several steps, including acquisitions, international expansion and product development to bolster its top line.
In the past, Hologic has received the gold MDEA award thrice – the Sentinelle Vanguard breast imaging and interventional coil in 2010, ThinPrep imaging system in 2004 and MammoSite radiation therapy system in 2003.
In February 2011, Hologic received approval from the US Food and Drug Administration (FDA) for its Selenia Dimensions three-dimensional (3D) digital mammography tomosynthesis system. Selenia has been developed on the Dimensions platform utilizing tomosynthesis technology to produce both 3D and the conventional two dimensional (2D) full field digital mammography (FFDM) images. The images can be used to screen and diagnose breast cancer. The product is already approved for providing 2D images. The Dimensions platform had received CE mark approval in Europe in fiscal 2008 and Canadian registration in March 2009, both for 2D and 3D modes of imaging.
Although a patient’s exposure to radiation would increase, the accuracy of detection of the disease is better with a combination of both 2-D and 3-D images. Following its approval, the product was immediately launched in the US. There are 12,000 mammography systems running in US consisting of 9,000 digital and 3,000 analog. Since approval, the company has upgraded a number of domestic systems and is pleased with the early uptake so far although adoption of the product will come about gradually. Consequently, a rapid ramp up in system sales is not expected this year.
Approval of the product will be of great help to the huge patient population. It is estimated that more than 40,000 women in America died from breast cancer in 2009. The stage at which the cancer is detected is significant as it is the right time to take medical recourse to increase woman’s survival.
With a wide range of products, Hologic has become an industry giant in the field of women’s health products. Although the Diagnostics segment has been suffering for the past few quarters due to lower doctor visits owing to economic uncertainty, the situation is gradually stabilizing. Moreover, the company is also undertaking several steps, including acquisitions, international expansion and product development to bolster its top line.
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