Neonatal Intensive Care Unit Telemetry System

Period of Performance: 09/01/2006 - 08/31/2008

$361K

Phase 2 SBIR

Recipient Firm

Cleveland Medical Devices, Inc.
CLEVELAND, OH 44103
Principal Investigator

Abstract

DESCRIPTION (provided by applicant): The objective is to develop a miniature, wireless, multi-channel, neonatal intensive care unit (NICU) & monitoring system that provides physiological and behavioral parameters. The system utilizes a small physiological monitor and isolette mounted camera. The NICU is an extremely challenging environment since patients are small, medically fragile, and surrounded by bulky equipment. Current bedside devices are large and cumbersome, which impede nursing care and inhibit clinical traffic. Continuous physiologic monitoring can provide critical data to guide diagnosis and treatment. An unobtrusive monitoring system that can be placed directly into the isolette would allow continuous monitoring while minimizing patient hazards and inconvenience. The final commercial system will provide a small, lightweight wireless system for unobtrusive NICU monitoring. Specifically during the continuing Phase II effort, we plan to upgrade the radio link, increase external sensors options, minimize cost, and ensure the system meets medical equipment quality standards. Software upgrades will improve user friendliness, integrate new tools to compare studies, and provide customizable reporting features. New algorithms will be integrated to improve utility and research flexibility. Significant verification and validation testing will ensure that all applicable standards are met. Finally a large clinical trial will be completed with neonatal subjects to ensure clinical efficacy.