Regulatory Approval Program for Sleep Study Sensors with Embedded Wireless Links

Advanced Medical Electronics Corporation, Maple Grove MN

Investigators

Abstract

[unreadable] DESCRIPTION (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. [unreadable] [unreadable] [unreadable]