The medical device firm was asked for more details before it proceeds to Phase III trials.
Medical equipment company Medigus Ltd. (TASE:MDGS) said yesterday that the US Food and Drug Administration (FDA) has turned down its application to begin a multi-center trial of its SRS endoscopy system for the treatment of Gastro Esophageal Reflux Disease (GERD). The company had submitted a 510K application to secure FDA approval to commence marketing of its product.
At the beginning of August, Medigus announced that it would commence Phase III clinical trials ahead of the approval of its device in the US, and filed an application to begin a multi-center trial prior to obtaining marketing approval for its device.
"The FDA has advised the company that its application has not been approved in its present format, and the company has been asked by the FDA to provide further information on its endoscope and SRS system," said Medigus in its notification to the TASE. The company added that it expected to complete the revision of its presentation within 10-12 weeks and that this would delay approval for its device by two to three months.
Published by Globes [online], Israel business news - www.globes.co.il - on September 4, 2007
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