MindwaysCT receives 510(k) clearance for “no-dose” bone densitometry technology.

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MindwaysCT has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its asynchronous QCT calibration technology for CT-based bone mineral density measurement.

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MindwaysCT’s latest Quantitative Computed Tomography (QCT) software innovation makes it possible to assess bone mineral density (BMD) using QCT without the need to scan a calibration phantom together with the patient. Not only does this mean easier QCT workflow; but, more importantly, now any non IV-contrast abdominal or pelvic CT scan ordered for another purpose can be used for additional bone density measurement with no further patient radiation exposure or time.

Mindways VP of Business Development, Alan Brett PhD said: we are very excited about getting this innovative technology into healthcare practice. Because there is a great deal of overlap between patients getting a CT scan and those at risk of bone loss and consequent fragility fractures, the dual-use of CT scans provides for a very efficient method of screening for low bone mass and early identification patients that would benefit from treatment. This is very important because of the catastrophic nature of osteoporotic hip fractures.

The new technology works by using a previously acquired calibration scan to convert a CT image into bone mineral density values. In addition to regular CT scans, a successful pilot study has focussed on the feasibility of a combined CT Colonography (CTC) and osteoporosis assessment screening program. Because patients undergoing CTC screening are usually over the age of 50, they will be at risk of low bone mass, which is a particular concern for postmenopausal women. The dual use of a CTC scan can offer these patients “no-dose” BMD testing without the need to schedule a DXA test.

The new technology can also offer retrospective analysis of previously acquired images, by interrogating a PACS store for CT scans of appropriate patient groups. The new technology will be available in the last quarter of 2014.

For more information on MindwaysCT and QCT Pro™, please visit http://www.qct.com.

About MindwaysCT
Mindways Software, Inc. produces Quantitative CT (QCT) bone densitometry products for spine and hip bone density measurements. Mindways premier product, QCT Pro™ uses QCT images to derive DXA-like hip BMD measurements and volumetric spine BMD measurements. QCT Pro™ hip BMD measurements are interpreted in the same manner as DXA and are included in the WHO FRAX® online fracture risk calculator, while spine measurements provide exceptional sensitivity to short-term bone density change. QCT Pro™ is fast, easy to use, reimbursable, and provides the same clinical utility as DXA at a fraction of its cost.

For more information visit: http://www.qct.com.

Media Contact:
Alan Brett, VP Business Development
+1 512 912 0871

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