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February 20, 2014
07:23 EDTNSPRFDA Anesthesiology & Respiratory Therapy Devices Panel Meeting
The panel discusses, makes recommendations and votes on information related to Inspire Medical Systems' Premarket Approval Application (PMA) regarding the Company's Inspire II Upper Airway Stimulator in a meeting being held at FDA Silver Spring, Maryland offices on February 20 at 8 am. Webcast Link
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October 29, 2014
09:13 EDTNSPRInspireMD's IDE amendment approved by the FDA
InspireMD announced that the FDA has approved the company's submitted IDE amendment for certain manufacturing process changes to the MGuard Prime EPS that were proposed in response to the Company's April 30, 2014 Voluntary Field Action. InspireMD said while patient enrollment in the US MASTER II trial has been discontinued, which was intended to support this IDE application, the FDA's approval of the IDE amendment is an important endorsement of the process changes. The company received European regulatory approval for these process changes in June, and now believes all returned MGuard Prime EPS inventory has been successfully modified and returned to direct hospital customers and the majority of their distributors. As such, the Company resumed full commercial activities in direct markets in Western Europe as of mid-October and expects direct and distributor based selling to ramp up throughout the fourth quarter of 2014.

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