Regulatory Approval Program for Sleep Study Sensors with Embedded Wireless Links
Department of Health and Human Services
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Small Business Information
ADVANCED MEDICAL ELECTRONICS CORPORATION
6901 EAST FISH LAKE ROAD, SUITE #190, MAPLE GROVE, MN, 55369
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): This competing continuation SBIR application proposes to complete a regulatory approvals program on a set of next-generation sleep disorder monitoring sensors. Advanced Medical Electronics (AME) completed in June of 2005 a phase II NIMH SBIR developing sleep sensors with embedded wireless links. AME completed on this phase II program the development of a set of production prototype wireless sleep sensors and created a polysomnograph recording and analysis software package for use with the developed sensors. This application seeks funding to perform FDA required regulatory approvals testing for the developed wire- less polysomnograph sensors and the associated software package. FDA approval is required prior to the commercial sale of the device.
* information listed above is at the time of submission.