LifeShirt System Receives FDA Clearance
|VENTURA, Calif. VivoMetrics
Inc. has received U.S. Food and Drug Administration (FDA)
clearance to market its LifeShirt System, a suite of products
and services for the continuous collection, analysis and reporting
of ambulatory physiologic data. This clears the way for immediate
commercialization of the LifeShirt System, which is designed
to provide pharmaceutical/medical researchers and clinicians
with comprehensive, real-world physiologic data for making better
research decisions and improving patient care around the globe.
The LifeShirt System is the first non-invasive, continuous
ambulatory monitoring system that can collect data on cardiopulmonary
function and other physiological and subjective patient parameters,
and correlate them over time. Using data from the LifeShirt
System, researchers and clinicians gain a clear view of how
various physiologic systems interact, giving them a more thorough
understanding of patients' health.
"With the LifeShirt System, researchers and clinicians have
an unprecedented window into everyday human physiology," said
Paul Kennedy, president and chief executive officer of VivoMetrics.
"Having this data at their fingertips will allow them to see
signatures and predictors
of disease that no one has been able to identify before, ultimately
improving the care of patients and the development of new medicines."
VivoMetrics' initial commercial focus will center
on three markets: clinical trials for new drugs and medical devices;
home sleep diagnostics; and academic research into causes and prevention
of respiratory, cardiovascular, behavioral health and sleep-related
"The LifeShirt System is a powerful tool for evaluating a
drug's effects in the natural environment of patients," said
Frank Wilhelm, a senior research scholar at the Department of Psychiatry
and Behavioral Sciences, Stanford University School of Medicine.
"The system's monitoring technology and signal analysis software
are so advanced that it can automatically detect and classify apneas
or hypopneas, Cheyne-Stokes respiration, sighs, and coughs, and
correlate these with cardiac or other parameters all outside
of the laboratory or clinical setting. The LifeShirt System should
be of great use in understanding how different bodily systems interact
in health and disease."
LifeShirt System Technology
The LifeShirt System's central component is a lightweight,
comfortable, washable garment that has sensors embedded in its fabric.
The system features an enhanced, ambulatory version of the technology
that is currently the gold standard for in-hospital, non-invasive
respiratory monitoring and apnea detection. Other sensors monitor
heart function, posture and physical activity, and an electronic
patient diary function captures subjective patient experiences,
such as moods, symptoms and the activities of daily living. The
LifeShirt System correlates the various physiologic and subjective
data over time, supplying a comprehensive "movie" of patients'
In addition to bringing standard-setting monitoring technology
out of the hospital to outpatient settings, the LifeShirt System
will help researchers and clinicians comply with new government
mandates for submission of clinical trial and research data. Information
collected by the LifeShirt garment is encrypted and recorded in
the LifeShirt Recorder, a small, easy-to-use handheld computer.
Data are then processed and analyzed using VivoLogic software
and presented to researchers and clinicians as full-disclosure,
high-resolution waveforms or as easy-to-interpret summary reports.
All data produced by the system meet standards set forth in the
FDA's rule 21 CFR Part 11, which governs the digital collection,
presentation and archiving of physiologic data.
FDA clearance for the LifeShirt System is the latest
in a series of regulatory successes for VivoMetrics. In November
2001 the LifeShirt System received CE Mark certification, clearing
the way for commercialization of the system in the European Economic
Area. Also in November, VivoMetrics announced receipt of ISO 9001
registration, a globally recognized quality-assurance standard governed
by the International Organization of Standardization.
Founded in 1999, VivoMetrics is a privately held company
that provides continuous ambulatory monitoring products and services
for the collection, analysis and reporting of patient-specific physiologic
data. The company's offerings, based on proprietary, field-tested
technologies, have the potential to change the way clinical research
is conducted and medicine is practiced.