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Automated point-of-care identification of innocent Still's murmur in children

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42HL131081-02
Agency Tracking Number: R42HL131081
Amount: $1,473,580.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA18-576
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-04-01
Award End Date (Contract End Date): 2021-03-31
Small Business Information
Dayton, MD 21036-1142
United States
DUNS: 079727453
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (202) 476-5000
Business Contact
Phone: (202) 476-1201
Research Institution
WASHINGTON, DC 20010-2916
United States

 Domestic Nonprofit Research Organization

The overall goal of the proposed research and technology transfer effort is to develop a low-cost,
point-of-care, mobile device-based technology for automated identification of Stillandapos;s murmur,
the most common innocent (benign and harmless) heart murmur of childhood. This novel
technology could reduce the current rate of over half a million children unnecessarily referred to
pediatric cardiologists by primary care providers each year in the United States. In Phase I,
AusculTech Dx and Childrenandapos;s National Medical Center developed a machine-learning algorithm
capable of identifying Stillandapos;s murmur with high accuracy (90% sensitivity, 99% specificity). To
enable digital recording, essential for computerized murmur analysis, we also developed a
digital stethoscope that connects to a smartphone and is equivalent in performance to a
commercial stethoscope. Our envisioned product, called StethAid, is a combination of this novel
digital stethoscope and a smartphone application (app). Having successfully met the Phase I
performance milestones, we now propose to fully develop StethAid and conduct a multicenter
trial through the following three specific aims: (1) develop and test a clinical-grade digital
stethoscope, (2) develop fully feature software app, (3) conduct a multicenter trial of automated
Stillandapos;s murmur identification. For the multicenter trial, we have expanded our collaboration to
include Boston Childrenandapos;s Hospital and Walter Reed National Military Medical Center. Our
deliverable for Phase II is a technology platform validated by leading pediatric cardiologists that
is ready for seeking regulatory approvals, deployment at PCP offices, and commercialization. As
a decision support system, StethAid could empower PCPs to identify Stillandapos;s murmur accurately
and thus reduce the huge number of unnecessary specialist referrals. This should save the
healthcare system hundreds of millions of dollars annually, allow pediatric cardiologists to focus
on patients with serious conditions, and protect healthy children and their families from the
unnecessary anxiety, inconvenience, and expense of seeing a pediatric cardiologist.PROJECT NARRATIVE
Over half a million children are referred unnecessarily to pediatric cardiologists by general
physicians for the evaluation of Stillandapos;s murmur, a normal and harmless heart murmur. This
project will develop and clinically validate a novel mobile technology for automated recognition
of this murmur in order to reduce the current rate of such unnecessary referrals and associated
costs and inconvenience.

* Information listed above is at the time of submission. *

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