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Need immediate help or have basic questions about AMRA’s services or technology? Start by exploring our Frequently Asked Questions below, where you’ll find quick answers to the most common questions asked by our network, across both our research services and our medical device offerings.

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Frequently Asked Questions

Clinical Services: What is the intended use of the AMRA® Profiler service?

AMRA® Profiler 4 is indicated for use as a Magnetic Resonance (MR) diagnostic device software application for non- invasive fat and muscle evaluation that enables the generation, display and review of 2D MR medical image data. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.

Clinical Services: How long does it take to get the AMRA® BCP Scan results?

Our standard deliveries are normally provided within 2 business days. In certain cases, more rapid deliveries are available within a 24-hour timeframe. Please contact your Business Development representative for further information: BD@amramedical.com.

Clinical Services: How long is the acquisition time for the AMRA® BCP Scan?

This is dependent upon the MR system being used and the experience of the technicians, however, our standard Profiler 4 BCP (body composition profile) protocol takes approximately 8 minutes.

Clinical Services: How much does it cost?

Cost is dependent upon the number of sites, scans, measurements, and delivery outputs. Costs do not include separate charges from the facility where the scanning is being performed. Please contact our Business Development representatives to discuss our program in detail at: BD@amramedical.com.

Clinical Services: Do you offer free trials?

There is no trial version available due to regulatory restrictions for data transfer, but if you are interested in our services, please contact our Business Development team at BD@amramedical.com.

Clinical Services: Where in the world is the product approved and regulated for clinical usage?

AMRA® Profiler 4 is 510k-cleared for use in the USA (K211983), CE-marked in the EU (NB 2862), and available for clinical use in Sweden, Germany and the United Kingdom. AMRA® Profiler 4 is also registered as a Class I product under MDEL for use in Canada.

Clinical Services: How is the private health information of my patients protected?

All personal health information is removed during the upload of images to AMRA. AMRA® Profiler 4 is HIPAA compliant and is CE-marked under MDR by NB 2862

Clinical Services: How can I place an order?

To get a quote or place an order, use our Get a Quote page or contact our Business Development team at BD@amramedical.com

Clinical Services: What measurements does AMRA® Profiler 4 have available to me?

Visceral Fat, Subcutaneous Fat (abdominal), Muscle Volume (thigh), Muscle Fat (thigh), and Liver Fat (PDFF).

Clinical Services: What do I get as final output from the service?

Standard results are individual PDF reports delivered to your PACS system within 2 business days.

Research Services: How long is the scan time for AMRA’s image acquisition?

This is dependent upon the MRI system being used, the experience of the technicians, and the measurement aims from our analysis. Our standard BCP (body composition profile) protocol takes approximately 8 minutes, while our neuromuscular protocols take closer to 30-45 minutes.

Research Services: What measurements does AMRA have available to me?

Our AMRA® Researcher offers flexibility in your biomarker and analytic needs. Please see Our Services (link here) for an in-depth understanding of the services AMRA can provide.

Research Services: Is the (MRI) image acquisition protocol the same for every study?

We have developed standard protocols that work for most scanners. The appropriate protocol will be determined during the site and scanner certification process. There may be instances when AMRA’s protocol may need to be used in combination with other sequences or must be tweaked based on the study or the patient population included, which will require additional support from our technical team. Please contact info@amramedical.com for further information pertaining to your study needs.

Research Services: What do I get as final output from the service?

Depending on the products and your needs, output is most commonly presented as a spreadsheet. For additional options for receiving data output based on your requirements, please reach out to BD@amramedical.com.

Who do I call if I want to apply for a job?

Please contact jobs@amramedical.com.

Who do I call if I have questions about a specific study or project?

For information related to a new project, please contact our Business Development team at BD@amramedical.com. For questions related to an ongoing study, please contact support@amramedical.com.

Who do I call for invoicing problems?

Please contact finance@amramedical.com

Who do I call if I have technical questions?

You can create a support case on our support page and our technical support will get in contact with you. Please contact support@amramedical.com.

Do I need to install anything?

No software needs to be installed at the scanning facility since the image analysis is cloud-based. It is required that the correct scanning protocol instructions are installed on the MRI machine.

Is AMRA’s technology validated?

The accuracy and precision of AMRA’s technology has been validated in terms of internal and external independent validation studies [1-8] as part of our research services, and our 510k-cleared and CE-marked medical device, AMRA Profiler 4 (NB 2862). Accuracy and precision has been fully determined by test-retest image acquisitions and blinded analysis.

Will AMRA® MRI protocols work on my MRI scanner?

Please explore our Get Started page (https://amramedical.com/get-started), where you can download our Service Requirements document. We support most modern 1.5T and 3T GE, Siemens, and Philips MR scanners, and this document will specify the software versions needed. After you have confirmed that we can support you, please contact us at BD@amramedical.com.

How are my images transferred from the scanner to AMRA?

Captured images are uploaded to InteleShare for subsequent transfer to AMRA. This is a secure, web uploader-based transfer service that performs de-identification of PHI or anonymization for research prior to transmission to our servers.

What services does AMRA offer?

AMRA is the first company in the world to offer an automated, cloud-based service where MR images are analyzed for precise, standardized, 3D volumetric fat and muscle composition. MR images are acquired using a rapid whole-body or neck-to-knee protocol, available to imaging sites on most GE, Siemens, and Philips machines. De-identified images are then transferred to AMRA for quality control and analysis. Our Research Biomarker Service, powered by AMRA® Researcher, provides our clients with a wide array of measures for clinical research. In the clinic, our medical device (NB 2862), AMRA® Profiler 4, provides easy-to-understand & individualized insights for each patient profile.

Who are AMRA’s clients and partners?

AMRA’s primary clientele includes life sciences organizations where we partner with pharmaceutical companies & clinical research teams, CR/iCRO and biotechs, academic research institutions, and health & wellness centers.

References

  1. Thomas MS, Newman D, Leinhard OD, Kasmai B, Greenwood R, Malcolm PN, Karlsson A, Rosander J, Borga M, Toms AP. Test-retest reliability of automated whole body and compartmental muscle volume measurements on a wide bore 3T MR system. Eur Radiol 2014;24(9):2279-2291.
  2. Borga M, Thomas EL, Romu T, Rosander J, Fitzpatrick J, Dahlqvist Leinhard O, Bell JD. Validation of a fast method for quantification of intra-abdominal and subcutaneous adipose tissue for large-scale human studies. NMR Biomed 2015;28(12):1747-1753.
  3. Karlsson A, Rosander J, Romu T, Tallberg J, Grönqvist A, Borga M, Dahlqvist Leinhard O. Automatic and quantitative assessment of regional muscle volume by multi-atlas segmentation using whole-body water-fat MRI. J Magn Reson Imaging 2015;41(6):1558-1569.
  4. Newman D, Kelly-Morland C, Leinhard OD, Kasmai B, Greenwood R, Malcolm PN, Romu T, Borga M, Toms AP. Test-retest reliability of rapid whole body and compartmental fat volume quantification on a widebore 3T MR system in normal-weight, overweight, and obese subjects. J Magn Reson Imaging 2016;44(6):1464-1473.
  1. Peterson P, Romu T, Brorson H, Dahlqvist Leinhard O, Månsson S. Fat quantification in skeletal muscle using multigradient-echo imaging: Comparison of fat and water references. J Magn Reson Imaging 2016;43(1):203-212.
  2. Middleton MS, Haufe W, Hooker J, Borga M, Dahlqvist Leinhard O, Romu T, Tunon P, Hamilton G, Wolfson T, Gamst A, Loomba R, Sirlin CB. Quantifying abdominal adipose tissue and thigh muscle volume and hepatic proton density fat fraction: Repeatability and accuracy of an MR imaging-based, semiautomated analysis method. Radiology 2017;283(2):438-449.
  3. West J, Romu T, Thorell S, Lindblom H, Berin E, Holm AS, Åstrand LL, Karlsson A, Borga M, Hammar M, Leinhard OD. Precision of MRI-based body composition measurements of postmenopausal women. PLoS One 2018;13(2):e0192495.
  4. Borga M, Ahlgren A, Romu T, Widholm P, Dahlqvist Leinhard O, West J. Reproducibility and repeatability of MRI-based body composition analysis. Magn Reson Med 2020;84(6):31