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Sunlight To Pursue Omnisense Bone Sonometer Multi-Site Indications In U.S.

This article was originally published in The Gray Sheet

Executive Summary

Sunlight Ultrasound Technologies plans to pursue FDA approval of multi-site indications for its Omnisense ultrasound bone sonometer following Jan. 20 premarket approval for assessing skeletal fragility along the distal radius (wrist) bone.

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Norland Medical

Agreement with U.K.-based McCue plc gives Norland distribution and service rights for that company's ultrasound-based bone measurement systems, the firm announces June 17. Marketed as the CUBAClinical system in the U.K., the distribution and service agreement gives Norland rights to Canada, the Middle East, the Pacific Rim, parts of Europe and the U.S. following FDA approval, which is expected by year-end. In addition to being cost-effective and widely used in the U.K., the system utilizes "one of the largest clinical databases of any ultrasound bone measurement system on the market," Norland claims

Lunar Launching Achilles+ Bone Sonometer Week Of July 6

Lunar plans to begin shipments of its Achilles+ bone sonometer the week of July 6 for diagnosing osteoporosis and estimating a patient's risk for bone fracture. FDA approved the company's premarket approval application on June 26.

Myriad Seeking Distributor For SoundScan Bone Sonometer Approved By FDA

Myriad Ultrasound currently is negotiating with a number of potential U.S. distributors for its SoundScan family of bone sonometers following FDA approval, announced June 3.

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