Andante Medical Devices Ltd Receives CE Mark for Its Gait Rehabilitation Device SmartStep(TM) and ISO 13485 Approval for Its Omer, Israel Facility.OMER, Israel -- Andante an·dan·te Music adv. & adj. Abbr. and. In a moderately slow tempo, usually considered to be slower than allegretto but faster than adagio. Used chiefly as a direction. n. An andante passage or movement. Medical Devices Ltd is pleased to announce receipt of a CE Mark approval for its premier product SmartStep(TM). Andante has also been approved for compliance with standard ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 13485 for the manufacture of its products. Andante, a privately owned medical device company, launched SmartStep(TM) in the Israeli market in April 2005 and intends to enter the European and US markets via a distributor and dealer network in the coming months. Andante will market to physical therapy clinics and rehabilitation centers. SmartStep(TM) is an innovative portable biofeedback device biofeedback device Any instrument that measures physiologic parameters eg electromyographic activity, galvanic–electrodermal skin resistance, muscle tension, BP, and others; some mainstream physicians believe BDs may be used to control tachycardia, HTN, fecal developed to improve gait during rehabilitation. It is suitable for patients recovering from neurological, orthopedic, and other disorders affecting the lower limb. This includes patients with stroke, lower extremity lower extremity n. The hip, thigh, leg, ankle, or foot. Also called inferior limb, pelvic limb. fractures, joint replacement, and soft tissue injuries (especially ligament tears) particularly as a result of sports. SmartStep(TM) has been cleared by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for commercial sales. This press release contains forward-looking statements that are subject to risks and uncertainties. Factors that could cause actual results to differ materially from these forward-looking statements include, but are not limited to, general business conditions in the industry, market acceptance of new products, changes in demand for products, the timing and amount or cancellation of orders and other risks. |
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