a new era in ambulatory monitoring
of Ventura, California is on the threshold of making remote-monitoring
of patients enrolled in clinical drug trials a reality. The
southern California company's flagship product, LifeShirt,
an ambulatory monitoring vest, has the potential of improving
the accuracy and the speed with which data are collected,
while lowering the cost of trials by reducing the need for
frequent clinical visits to record patients' vital signs.
The data collection component of VivoMetrics LifeShirt System is
a sleeveless undergarment that functions as a multichannel cardiopulmonary
digital recorder. The shirt is made of hand-washable, reusable stretch-material
into which are sewn an array of physiologic sensors to monitor 30+
vital signs. The individual being monitored can self-report symptoms,
activities and medications into the PDA which then become part of
the digital data stream. Any peripheral diagnostic device with digital
output may be plugged into the serial port and its (their) measurements
also become part of the digital data stream, e.g. pulse oximeter
blood pressure, temperature, weight, etc. The data is stored on
a module containing a data card that is incorporated into a customized
Handspring worn on the patients belt or carried in a pocket.
How it works
Periodically the patient will upload the data, via
the Internet to the VivoMetrics' secure data center. The data center
is staffed by technicians and physicians who review the quality
of information and prepare it for subsequent distribution to clinical
investigators or the pharmaceutical company conducting the research.
Ultimately, the company hopes to take its monitoring system a step
further, and introduce a wireless version that will transmit the
data captured directly from the patient wearing the LifeShirt to
VivoMetrics data center.
RespiEvents, the software that powers the monitoring system was
developed by Non-Invasive Monitoring Systems, Inc. (NIMS). NIMS
received FDA 510K clearance for expanded indication of its RespiEvents
monitoring software in August 2000. This expanded indication allows
for data currently monitored in hospitals to be gathered in an ambulatory
LifeShirt is currently not approved by the FDA, however company
executives point out that the technology imbedded in LifeShirt has
been in constant use in the clinical environment for many years,
and hope to receive FDA clearance in the near future.
Editor PDA cortex