Abstract
| Grant Number: | 2R44MH062251-04 |
| Project Title: | Regulatory Approval Program for Sleep Study Sensors with Embedded Wireless Links |
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.
Thesaurus Terms:
biomedical equipment development, biomedical equipment safety, evaluation /testing, patient monitoring device, polysomnography, sleep
miniature biomedical equipment, portable biomedical equipment, sleep apnea, telemedicine, telemetry
clinical research
| Institution: | ADVANCED MEDICAL ELECTRONICS CORPORATION |
| SUITE #190 |
| MAPLE GROVE, MN 55369 |
| Fiscal Year: | 2007 |
| Department: | |
| Project Start: | 01-AUG-2000 |
| Project End: | 14-APR-2008 |
| ICD: | NATIONAL INSTITUTE OF MENTAL HEALTH |
| IRG: | ZRG1 |
|
