Company

About DynaWell^®

DynaWell^® is a privately owned US based medical technology company founded in 1998. We have our headquarters in Las Vegas, USA. For further information go to "contacts".
 

DynaWell® develops, produces, markets and sells enhanced imaging products for use by health care practitioners. DynaWell's line of products is designed to improve the diagnostic capabilities of computer tomography ("CT") and Magnetic Resonance Imaging ("MRI"). DynaWell's first product is the DynaWell® L-Spine, a diagnostic appliance designed to improve the accuracy of MRI/CT examinations of the lower spine.

Anders Mjärdsjö, President and CEO

Our mission is to assist medical professionals by offering sophisticated diagnostic techniques for CT and MRI scanners. This provides a more accurate diagnosis to enhance the possibility of optimal and cost-effective treatment. Ultimately, we strive to help people who are experiencing pain or discomfort to return to a pain free life. In line of our business concept, we concentrate on developing enhanced imaging products for computer tomography (CT) and magnetic resonance imaging (MRI).
 
DynaWell's first product ready to market, DynaWell^® L-Spine, is a diagnostic appliance designed to improve the accuracy of MRI/CT examinations of the lower spine. Since most patients experience lumbar pain while standing, traditional MRI/CT examinations performed while lying down can leave some conditions undetected. The standard examination is performed with the patient lying inside a CT or MRI scanner. The results of a CT or MRI examination performed while the patient is lying down can leave some conditions undetected. This is because the optimal way for a patient with back pain to be diagnosed is in a standing position with the normal gravitational pressure exerted on the spine. This is impractical, however, since it would require the patient to stand motionless for about half an hour. In addition, existing CT and MRI scanners have been designed to scan patients in the supine position. The Company's product, DynaWell^® L-Spine, when worn by the patient, allows the patient to remain in the supine position with straightened hips and knees while at the same time simulating the pressure on the spine as if the patient were in a standing position
 
On August 13, 1999, the Food and Drug Administration ("FDA"), pursuant to the Company's 510(k) pre-market notification, approved the product for marketing. The product is classified in Regulatory Class: II 510(k) No. K992120 with an indication for use as an accessory for axial compression of the lumbar spine in CT and MRI diagnostic imaging for enhanced and more relevant diagnosis during research and clinical purposes. On March 14, 2000, the product obtained in Europe, the CE-mark approval (Registration No. 41313339) as a device for improved radiological diagnosis through compression of the spine with measuring functions.