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UltraScan 650

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UltraScan 650
UltraScan™ 650 Ultrasound Bone Densitometer

The Only FDA-Approved Bone Densitometer To Measure BMD

The UltraScan™ 650 is the first and only FDA-approved bone densitometer that measures bone mineral density (BMD), the most important factor in determining the risk of osteoporotic fracture. Conventional bone sonometers measure parameters like SOS and/or BUA. These parameters have poor correlation with BMD, usually less than 0.8, and thus these devices perform poorly in terms of identifying those individuals with osteoporosis.  

By contrast, the UltraScan™ 650 uses novel patented net time delay (NTD) technology which allows measurement of the quantity of bone, which in turn provides a direct evaluation of BMD; thus the UltraScan™ 650 is a true “ultrasound bone densitometer”. Clinical studies on the UltraScan™ 650 show that its output, BMDUS, is highly correlated (r = 0.931) with x-ray based (DXA) measures of BMD. BMDDXA has‒‒until now that is‒‒been the “gold standard” for bone assessment. Now, with the availability of the UltraScan™ 650, BMD can be measured without the need for DXA, without the ionizing radiation of x-rays, at lower cost and in less time (only 10 seconds).  

Download a brochure on the UltraScan™ 650, see an ad for the UltraScan™ 650 that has appeared in both Journal for Bone and Mineral Research and Osteoporosis International, watch a 15-second video of a BMD test with the UltraScan™ 650, and contact us for more information or to place an order for an UltraScan™ 650, the next generation ultrasound bone densitometer. 

*It should be noted that the correlation of forearm BMD values as determined by DXA machines from different manufacturers is usually in the range of 0.8 to 0.95. 

 

UltraScan 650

Benefits of UltraScan™ 650

Accurate & Reliable
The UltraScan™ 650 bone densitometer provides osteoporotic fracture risk assessment with the same discriminating ability as DXA. It measures bone mineral density (BMD) with a correlation of 0.93 and a precision of 2%, offering results equivalent to those produced by a DXA machine. The report includes BMD in grams/cm², T-scores, and Z-scores, making the UltraScan™ 650 bone densitometer an ideal tool for clinically diagnosing and managing osteoporosis.
Fast & Easy
The UltraScan™ 650 bone densitometer offers a quick and comfortable exam, with BMD assessment taking just 10 seconds. All your patients need to do is roll up their sleeves—no foot required. It does not involve any user interactions with data processing, and there's no need for messy gel or exposure to ionizing radiation.
Convenient
The UltraScan™ 650 bone densitometer is portable, weighing less than 8 pounds, USB/battery-powered (no outlet needed!), and affordable, with a compact 10 x 15-inch desktop footprint that fits any office. Its 10-second exam time allows for high patient throughput, with no need for a shielded room and no formal certification required for the operator. Results are concise and can be conveniently printed or emailed at the time of the exam, with an easily interpreted report.

Innovations Behind the Technological and Clinical Advantages of the UltraScan™ 650 Bone Densitometer

The UltraScan 650 Bone Densitometer will expand access to bone assessment and significantly decrease the under-diagnosis of osteoporosis. Clinical studies show the correlation between BMD of a DXA and UltraScan 650 is 0.93. The portability and simplicity in use of the radiation-free ultrasound scanner, combined with its high degree of accuracy and precision in measuring radial BMD, provides a basis by which to expand ultrasonic assessment to the primary care setting. This will in turn provide an opportunity to reduce the incidence of osteoporotic fractures through early and timely therapeutic interventions, and thereby reduce the degree of associated morbidity and mortality.

Net Time Delay (NTD) Technology

UltraScan™ 650 Bone Densitometer relies on CyberLogic’s patented NTD technology. The NTD is based on measuring transit times of ultrasound signals propagating through the forearm, which allows direct measurement of the amount of bone. 

1/3 RADIUS

The UltraScan™ 650 bone densitometer utilizes the 1/3 radius of the forearm, a critical site for evaluating bone mineral density (BMD) since it is rich in cortical bone and more resistant to fractures than other bone types. 

Forearm Positioning Technolgy

The UltraScan 650 Bone Densitometer incorporates patented positioning technology, which makes for both reproducible and accurate measurement of bone mineral density (BMD) at the 1/3 radius. 

UltraScan 650 BMDUS™ Technology

The UltraScan 650 Bone Densitometer is an ultrasound device that is designed to non-invasively and quantitatively assess the amount of bone at the 1/3 location of the radius in the forearm of an individual. 

Net Time Delay (NTD) Technology

UltraScan™ 650 relies on CyberLogic’s patented NTD technology. The NTD is based on measuring transit times of ultrasound signals propagating through the forearm, which allows direct measurement of the amount of bone. The NTD has been validated with computer simulations, in vitro studies, and clinical data, and represents a completely distinct approach to processing of ultrasound data. Conventional bone sonometers evaluate the speed of sound (SOS) and broadband ultrasound attenuation (BUA); these parameters are only weakly correlated with bone mineral density (BMD). In contrast, the high degree of correlation (r = 0.93) of the UltraScan 650 output with BMD is due to the use of the NTD technology. A number of papers and patents related to the NTD technology can be found in the References. Specifically, a summary of the key clinical data can be found in: (A comprehensive paper summarizing the performance of the UltraScan 650 in a clinical trial can be found in our publication by Stein et al. in Ultrasound in Medicine & Biology.) The simulation and in vitro data can be found, respectfully, at: “Ultrasound Simulation in Bone” and “Ultrasonic Assessment of the Radius in vitro”.

1/3 RADIUS

The UltraScan 650 utilizes the 1/3 radius for determination of BMD. The 1/3 radius has been used for over 5 decades by x-ray methods (SPA, DPA, SXA, DXA) and is well-established as a useful anatomical site for bone assessment and osteoporotic fracture risk determination. It is also an extremely convenient site, and generally requires nothing more than rolling up one’s sleeve. The figure shows the two bones of the forearm (radius and ulna) as well as the cross section of the radius. Note that the UltraScan 650 is the only through-transmission ultrasound device approved in the U.S. for measurement at the 1/3 radius, and the only one approved by the FDA for measurement of BMD.

forearmdevice radius

FOREARM POSITIONING TECHNOLGY

The UltraScan 650 incorporates patented positioning technology, which makes for both reproducible and accurate measurement of BMD at the 1/3 radius. Whereas conventional ultrasound measurements of the heel lead to great variations in results because of the difficulty in re-positioning, the UltraScan 650 can be respositioned extremely accurately. In addition, standard DXA requires significant technician interaction in terms of processing the data; in contrast, the UltraScan 650 does not require nor does it permit any user interactions with data processing.

UltraScan 650 BMDUS™ Technology

Device Description:

The UltraScan 650 is an ultrasound device that is designed to non-invasively and quantitatively assess the amount of bone at the 1/3 location of the radius in the forearm of an individual. The UltraScan 650, with a user-supplied laptop, is designed for the measurement of bone mineral density (BMD in g/cm2) of the radius at the 1/3 location. The UltraScan 650 outputs BMDUS which is a measurement of the BMD that would be measured by dual-energy X-ray absorptiometry (DXA) at the same anatomical location, that is, a measurement of BMDDXA, at the 1/3 radius. The UltraScan 650 also outputs the T-score in standard deviations (SD) and z-score in SD as well. The precision of the measurement is 2.1%, when expressed as a coefficient of variation.

FDA-approved Indications for Use

  1. UltraScan 650 can be used to determine BMDUS Index in adult men and women and to assess appendicular fracture risk in postmenopausal women.
  2. The BMDUS Index is a clinical measure based on ultrasound variables of the forearm which is highly correlated with the value of BMD of the 1/3 radius as provided by DXA, with a standard error of the measurement of 0.041 grams/cm2.
  3. BMDUS Index is expressed in grams/cm2 and as a T- and z-score, derived from comparison to a normative x-ray absorptiometry reference database.
  4. BMDUS Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in postmenopausal women.
  5. The UltraScan™ 650 is a through-transmission system and is designed to measure the radius at the 1/3rd location (shown as the radius and ulna and the cross-section of the radius in the pictures above), a site that has been measured for decades with x-ray densitometers.

References

Net Time Delay Technology
Simulation
In Vitro
Forearm Positioning
Clinical
Bone Assessment - General
Peripheral Densitometry

Net Time Delay Technology:

Luo GM and Kaufman JJ “Ultrasonic Bone Assessment Apparatus and Method” China Patent Number CN102186422A, Issued June 12, 2013. (Cover page only; please contact us for the full version)

Luo GM and Kaufman JJ “Ultrasonic Bone Assessment Apparatus and Method” India Patent Number 250523, Issued January 9, 2012.

Luo GM and Kaufman JJ “Ultrasonic Bone Assessment Apparatus and Method” United States Patent Number 8,202,219, Issued June 19, 2012.

Luo GM and Kaufman JJ “Ultrasonic Bone Assessment Apparatus and Method” China Patent Number CN 101199429A, Issued June 06, 2012. (Cover page only; please contact us for the full version)

Luo GM and Kaufman JJ “Ultrasonic Bone Assessment Apparatus and Method” United States Patent Number 7,862,510, Issued January 4, 2011.

Luo GM and Kaufman JJ “Ultrasonic Bone Assessment Apparatus and Method” United States Patent Number 7,901,356, Issued March 8, 2011.

Luo GM and Kaufman JJ “Ultrasonic Bone Assessment Apparatus and Method” China Patent Number CN1243981 B, Issued April 13, 2011 (Cover page only; please contact us for the full version)

Luo GM, Siffert RS, Johnson WA, Altman RL and Kaufman JJ “Ultrasonic Bone Assessment Apparatus and Method” China Patent Number CN 1732853 B, Issued September 22, 2010 (Cover page only; please contact us for the full version)

Luo GM and Kaufman JJ “Ultrasonic Bone Assessment Apparatus and Method” Hong Kong Special Administrative Region Patent Number 1123474, Issued February 4, 2008.

Kaufman JJ, Luo GM, Siffert RS. “A Portable Real-Time Bone Densitometer,” Ultrasound in Medicine and Biology, 2007; Sep;33(9):1445-52.

Simulation:

Kaufman JJ, Luo GM, Siffert RS. 3D Simulation of Ultrasound in the Ultra-distal Human Radius, in Acoustical Imaging, Volume 31, Nowicki A, Litniewski J, Kujawska T, Eds., 2012, Springer:New York, pp. 39-43.

Le Floch V, McMahon DJ, Luo GM, Cohen A, Kaufman JJ, Shane E, Siffert RS. Ultrasound Simulation in the Distal Radius Using Clinical High-Resolution Peripheral-CT Images.Ultrasound in Medicine and Biology, 2008; 34.

Kaufman JJ, Luo GM, Siffert RS. Ultrasound Simulation in Bone (Invited Paper). IEEE Transactions Ultrasonics, Ferroelectrics and Frequency Control, 2008; 56(6):1205-1218.

Kaufman JJ, Luo GM, Siffert RS, “Simulation of Ultrasound Propagation in Bone,” JASA, Vol. 116, No. 4, Pt. 2 of 2, pp. 2476-2477, 2004.

Kaufman JJ, Luo GM, Siffert RS, “Simulation of Ultrasound Propagation in Bone,” (Invited) JASA, Vol. 116, No. 4, Pt. 2 of 2, pp. 2476-2477, 2004.

Kaufman JJ, Luo GM, Siffert RS, “On the Relative Contributions of Absorption and Scattering to Ultrasound Attenuation in Trabecular Bone: A Simulation Study,” Proceedings 2003 IEEE International Ultrasonics Symposium, pp. 1519-1523, 2003.

Kaufman JJ, Luo GM, Siffert RS, “Ultrasound Simulation for 3D-Axisymmetric Models,” Proceedings 2003 IEEE International Ultrasonics Symposium, pp. 2065-2068, 2003.

Akkus O, Nasser PR, Kaufman JJ, Jepsen KJ, “Simulation of Ultrasonic Wave Propagation in Damaged Cortical Bone,” Transactions 2001 Summer Bioengineering Conference, ASME, 2001.

Luo GM, Kaufman JJ, Chiabrera A, Bianco B, Kinney JH, Haupt D, Ryaby JT and RS Siffert, “Computational methods for ultrasonic bone assessment,” Ultrasound in Medicine and Biology, Vol. 25(5):823-830, 1999.

Clinical

FDA approval letter

Nagaki GM, Luo GM, Kaufman JJ, Rosenbaum A, Riffert RS. 2015 The Axial Dependence of Bone Density and Ultrasound at the Radius, presented (Poster No. 0593) at the 2015 Annual Meeting of the Orthopedic Research Society in Las Vegas, NV.

Kaufman JJ, Luo GM, Rosete F, Bucovsky M, Stein EM, Shane E, Siffert RS. 2014 Ultrasonic Assessment of the Radius (Invited Paper), in Proceedings IFMBE, 2014, VV Toi, THL Phuong, eds., Vietnam National Universities, Ho Chi Minh City, Vietnam, pp. 77-79.

Stein E, Rosete F, Luo GM, Bucovsky M,Kaufman JJ, Shane E, Sifffert. 2014 Clinical Ultrasonic Bone Assessment of the 1/3 Radius, presented at the ASBMR 2014 Annual Meeting in Houston, TX.

Kaufman JJ, Stein E, Luo GM,Rosette F, Schechner Z, Bucovsky M, Shane E, Siffert RS (2014) Clinical Ultrasonic Assessment at the 1/3 Radius, presented at the 2014 IEEE International Ultrasonics Symposium, Chicago, Il.

EM Stein, F Rosete, P Young, M Kamanda-Kosseh, DJ McMahon, GM Luo, JJ Kaufman, E Shane, RS Siffert. Clinical assessment of the 1/3 radius using a new desktop ultrasonic bone densitometer. Ultrasound in Medicine and Biology, 2013, Vol. 39, No. 3, pp. 388–395.

Nagaki GM, M Lieberman, GM Luo, JJ Kaufman, S Rosenfeld, A Rosenbaum and RS Siffert. “Ultrasonic Assessment of the Forearm”, Presented at the 18th Annual Meeting of the International Society of Clinical Densitometry, Los Angeles, CA, March 7-10, 2012.

Kaufman JJ, Luo GM, Lieberman M, Rosenfeld S, Rosenbaum A, Siffert RSS. Ultrasonic Assessment of the Radius. J Bone Miner Res:25(Issue S1), S1¨CS504, 2010.

Kaufman JJ, Luo GM, Siffert RS, “Effect of Arm Dominance on Quantitative Transmission Ultrasound at the Forearm”,31st meeting of the American Society for Bone and Mineral Research, September 11-15, 2009, Denver Colorado.

Siffert RS, Kaufman JJ. “Ultrasonic Bone Assessment: ‘The Time Has Come’,” Bone, Vol. 40, pp. 5-8, 2007.

Bone Assessment - General

Luo GM and Kaufman JJ “Method and System for Bone Fracture Risk Assessment” United States Patent Number 9,532,761, Issued Jan. 3, 2017.

Krieg MA, Barkmann R, Gonnelli S, Stewart A, Bauer DC, Del Rio Barquero L, Kaufman JJ, Lorenc R, Miller PD, Olszynski WP, Poiana C, Schott AM, Lewiecki EM, Hans D. Quantitative Ultrasound in the Management of Osteoporosis: The 2007 ISCD Official Positions.Journal of Clinical Densitometry., 2008; 11(1):163-187.

Kaufman JJ and Siffert RS, “Non-invasive Assessment of Bone Integrity,” in Bone Mechanics Handbook, Cowin S, Ed, CRC Press, Boca Raton, Chapter 34, pp. 34.1-34.25, 2001.

Chiabrera AE and Kaufman JJ “Ultrasonic Bone Assessment Method and Apparatus” United States Patent Number 5,879,301, Issued March 9, 1999.

Chiabrera AE and Kaufman JJ “Ultrasonic Bone Assessment Method and Apparatus” United States Patent Number 5,785,656, Issued July 28,1998.

Kaufman JJ and Chiabrera AE “Ultrasonic Bone Assessment Apparatus and Method” United States Patent Number 5,651,363, Issued July 29,1997.

International Quantitative Ultrasound Consensus Group, “Quantitative ultrasound techniques for the assessment of osteoporosis: expert agreement on current status,” J Bone Min Res Vol 12(8):1280-1288, 1997.

Chiabrera A, Bianco B, Siffert and JJ Kaufman, “Ultrasound measures both bone mass and architecture: theoretical results for an idealized model of trabecular bone,” Trans 42nd Ann Mtg Orthop Res Soc, Feb.18-22, 1996, 21(2):600.

Kaufman, JJ, W Xu, AE Chiabrera and RS Siffert, “Diffraction effects in insertion mode estimation of ultrasonic group velocity,” IEEE Trans. on Ultrasonics, Ferroelectrics, and Frequency Control, Vol. 42(2), pp. 232-242, 1995.

Alves JM, Ryaby JT, Siffert RS, Magee FP and Kaufman JJ “Comparison of a contact and insertion ultrasonic assessment technique,” J Bone and Mineral Research, Vol. 10(Supp. 1), S274:S494, August 1995.

Kaufman, JJ, M Alves, RS Siffert, FP Magee and JT Ryaby “Ultrasound assessment of trabecular bone density using neural networks,” J Bone and Mineral Research, Vol. 9, Supp. 1, p. A204, August 1994.

Xu, W, RS Siffert and JJ Kaufman, “Application of wavelet analysis to ultrasonic characterization of bone,” Conference Record of the 28th Asilomar Conference on Signals, Systems, and Computers, pp. 1090-1094, 1994.

Kaufman JJ and Chiabrera AE “Ultrasonic Bone-Assessment Apparatus and Method” United States Patent Number 5,259,384, Issued November 9, 1993.

Kaufman, JJ and TE Einhorn, “Review – Ultrasound Assessment of Bone,” Journal of Bone and Mineral Research, Vol 8, Number 5, pp. 517-525, 1993.

Xu, W and JJ Kaufman, “Diffraction Correction Methods for Insertion Ultrasound Attenuation Measurement,” IEEE Transactions Biomedical Engineering, Vol. 40, No. 6, pp. 563-570, June 1993.

Lin, D, W Xu, M Klein, T Einhorn, JJ Kaufman and RS Siffert, “Effect of physical factors on ultrasound attenuation and velocity in bone,” J. Bone and Mineral Research, Vol. 8, Supp. 1, p. S319, August 1993.

Frequently Asked Questions

At CyberLogic, we understand you may have questions about our innovative technologies and research. Whether it's about our FDA-approved UltraScan™ 650 bone sonometer, our or our cutting-edge work in biomedical and electrical engineering, this FAQ section will provide answers.
What is the UltraScan™ 650, and how does it differ from traditional bone density tests?
The UltraScan™ 650 is an FDA-approved ultrasound bone sonometer that measures bone mineral density (BMD) without using ionizing radiation, unlike traditional DXA scans. It provides accurate and reproducible results, making it a safer and more convenient option for osteoporosis management.
How long does a bone density exam take with the UltraScan™ 650?
The UltraScan™ 650 performs a bone density exam in just 10 seconds, providing quick and efficient assessments without the need for messy gel or patient preparation, making it highly convenient for both patients and clinicians.
Is the UltraScan™ 650 portable and easy to use in different clinical settings?
Yes, the UltraScan™ 650 is highly portable, weighing less than 8 pounds and powered by USB or battery. Its small footprint and ease of use make it ideal for various clinical settings without requiring a dedicated space or formal operator certification.
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