ICUS Weekly News Monitor 11-4-2016

1.  Medical Xpress,  Nov 3, 2016,  Breast-friendly, radiation-free alternative to mammogram in the making
 
2.  BCC Research,  Nov 1, 2016,  Technology Powering Growth in Global Markets for Medical Ultrasound Devices, Reports BCC Research
 
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Medic al Xpress
Nov 3, 2016
 
Breast-friendly, radiation-free alternative to mammogram in the making
 
Each year around a million women in the Netherlands undergo mammograms for early detection of possible breast cancer. It's an unpleasant procedure that uses X-rays. Researchers at Eindhoven University of Technology are working on a 'breast-friendly' method, without radiation, that is more accurate and generates 3D rather than 2D images. They published their proof of concept last month in the online journal Scientific Reports.
 
In the regular screening method the breast is squeezed tight between two plates in order to produce one or more good X-ray photos. Apart from being unpleasant, it is not without risk. The X-rays used can themselves be a contributor to the onset of cancer. Moreover, it is often unclear whether the anomaly found is a cancer or not. More than two-thirds of the cases where something worrying can be seen on the X-ray photos is false-positive: after the analysis of biopsies they are not found to be cancers. This is why science is seeking alternatives.
 
Researchers at TU Eindhoven have now cleared a major scientific hurdle towards a new technology in which the patient lies on a table and the breast hangs freely in a bowl. Using special echography (inaudible sound waves) a 3D image of the breast is made where cancer can be identified; the researchers therefore expect there to be many fewer false-positive results.
 
The new technology builds on the patient-friendly prostate cancer detection method developed at TU/e whereby the doctor injects the patient with harmless microbubbles. An echoscanner allows these bubbles to be precisely monitored as they flow through the blood vessels of the prostate. Since tumors and healthy tissue have different blood vessel structures, the presence and location of tumors become visible. This method works well for the prostate and this is now being widely tested in hospitals in the Netherlands, China and, soon, Germany. For breast cancer the method had not yet been suitable due to motion and because the breast is too large, which seriously limits the possibilities of a standard echoscanner.
 
Researchers Libertario Demi, Ruud van Sloun and Massimo Mischi have now developed a variant of the echography method that is suitable for breast investigation. The method is known as Dynamic Contrast Specific Ultrasound Tomography. Echography with microbubbles uses the fact that the bubbles will vibrate in the blood at the same frequency as the sound produced by the echoscanner, as well as at twice that frequency; the so-called second harmonic. By capturing the vibration, you know where the bubbles are located. But body tissue also generates harmonics, and that disturbs the observation.
 
For the new method the researchers are using a phenomenon that Mischi happened upon by chance and later investigated its properties together with Demi. They saw that the second harmonic was a little delayed by the gas bubbles. The researchers have now developed a new visualization method. The more bubbles the sound-wave encounters on its route, the bigger the delay. By measuring the delay, the researchers can thus localize the gas bubbles and do so without any disturbance because the harmonic generated by the body tissue is not delayed, and is therefore discernible. This difference, however, can only be seen if the sound is captured on the other side. So this method is perfectly suited to organs that can be approached from two sides, like the breast.
 
The researchers are currently putting together an international, strong medical team to start performing preclinical studies. Application in practice is certainly ten or so years away, Mischi expects. Moreover, he forecasts that the technology that has been developed will probably not operate on a standalone basis but in combination with other methods, which will create a better visualization. One of the candidates for this elastography, a variant of echography whereby the difference in the rigidity of the tumor and healthy tissue can be used to detect cancer.
 
 
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BCC Research
Nov 1, 2016
 
Technology Powering Growth in Global Markets for Medical Ultrasound Devices, Reports BCC Research
 
Recent advancements in ultrasound technology include the wireless and immediate transmission of images using applications and dedicated cloud servers. BCC Research reveals in its new report that this trend toward inexpensive, portable, and wireless ultrasound imaging is helping move the global markets for medical ultrasound devices.
 
Diagnostic ultrasound, also called sonography or diagnostic medical sonography, is a noninvasive imaging method that utilizes high-frequency sound waves to produce images of structures within your body.
 
The global market for medical ultrasound devices is expected to reach $9.9 billion by 2021, up from $7.3 billion in 2016, reflecting a five-year compound annual growth rate (CAGR) of 6.4%. The Asia-Pacific market, the largest and fastest-growing market, should reach $2.4 billion and $3.7 billion in 2016 and 2021, respectively, demonstrating a five-year CAGR of 9.5%. The Latin American market, the second-fastest growing market with an anticipated five-year CAGR of 8%, should grow from $576 million in 2016 to $847 million in 2021.
 
Recent innovations include hand-carried ultrasound (HCU) units, advances in three-dimensional (3-D) and four-dimensional (4-D) ultrasound imaging, improvements in image quality, and the use of ultrasound contrast agents to improve sensitivity for the detection of tumors. Another key development is the emergence of sonoelastography to help diagnose liver fibrosis staging, thyroid nodules, and lymph node and indeterminate breast lump characterization.
 
Technological advances in diagnostic ultrasound imagery have significantly improved patient diagnostics by providing immediate clinical information. These rapid advances are directly related to the parallel advancements in electronics, computing and transducer technology together with sophisticated signal processing techniques. The availability of instantaneous diagnostic data has helped reduce overall healthcare costs by replacing more expensive diagnostic examinations.
 
"One of ultrasound's key advantages over other imaging modalities is its increasing mobility," says BCC Research analyst Paul Taylor. "From innovations such as portable handheld devices to the world's first wireless transducer, ultrasound can quickly image internal organs such as the heart, kidney and liver, without being impeded by cables or bulky machines. This key feature of ultrasound not only improves the point of care at hospitals, but also the public's access to medical imaging, especially in developing regions where it is needed."
Medical Ultrasound Devices: Techs and Global Markets (IAS040B) analyzes the values, growth rates, shares, dynamics, and factors of major market and submarkets. Global market drivers and trends, with data from 2015, estimates for 2016, and projections of CAGRs through 2021 also are provided.
 
Editors and reporters who wish to speak with the analyst should contact Steven Cumming at This email address is being protected from spambots. You need JavaScript enabled to view it. .
 
About BCC Research
BCC Research is a publisher of market research reports that provide organizations with intelligence to drive smart business decisions. By partnering with industry experts worldwide, BCC Research provides unbiased measurements and assessments of global markets covering major industrial and technology sectors, including emerging markets. Founded in 1971, BCC Research is a unit of Eli Global, LLC. For more information about BCC Research, please visit bccresearch.com. Follow BCC Research on Twitter at @BCCResearch.

ICUS Weekly News Monitor 10-27-2016

1.  URO Today ,  Oct 22, 2016,  Ultrasound-contrast-agent dispersion and velocity imaging for prostate cancer localization.      Authors:  Ruud Jg van Sloun, et al
 
2.  DotMed, HealthCareBusiness Daily News,  Oct 7, 2016,  GE ultrasound contrast agent Optison gets FDA OK for label change        by Thomas Dworetzky
 
 
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URO Today
Oct 22, 2016
PubMed http://www.ncbi.nlm.nih.gov/pubmed/27723564
 
Ultrasound-contrast-agent dispersion and velocity imaging for prostate cancer localization.
 
Authors:
Ruud Jg van Sloun, Libertario Demi, Arnoud W Postema, Jean Jmch de la Rosette, Hessel Wijkstra, Massimo Mischi
 
Lab. of Biomedical Diagnostics, Eindhoven University of Technology, the Netherlands. Electronic address: This email address is being protected from spambots. You need JavaScript enabled to view it. ., Lab. of Biomedical Diagnostics, Eindhoven University of Technology, the Netherlands., Academic Medical Center University Hospital, Amsterdam, the Netherlands., Lab. of Biomedical Diagnostics, Eindhoven University of Technology, the Netherlands; Academic Medical Center University Hospital, Amsterdam, the Netherland
Prostate cancer (PCa) is the second-leading cause of cancer death in men; however, reliable tools for detection and localization are still lacking. Dynamic Contrast Enhanced UltraSound (DCE-US) is a diagnostic tool that is suitable for analysis of vascularization, by imaging an intravenously injected microbubble bolus. The localization of angiogenic vascularization associated with the development of tumors is of particular interest. Recently, methods for the analysis of the bolus convective dispersion process have shown promise to localize angiogenesis. However, independent estimation of dispersion was not possible due to the ambiguity between convection and dispersion. Therefore, in this study we propose a new method that considers the vascular network as a dynamic linear system, whose impulse response can be locally identified. To this end, model-based parameter estimation is employed, that permits extraction of the apparent dispersion coefficient (D), velocity (v), and Péclet number (Pe) of the system. Clinical evaluation using data recorded from 25 patients shows that the proposed method can be applied effectively to DCE-US, and is able to locally characterize the hemodynamics, yielding promising results (receiver-operating-characteristic curve area of 0.84) for prostate cancer localization.
 
Medical image analysis. 2016 Oct 01 [Epub ahead of print]
 
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DotMed
HealthCareBusiness Daily News
Oct 7, 2016
 
GE ultrasound contrast agent Optison gets FDA OK for label change
by Thomas Dworetzky , Contributing Reporter
 
The FDA has approved a label change that allows GE Healthcare's Optison ultrasound contrast agent to be used in a larger range of cases. Specifically, it downgrades its use in patients with cardiac shunts and for administration by intra-arterial injection from a contraindication to a warning and precaution.
 
Prior to this labeling shift, to use the agent, perflutren protein-Type A microspheres injectable suspension, in suspected cardiac shunt populations, an agitated saline procedure was needed first.
 
The change makes Optison the first contrast agent for use in the U.S. to be so labelled, GE said in a statement.
 
The change has brought positive responses from a number of health care professionals, including Dr. Sharon L. Mulvagh, who is professor of medicine, director of the Women's Heart Clinic and preventive cardiology consultant in cardiovascular diseases at the Mayo Clinic and Mayo Clinic College of Medicine, GE noted.
 
“This label change will allow more patients access to a diagnostic imaging tool that has established safety and efficacy. The FDA’s decision to remove this contraindication is supported by a body of data from studies demonstrating safety and clinical benefits of all ultrasound contrast agents in patients with cardiovascular diseases,” said Mulvagh.
 
Mulvagh called the label change “an important step forward in eliminating barriers to ultrasound contrast use and delivering quality diagnostic care of value to our patients.”
 
Cardiac shunts are quite common and pose a challenge to clinicians. “Up to one-third of our patients have known or suspected cardiac shunts and, thanks to this important FDA decision, they, too, will now have access to ultrasound contrast agents, which offer an inexpensive and radiation-free option for diagnostic imaging,” noted Dr. Steven Feinstein, co-president of the International Contrast Ultrasound Society.
 
The decision came about thanks to “the overwhelming weight of evidence from clinical trials," noted Dr. Jonathan Lindner, M. Lowell Edwards Professor of Cardiology at the Knight Cardiovascular Center, Oregon Health & Science University.
 
He added that “most practitioners in the field of echocardiography already realize the benefits of using contrast agents and understand their capacity to improve diagnostic accuracy, improve outcomes, and streamline care. However, a major obstacle to widespread use has been lack of consensus and confusion regarding how far one needs to go to exclude shunts, no matter how small.”
 
The clinical advantage of appropriate use of the contrast agent was highlighted by the Head of Global Medical Services at GE Healthcare, Mark Hibberd, who added that Optison use will expand the imaging options and facilitate the care of “the clinically important group of patients who have suboptimal echocardiograms, and a need for left ventricular opacification and delineation of LV borders.”
 
The contrast market is set to surpass $6 billion by 2022, according to GlobalData research announced in April. The market was “just over $4.3 billion in 2015,” giving a compound annual growth rate of 4.9 percent.

ICUS Weekly News Monitor 10-6-2016

1.  MassDevice.com,  Oct 3, 2016,  FDA approves label changes for GE’s Optison
By Sarah Faulkner
 
2.  Aunt Minnie,  Oct 3, 2016,  Contrast US boosts diagnostic power of breast ultrasound
By Erik L. Ridley
 
3.  Journal of Ultrasound in Medicine,  Oct 1, 2016,  Diagnostic Value of Contrast-Enhanced Sonography for Differentiation of Breast Lesions;  A Meta-analysis
Authors:  Xuelei Ma, MD,  et al
 
4.  Journal of Ultrasound in Medicine,  Oct 1, 2016,  Hepatic Vein Arrival Time for Diagnosis of Liver Cirrhosis; A 10-Year Single-Center Experience With Contrast-Enhanced Sonography
Authors: Teresa Abbattista, MD, et al
 
5.  ICUS,  Oct 1, 2016,  CMS Announces Coding for liver and/or abdominal ultrasound with contrast
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*To view presentations live-streamed from the 31st Annual Advances in Contrast Ultrasound Bubble Conference held in Chicago, 8/9 September 2016, go to: www.livemedia.com/register/bubble16
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MassDevice.com
Oct 3, 2016
 
FDA approves label changes for GE’s Optison
By Sarah Faulkner
 
GGE Healthcare (NYSE:GE) announced today that the FDA approved label changes for its ultrasound contrast agent Optison, removing contraindications for use in patients with cardiac shunts and for administration by intra-arterial injection.
 
Optison is the 1st contrast agent available in the U.S. to receive this label change, according to GE.
 
“Up to one-third of our patients have known or suspected cardiac shunts and, thanks to this important FDA decision, they too will now have access to ultrasound contrast agents, which offer an inexpensive and radiation-free option for diagnostic imaging,” International Contrast Ultrasound Society co-prez Dr. Steven Feinstein said in prepared remarks. “The International Contrast Ultrasound Society applauds the FDA for its decision, and believes it will benefit individual patients as well as our healthcare delivery system,”
 
Previously, to determine if a patient was contraindicated to receive an ultrasound contrast agent, doctors used an agitated saline procedure to see if the blood flow pattern in the heart was characteristic of a cardiac shunt.
 
“We welcome this FDA decision and hope that this will allow more patients access to contrast-enhanced ultrasound procedures and improve the management of their conditions,” chief technology officer Ger Brophy added.
 
“We are extremely pleased that the FDA has changed the labeling for cardiac shunts with Optison when it is used in the clinically important group of patients who have suboptimal echocardiograms, and a need for left ventricular opacification and delineation of LV borders. Many of these patients have limited options for cardiac imaging, and the FDA’s decision will facilitate their care,” head of global medical services Mark Hibberd explained.
 
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Aunt Minnie
Oct 3, 2016
Contrast US boosts diagnostic power of breast ultrasound
By Erik L. Ridley, AuntMinnie staff writer
 
Contrast-enhanced ultrasound (CEUS) can be an effective method for the differential diagnosis of benign and malignant breast lesions, offering improvements in diagnostic accuracy over conventional breast ultrasound, according to research published in the October issue of the Journal of Ultrasound in Medicine.
 
In a meta-analysis incorporating nearly 30 studies and more than 2,000 patients, a team from Sichuan University in Chengdu, China, found that contrast-enhanced ultrasound offered a combined sensitivity of 88% and specificity of 80%. What's more, diagnostic performance also improved with the advent of second-generation contrast agents.
 
Dr. Xuelei Ma from Sichuan University.
"Contrast-enhanced sonography could be developed as a promising and effective tool for distinguishing benign from malignant breast lesions, which may be a valuable supplement to fine-needle aspiration [biopsy]," first author Dr. Xuelei Ma told AuntMinnie.com. "Meanwhile, in terms of contrast-enhanced breast sonography, the second-generation contrast agents might increase the diagnostic accuracy, and the harmonic mode might be more suitable for performance."
 
Improving accuracy?
 
Breast ultrasound has been shown to have relatively high sensitivity of approximately 90% and specificity of around 40%, according to the researchers. CEUS has been suggested as a way to improve the modality's diagnostic accuracy, but relevant studies have shown sensitivity ranging from 50% to 100% and specificity ranging from 37% to 100%.
 
"Meanwhile, the overall analysis of different types of contrast agents and contrast modes has not been assessed systematically," Ma said. "Therefore, we carried out this study to investigate the performance of contrast-enhanced sonography in the differential diagnosis of benign and malignant breast lesions."
 
The researchers searched PubMed and Embase for all relevant studies performed before January 2015. They also manually reviewed references of related articles (J Ultrasound Med, October 2016, Vol. 35:10, pp. 2,095-2,102).
 
Clinical studies were included in the meta-analysis if they met the following criteria:
They focused on the diagnostic value of contrast-enhanced sonography in breast cancer.
Histopathologic findings were used as the reference standard for lesion diagnosis.
 
They offered sufficient data to construct a table corresponding to true-positive, true-negative, false-positive, and false-negative rates.
 
The sample size must have been more than 10 patients and duplicate results needed to be eliminated.
 
The researchers did not include letters, reviews, editorials, and case reports. In cases where a study involved the same author or authors from the same medical center and had similar data and patient design, the researchers selected the article with the larger sample size. A total of 29 eligible studies satisfied the inclusion criteria and included an aggregate of 2,234 patients and 2,929 lesions.
 
Next, the team used the true-positive, false-positive, false-negative, and true-negative rates from all of the studies to produce a summary of sensitivity, specificity, positive likelihood ratios, negative likelihood ratios, and diagnostic odds ratio. They constructed a receiver operator characteristics (ROC) curve to summarize the true-positive and false-positive rates. They also assessed the quality of the studies using version 2 of the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) method.
 
CEUS showed high sensitivity and specificity:
 
Sensitivity: 88%
Specificity: 80%
Pooled diagnostic odds ratio: 30.35
Area under the curve: 0.9115
Newer agents perform better
 
In further analysis, the researchers also compared the results of studies that used first-generation ultrasound contrast agents such as Levovist (Schering) and second-generation agents such as SonoVue (Bracco Diagnostics). In addition, they assessed the type of contrast mode used in each study.
 
"We found that the second-generation agent group had relatively higher sensitivity and specificity compared with the first-generation group, and the diagnostic performance was
significantly higher in the harmonic mode in comparison with the power/color Doppler mode," Ma said.
 
Performance by contrast media type:
                Sensitivity           Specificity            Diagnostic odds ratio      Area under the curve
1st-generation contrast agents  86%        77%        26.3        0.81
2nd-generation contrast agents                90%        85%        47.2        0.94
Performance by contrast mode
 
                Sensitivity           Specificity            Diagnostic odds ratio      Area under the curve
Power/color Doppler     85%        69%        18.7        0.88
Harmonic             90%        87%        51.6        0.94
 
"Our study suggests that contrast-enhanced sonography is a promising and effective method for differential diagnosis of benign and malignant breast lesions," the authors wrote. "It may be a valuable supplement to fine-needle aspiration [biopsy], which is still needed in cases of Breast Imaging Reporting and Data System category 3 and 4 lesions."
 
Further studies are still required to confirm their findings, according to the group. The researchers also plan to investigate the performance of CEUS in the differential diagnosis of benign and malignant lesions other than breast cancer.
 
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Journal of Ultrasound in Medicine
JUM October 1, 2016 vol. 35 no. 10 2095-2102
Oct 1, 2016
 
Diagnostic Value of Contrast-Enhanced Sonography for Differentiation of Breast Lesions
A Meta-analysis
 
Authors:
Xuelei Ma, MD⇑
State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University, Chengdu, China, Department of Oncology, West China Hospital, Sichuan University, Chengdu, China, Collaborative Innovation Center for Biotherapy, Chengdu, China
Address correspondence to Xuelei Ma, MD, West China Hospital, 37 Guoxue Alley, 610041 Chengdu, China. E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
 
Rongjun Liu, MS
West China School of Medicine, West China Hospital, Sichuan University, Chengdu, China
 
Chenjing Zhu, MD
State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University, Chengdu, China, Collaborative Innovation Center for Biotherapy, Chengdu, China
 
Jing Zhang, MD;  Wenwu Ling, MD
West China School of Medicine, West China Hospital, Sichuan University, Chengdu, China
 
Abstract
 
Objectives— The purpose of this study was to systematically review and evaluate the diagnostic accuracy of contrast-enhanced sonography in the differential diagnosis of benign and malignant breast lesions.
 
Methods— The scientific literature databases PubMed and Embase were comprehensively searched for relevant studies before January 2015. Data were pooled to yield the summary sensitivity, specificity, and diagnostic odds ratio using meta-analysis software.
 
Results— A total of 29 studies with 2296 lesions were included in the analysis. The pooled sensitivity and specificity were 0.88 (95% confidence interval [CI], 0.86–0.90; inconsistency index [I2] = 77.9%) and 0.80 (95% CI, 0.78–0.83; I2 = 84.0%), respectively. The pooled diagnostic odds ratio was 30.35 (95% CI, 15.75–58.48; I2= 82.1%), and the area under the summary receiver operating characteristic curve was 0.9115 (SE, 0.0243).
 
Conclusions— The comprehensive results suggest that contrast-enhanced sonography could be a potentially effective method for differential diagnosis of benign and malignant breast lesions.
 
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Journal of Ultrasound in Medicine
Oct 1, 2016
 
Hepatic Vein Arrival Time for Diagnosis of Liver Cirrhosis
A 10-Year Single-Center Experience With Contrast-Enhanced Sonography
 
Authors: Teresa Abbattista, MD⇑
Division of Radiology, Principe di Piemonte Hospital, Senigallia, Italy
Address correspondence to Teresa Abbattista, MD, Division of Radiology, Principe di Piemonte Hospital, via Cellini 1, 60019 Senigallia, Italy. E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
 
Francesco Ridolfi, MD, PhD
Division of Gastroenterology, Principe di Piemonte Hospital, Senigallia, Italy
 
Giovanni Traina Consalvo, MD
Division of Radiology, Principe di Piemonte Hospital, Senigallia, Italy
 
Eugenio Brunelli, MD
Division of Gastroenterology, Principe di Piemonte Hospital, Senigallia, Italy
 
Abstract
 
Objectives— To evaluate the performance of contrast-enhanced sonography with a second-generation contrast agent in assessing the severity of chronic diffuse liver disease and differentiating cirrhotic from noncirrhotic liver disease.
 
Methods— Contrast-enhanced sonography was performed after intravenous bolus injection of a second-generation contrast agent in 14 healthy control participants and 160 consecutive patients with cirrhotic and noncirrhotic liver disease (n = 78 and 82, respectively) enrolled between March 2004 and April 2014. The intensity of enhancement in a main hepatic vein was used to determine hepatic vein arrival time, time to peak intensity, and peak contrast enhancement.
 
Results— The hepatic vein arrival time was lower in cirrhotic patients compared with both noncirrhotic patients and controls (mean ± SD, 15.0 ± 2.8, 21.5 ± 3.4, and 25.6 ± 4.7 seconds, respectively; P < .05). The hepatic vein arrival time in noncirrhotic patients was also significantly lower than that in controls (P < .05). The time to peak intensity was significantly lower in cirrhotic patients compared with noncirrhotic patients and controls (40.7 ± 13.7, 49.4 ± 12.8, and 51.2 ± 13.7 seconds; P < .05). A receiver operating characteristic curve analysis revealed that the hepatic vein arrival time more accurately excluded a diagnosis of liver cirrhosis than the time to peak intensity (area under the receiver operating characteristic curve, 0.953 versus 0.694). Specifically, a hepatic vein arrival time cutoff value of 17 seconds excluded liver cirrhosis with 91.1% sensitivity and 93.6% specificity.
 
Conclusions— Contrast-enhanced sonography is a valid alternative method for noninvasive staging of liver diseases. The hepatic vein arrival time could be used to exclude liver cirrhosis in a clinical setting.
 
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ICUS
Oct 1, 2016
 
CMS Announces Coding for liver and/or abdominal ultrasound with contrast
 
CMS has announced approval for coverage and coding for liver and/or abdominal ultrasound with contrast under the HOPPS.   Effective October 1, 2016, liver and/or abdominal ultrasound procedures with contrast can be assigned Healthcare Common Procedure Coding System (HCPCS) code C9744, when performed in the hospital outpatient setting.
 
ICUS is pleased with this development, noting the broad use of contrast enhanced ultrasound imaging that has been available for several years in Europe, Asia and elsewhere. It marks a significant step in bringing the US into line with the rest of the world, giving patients access to non-invasive, non-radiation-based diagnostic imaging for tumors and organ systems throughout the body.

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