PositiveID Corporation announced that it has engaged Magellan Medical Technology Consultants ("Magellan") to lead the U.S. FDA submission process for the Company's iGlucose 510(k). PositiveID and Magellan expect to submit the iGlucose 510(k), including required clinical research study and validation data, to the FDA in the third quarter of 2010.
Magellan is a full-service consulting organization focused exclusively on the medical technology industry. Magellan has a broad range of expertise including clinical research, regulatory affairs, reimbursement strategy, and marketing and sales. Magellan will assist PositiveID with the development and presentation of the iGlucose 510(k) submission documents, as well as provide support for clinical data and validation studies.
Device manufacturers are required to notify the FDA of their intent to market a medical device at least 90 days in advance; this is known as Premarket Notification also called PMN or 510(k). As part of its 510(k) submission, the Company will supply patient clinical and software validation data.
The Company believes its iGlucose system provides next generation, real-time data to improve diabetes management and help ensure patient compliance, data accuracy and insurance reimbursement. The iGlucose system functions without the use of a cell phone, wireless network, telephone line or personal computer. At the patient's discretion, blood glucose data can also be forwarded to physicians and caregivers at predetermined intervals.
Scott R. Silverman, Chairman and CEO of PositiveID, said, "Magellan is a leading medical consulting organization that has a proven track record of getting new products to market quickly and effectively. We believe their superior product development and regulatory management expertise well-position us to successfully commercialize the iGlucose system."
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