Norland's Low Cost Strategy
In osteoporosis, low cost testing means more widespread testing. More osteoporosis is discovered, and more drugs prescribed for treatment. Norland seeks to capitalize on the opportunity in low-cost testing.
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Hologic is garnering more attention these days than it might have in the past because it's just come off an "annus mirabilis." In 2006, Hologic made three vertical acquisitions in the area of breast cancer detection, and it reported stellar financial results. The company is now a market leader in osteoporosis assessment and has an approxmately 50% share of the conventional mammography customer base as well as an early lead in digital mammgoraphy, which is remarkable considering that it is a mid-sized company competing in capital equipment markets against the likes of GE and Siemens.
Imatron's electron beam tomography, or EBT, offers clinicians a valuable tool to detect the early presence of heart disease, by looking for calcium deposits that are a surrogate for plaque build-up, and to help them begin treatment or lifestyle changes before heart attacks occur. But adoption or acceptance of EBT has been slow in coming, the result of physician skepticism, consumer ignorance, and most importantly, insurer resistance. Some physicians are skeptical because EBT measures neither restenosis no so-called vulnerable plaque. Things are looking up for Imatron, however. Sales of EBT systems are increasing rapidly due to greater acceptance in the medical community and the launch of the company's own sales force.
There could be 28 notified body designations in total under the Medical Device Regulation by the end of 2021. But there is cause for concern over designations under the IVD Regulation, which are lagging far behind.