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OMNISENSE 7000S/8000S
Reasons why Omnisense is superior to calcaneal ultrasound
The Sunlight Omnisense™ 7000S is the first and only non-radiation based device approved by the Food and Drug Administration (FDA) for monitoring both female and male bone strength changes at multiple sites. Two points are critical here. First, the "monitoring" indication by the FDA is huge; monitoring gives you the capability to track over time the efficacy of a specific bone strengthening prescription on one comprehensive report. This designation was given to the Omnisense in great part due to our ability to reproduce (i.e., precision) a valid result. Clinical studies confirm the Omnisense's high precision level of 0.6%. Calcaneal ultrasound units have precision levels of 2.5-3.0%. This translates to approximately four to five times the opportunity for an erroneous measurement.
Additionally, heel units typically are characterized as "screening" devices, a distinction well below that of "monitoring." Screening units provide you with some sense of what may or may not be happening within the bone and are most definitely not indicated for monitoring changes in bone strength. Simply put, you can screen with a monitoring approved device, but you cannot monitor with a screening device.
And second, multi-site capability (i.e., radius and phalanx (the fifth metatarsal was also part of the FDA approval in June of 2001)) gives the physician improved diagnostic accuracy when an assessment is based on a speed of sound (SOS) measurement. This convention is well supported by two independently published articles in peer review medical journals. Furthermore, the ability to look at multiple sites is very much in line with the central DXA philosophy of measuring both hip and spine. Osteoporosis is a systemic disease and thus travels through different bones at different rates. Again, the physician has the opportunity to make a decision based upon multiple site, and not single site, information.
From a competitive selling standpoint, heel units have offered far more sizzle than steak. Their approach has followed this line of thought: they tout the merits of measuring weight bearing bone in an attempt to mimic the central DXA convention of measuring hip and spine bone. Yet they overlook two key components.
First, they control rather poorly for the effect and impact of soft tissue (i.e., edema at the ankle) since they measure through the bone versus the patented Omnisense convention of measuring along the bone. Thus, a heel unit may yield two very different results depending upon the time of day the measurement is done. And second, since the heel is composed primarily of trabecular bone, its rate of re-generation is especially high given the impact nature of walking. This may be the last skeletal site we would want to measure as an indication of bone loss and fracture risk in other bony structures.
All in all, your decision to incorporate the Omnisense 7000S within your product line is sound for a multitude of reasons. I hope you find this helpful; please feel free to call or reply with any further thoughts or questions you or your associates may have.
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