Osteomed Enterprise - Frequently Asked Questions

Listed on this page are some of the most frequently asked questions about our products and technology. Please review them .

1. What is being measured with Omnisense?

Omnisense measures Speed of Sound (SOS) expressed as meters per second. SOS is the most appropriate technology to measure bone strength since multiple bone properties - microstructure, elasticity, cortical thickness, and bone density - are accounted for in the result. DXA measurements are based on bone mineral density only.

2. What is Omnipath^TM axial transmission technology?

Sunlight’s patented axial transmission technology, Omnipath™, is based on the measurement of the speed of ultrasonic waves (SOS) propagating along the bone. Omnipath™ enables measurement along the bone’s maximal strength axis, eliminating soft tissue effects and providing a more accurate measurement.

3. How precise is Omnisense?

Omnisense precision is 0.4% at the radius, one of the highest precision ratings in the industry. Precision is important because it gives the system the ability to monitor bone changes due to aging, treatment and other disorders.
Based on Omnisense’s high precision levels, the FDA approved the Omnisense indication for use in monitoring bone changes in the relevant age groups (50-65, peri- and post-menopause).

4. Does Omnisense comply with WHO diagnosis criteria?

Yes, Omnisense is WHO compliant. The Omnisense reference database has the same osteoporosis prevalence as Spine and Forearm DXA crossing the -2.5 diagnosis line at approximately 75 years of age.

5. Can Omnisense be used to monitor patients?

Yes, Omnisense’s measurement at any of the skeletal sites can be used for monitoring bone changes resulting from treatment. Omnisense measurement results will show changes following positive intervention (such as weight-bearing physical activity and treatment with bone formatting agents) or bone-debilitating treatments (such as steroids). While changes in the bone caused by aging can be observed only after two or three years, Omnisense can measure changes resulting from treatment after shorter time spans.

6. Does Omnisense require connection to an external computer for user interface or any other purpose?

No, Omnisense is purchased as a self-contained unit, which includes a computer, monitor, and probes. It does not require connection to an external
computer for operation. The self-contained full-size monitor provides a full-color, user-friendly graphic user interface for the user's convenience, with extended data management capabilities and full-color graphic display of results and patient history.

7. Does Omnisense have imaging capabilities?

Imaging capabilities implemented by both DXA and some ultrasound devices were developed in order to more precisely locate the region of interest (ROI), and are not intended for diagnostic use. Since Omnisense methodology is inherently reproducible with a very high precision level, imaging for this purpose would be redundant.

8. Does an Omnisense operator require any advanced training or certification?

Omnisense is easy to operate, and a person with no prior experience can expect to master its use within a few hours.

9. Does the Omnisense need calibration?

Omnisense is a completely stable system . It is calibrated in the factory and does not need any on-site recalibration procedures.

10. Why does Omnisense measure the non-dominant limb ?

As part of the Omnisense methodology, it is important that each measurement takes place on the same limb and on the same place. To facilitate this, Sunlight instituted the practice of measuring the non-dominant limb in order to avoid any confusion.

11. Can Omnisense monitor treatment like DXA?

Yes, even more effective than DXA.

12. What are the advantages Omnisense provides for long term monitoring ? What is the precision of Omnisense at the Radius?

Omnisense offers the highest precision when compared with any other devices (DXA or QUS) . Based upon Omnisense's high precision in the measurement of annual bone change , the FDA approved the Omnisense indication for use in monitoring bone changes in relevant age groups (50 - 65, peri and post-menopause). The precision (CV) ranges between 0.4 to 0.8% , dependent on skeletal site.

13. What are the advantages of Omnisense over Peripheral DEXA ?

High vs. Low Precision ; Better Monitoring Capability ; Radiation Free

14. To what depth in the bone does the ultrasound wave penetrate at the 4 measured sites , and what is the central measurement frequency ?

The wave travels at approximately 3 mm of bone depth. The central frequency is 1.25 MHz , independent of probe size.

15. Can we apply WHO criteria to Omnisense results ?

Yes, the same prevalence of Osteoporosis is found with Spine Dexa , forearm Dexa, and Radius Omnisense.

16. What parameter is more informative : SOS or BMD ?

SOS is more informative because it depends upon elasticity and micro-architecture, as well as on density and cortical thickness.;