Therapeutic Monitoring Systems Announces FDA 510(k) Clearance of Vital Sign Variability Software

CIMVA Universal - a software platform supporting a range of clinical decision support and diagnostic applications
By: Therapeutic Monitoring Systems (TMS) Inc.
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Medical Device
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Variability Analysis
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Ottawa - Ontario - Canada

OTTAWA, Ontario - March 28, 2013 - PRLog -- OTTAWA, Ontario - Therapeutic Monitoring Systems (TMS), an innovative provider of clinical decision support and diagnostic applications based on multi-organ vital sign variability analysis, today announced  that the  U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the Company to market  CIMVA Universal Version 1.0, a software platform for analyzing patterns of variation in multiple physiological parameters (heart rate and respiratory rate) derived from third party vital sign monitoring systems.  

"We are exceptionally pleased to have received FDA clearance for CIMVA Universal 1.0, the first regulatory cleared multi-organ and multi-parameter variability software product", said Dr. Andrew Seely, Founder and Chief Science Officer at TMS.  "We are convinced that vital sign variability analysis will significantly improve clinical decision making across a range of scenarios, thereby improving healthcare outcomes, and reducing costs.   In particular, we are conducting multi-center clinical studies in the U.S. and Canada to demonstrate the value of variability analysis in determining the right time to wean patients off of mechanical ventilation in the ICU setting and to assist in triage decision making for patients presenting with sepsis in the Emergency Department."  

Vital sign variability analysis has been the subject of countless research papers and studies, dating back as far as the 1980s, involving studies in heart disease, critical illness, infection and more; and recently, monitoring heart rate variability has proven to save lives through early detection of sepsis in neonatal patients.   The correlation between variations in physiological parameters and changing patient health is widely documented and accepted.  TMS is the first in the world to apply these techniques to multiple physiologic parameters simultaneously and continuously for the benefit of individual patient decision making, based upon patents for the application of multi-parameter variability analysis to assist clinical decision-making in critical care, general ward and outpatient settings.  

“This important milestone reflects TMS’ commitment to innovation.   It is our first 510(k) clearance and provides the Company with an excellent foundation upon which to bring to market a series of specific clinical software applications and diagnostics aimed at improved clinical decision making.   We are dedicated to helping our customers improve patient outcomes and reduce costs through better informed clinical decisions," said David Longbottom, Chief Executive Officer.

About Therapeutic Monitoring Systems
TMS is commercializing software applications for critical care medicine to materially improve patient care decisions and reduce the cost of care.   TMS has licensed technology from the Ottawa Hospital Research Institute.   Venture investors include Genesys Capital, the MaRS Investment Accelerator Fund & the Queen’s TriColour Venture Fund.  TMS has also received financial & advisory support from Ontario’s Health Technology Exchange, FedDev Ontario, the Ontario Centres of Excellence, the Federal Industrial Research Assistance Program, the MaRS Discovery District in Toronto & the Ottawa Technology Transfer Network.

Simon Goulet, Chief Operating Officer
(613) 368-4311 x 403
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Phone:1-613-368-4311 x 403
Tags:Medical Device, Fda Approval, Variability Analysis, Clinical Decision Support, Medical Software
Industry:Medical, Software
Location:Ottawa - Ontario - Canada
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