Regulatory Approval Program for Sleep Study Sensors with Embedded Wireless Links

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44MH062251-04
Agency Tracking Number: MH062251
Amount: $511,733.00
Phase: Phase II
Program: SBIR
Awards Year: 2007
Solicitation Year: 2007
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
6901 EAST FISH LAKE ROAD, SUITE #190, MAPLE GROVE, MN, 55369
DUNS: 927303412
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: Y
Principal Investigator
 KEVIN KRAMER
 (763) 463-4814
 kkramer@ame-corp.com
Business Contact
 TOM HENDRICKSON
Phone: (763) 463-4814
Email: THENDRICKSON@AME-CORP.COM
Research Institution
N/A
Abstract
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.

* Information listed above is at the time of submission. *

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