Regulatory Approval Program for Sleep Study Sensors with Embedded Wireless Links

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$511,733.00
Award Year:
2007
Program:
SBIR
Phase:
Phase II
Contract:
2R44MH062251-04
Award Id:
61111
Agency Tracking Number:
MH062251
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
6901 EAST FISH LAKE ROAD, SUITE #190, MAPLE GROVE, MN, 55369
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
927303412
Principal Investigator:
KEVINKRAMER
(763) 463-4814
KKRAMER@AME-CORP.COM
Business Contact:
TOMHENDRICKSON
(763) 463-4814
THENDRICKSON@AME-CORP.COM
Research Institute:
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 200 5 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 packag e 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 commerc ial sale of the device.

* information listed above is at the time of submission.

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