FDA demands a clinical trial and more information for the company's ultrasound-based body contouring device.
Shares in UltraShape Medical Ltd. (TASE: USLP) fell 30% by midday today to NIS 0.059, after the US Food and Drug Administration (FDA) notified the medical device company that it must conduct a clinical trial and provide additional information, if it wanted 501 (k) Premarket Notification (fast track) for the product. UltraShape has developed an ultrasound-based body contouring device.
UltraShape had applied for the FDA Premarket Notification program in June. The program involves less strict procedures, which expedites marketing approval of a product at lower cost.
Published by Globes [online], Israel business news - www.globes-online.com - on October 31, 2010
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