Periodic Reporting for period 1 - eMurmur (eMurmur, a software based, clinically tested medical device for automated heart murmur detection)
Okres sprawozdawczy: 2015-07-01 do 2015-10-31
The auscultation of the heart using a stethoscope is the standard examination method worldwide to screen for heart defects, thus identifying murmurs. It requires that examining physicians have acute hearing and extensive experience, as there is no currently available technology that can perform this test. Achieving an accurate diagnosis remains challenging for various reasons including noise, high heart rates, and distinguishing innocent from pathological murmurs. Since objective screening tools are unavailable, the risk of human error is increased and the current reliance on subjective screening creates concerns surrounding consistency, accuracy and objectivity. This is evidenced by the fact that up to 70% of asymptomatic children who are referred to specialist evaluation or echocardiography because of a suspected murmur are not suffering from heart disease. The result of the reliance on subjective screening methods is a high number of patients who end up undergoing unnecessary heart testing. In addition to patient anxiety and inconvenience, the unnecessary costs in the US alone amount to over one billion USD annually.
CSD Labs' medical device eMurmur is a clinically tested screening tool for the objective detection of heart murmurs. eMurmur analyses and classifies heart sounds acquired via electronic stethoscope or other appropriate recording hardware. The eMurmur system is comprised of an app that runs on a mobile device; server-based heart sound analysis medical software; and a corresponding auscultation database. eMurmur can be utilized by medical professionals performing auscultations in their daily routine right at the patient’s side. Moreover, eMurmur offers medical professionals the capacity to electronically document auscultation findings, integrate them into electronic patient records, or share data with other health care professionals for expert opinions.
CSD Labs' medical device eMurmur is a clinically tested screening tool for the objective detection of heart murmurs. eMurmur analyses and classifies heart sounds acquired via electronic stethoscope or other appropriate recording hardware. The eMurmur system is comprised of an app that runs on a mobile device; server-based heart sound analysis medical software; and a corresponding auscultation database. eMurmur can be utilized by medical professionals performing auscultations in their daily routine right at the patient’s side. Moreover, eMurmur offers medical professionals the capacity to electronically document auscultation findings, integrate them into electronic patient records, or share data with other health care professionals for expert opinions.
CSD Labs’ work during the course of the phase 1 project has enabled them to:
• clearly identify the technical milestones required to further improve the eMurmur system
• obtain positive FDA feedback on the clinical validation of the eMurmur system for FDA approval
• lay out a clearly structured QM-plan usable for both CE and FDA approvals
• confirm the vast market potential for the eMurmur system in both the EU and US
• map a clear path-to-market strategy based on the identification of initial key market opportunities and devise a corresponding marketing strategy
• form a deeper understanding of the competition along with their strengths and weaknesses and the potential for shared opportunities
• clearly identify the technical milestones required to further improve the eMurmur system
• obtain positive FDA feedback on the clinical validation of the eMurmur system for FDA approval
• lay out a clearly structured QM-plan usable for both CE and FDA approvals
• confirm the vast market potential for the eMurmur system in both the EU and US
• map a clear path-to-market strategy based on the identification of initial key market opportunities and devise a corresponding marketing strategy
• form a deeper understanding of the competition along with their strengths and weaknesses and the potential for shared opportunities
The outcome of the work conducted during this project confirms the validity of the eMurmur technology and its potential to become a disruptive force in auscultation. The societal implications of eMurmur being used by primary care physicians and hospitals are significant: for the first time, the 200 year–old, largely unchanged method of a physician listening to a patient's heart will be objectified, documented and made electronically available to share with expert physicians. E.g. long and stressful wait times for a mother and her baby with a suspected heart murmur would become a thing of the past. With eMurmur, objective diagnosis and the option of tele-consultation by sharing the auscultation data will reduce stresses for patients/parents, will improve diagnoses, reduce unnecessary referral rates, reduce pressure on primary care providers, free up specialists’ time for for patients who really need it, and will bring down associated costs in the medical system.