Periodic Reporting for period 1 - eMurmur (eMurmur, a software based, clinically tested medical device for automated heart murmur detection)
Période du rapport: 2015-07-01 au 2015-10-31
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.
• 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