Periodic Reporting for period 2 - SCAUT DECISIO (Preventive and Personalised Remote Care for Heart Patients)
Okres sprawozdawczy: 2021-07-01 do 2022-06-30
There is no cure for chronic heart disease. Each year, 8 million people die of sudden cardiac arrest caused by untreated arrhythmia. Even when chronic heart patients have cardiac implanted electronic devices (CIEDs), they still experience life-threatening arrhythmia which dramatically lower their quality of life and leads to early deaths. Today, hospitals carry out remote patient monitoring to follow-up on these life-threatening situations. However, all existing remote patient monitoring systems are disease-oriented and designed for reactive care, where intervention is carried out after a cardiac arrhythmia has occurred. There is thus a major unmet need for a solution which can predict and thereby prevent life-threatening arrhythmia for cardiac patients.
Our vision is to change what it means to be a chronic heart patient by introducing advanced software platforms that help patients live longer and better lives. To do so, we are currently developing the first patient-centered, AI-driven clinical decision-support tool for preventing life-threatening arrhythmia in CIED patients. By combining patient-clinician communication with predictive AI algorithms, we can effectively and efficiently predict life-threatening arrhythmias, thereby allowing early and appropriate interventions to be taken. This will lower the number of CIED patients experiencing life-threatening arrhythmia – and eventual death. We aim to improve both the quality of care for patients and reduce healthcare costs.
Our overarching goal is to revolutionize chronic care and finally enable truly personalized and preventive care for chronic heart patients all across the world.
Our vision is to change what it means to be a chronic heart patient by introducing advanced software platforms that help patients live longer and better lives. To do so, we are currently developing the first patient-centered, AI-driven clinical decision-support tool for preventing life-threatening arrhythmia in CIED patients. By combining patient-clinician communication with predictive AI algorithms, we can effectively and efficiently predict life-threatening arrhythmias, thereby allowing early and appropriate interventions to be taken. This will lower the number of CIED patients experiencing life-threatening arrhythmia – and eventual death. We aim to improve both the quality of care for patients and reduce healthcare costs.
Our overarching goal is to revolutionize chronic care and finally enable truly personalized and preventive care for chronic heart patients all across the world.
• We have finished WP 1, which main goal has been to mature the AI-driven clinical decision-support tool to enable early intervention using predictive analytics. We have done this by automating ECG assessment and by providing clinicians with a holistic view of the patients’ status. We now suggest medical diagnoses based on the morphology of the heart rhythms in our platform. We have drawn on several competencies within the team to reach this milestone, both within data science, software engineering and design. All the deliverables and milestones have been completed.
• We have finished WP2 by extending our capabilities to interpret device transmissions from all cardiac device types and manufacturers to become fully device agnostic. In addition, we have accomplished a fully automated onboarding flow for patients, and support provision per-customer isolated and secure deployment. Furthermore, we now have a functioning EHR integration using the SMART on FHIR protocols.
• We obtained regulatory approval in accordance with Medical Device Directive 93/42/EEC, Annex VII.
• In obtaining our CE-mark and during the regulatory audit, we presented the clinical documentation, which was found to be enough documentation in terms of establishing enough trust in the results and potential side effects of our product, which was the intention with WP 3.
• As for the plan to become regulatory compliant for the coming changes from MDD to MDR in 2024, we have started working with our regulatory consultants to engage. The necessary documents for the clinical evaluation will be in place during 2023, in time to be part of the basis for MDR compliance.
• We have finished WP4 as we can conclude on the management of the project, that all milestones and deliverables have been completed. We periodically reviewed the risk table and managed unforeseen risks, as described in the Periodic Report.
• We have finished WP2 by extending our capabilities to interpret device transmissions from all cardiac device types and manufacturers to become fully device agnostic. In addition, we have accomplished a fully automated onboarding flow for patients, and support provision per-customer isolated and secure deployment. Furthermore, we now have a functioning EHR integration using the SMART on FHIR protocols.
• We obtained regulatory approval in accordance with Medical Device Directive 93/42/EEC, Annex VII.
• In obtaining our CE-mark and during the regulatory audit, we presented the clinical documentation, which was found to be enough documentation in terms of establishing enough trust in the results and potential side effects of our product, which was the intention with WP 3.
• As for the plan to become regulatory compliant for the coming changes from MDD to MDR in 2024, we have started working with our regulatory consultants to engage. The necessary documents for the clinical evaluation will be in place during 2023, in time to be part of the basis for MDR compliance.
• We have finished WP4 as we can conclude on the management of the project, that all milestones and deliverables have been completed. We periodically reviewed the risk table and managed unforeseen risks, as described in the Periodic Report.
Vital Beats collects, processes and analyses a vast amount of dynamic information to offer clinicians a complete clinical picture with all relevant information to support optimal clinical decision-making. The SCAUT DECISIO platform thus represents a revolutionary digital health intervention platform that addresses the limitations of existing remote patient monitoring systems through the following unique selling points:
• Arrhythmia prediction and prevention: through its AI-driven analysis of multimodal data, SCAUT DECISIO automatically alerts clinicians before cardiac diseases progress to a more dangerous state, thereby enabling clinicians to take timely interventions and thus to prevent premature deaths.
• Seamless patient inclusion: SCAUT DECISIO enables fast and efficient two-way communication between clinicians and patients. The additional information provided by patients contributes to a complete clinical profile which clinicians can use to make optimal clinical decisions. Also, patients are fully included in their disease management via our patient app, allowing them to live more independent and untroubled lives.
• Compatible with all cardiac devices: SCAUT DECISIO is fully compatible with all major CIED vendors to ensure access for every patient and every clinic. As it is very common that a patient over time needs a re-implantation, and they rarely get a CIED from the same vendor, a lot of confusion is created for the patient while clinicians are forced to look in several CIED systems to get all biometric data of the patient. SCAUT DECISIO ensures the workflow for clinicians remains unchanged and removes any confusion for patients.
• Efficient clinical administration: the reports generated by SCAUT DECISIO are automatically integrated into EHRs of hospitals, thus alleviating the administrative burden of manual registration of patient records by clinicians that is currently practiced in clinics. In this way, SCAUT DECISIO prevents overloading clinicians with data and allows them to spend more time on more demanding and critical tasks at hand
• Arrhythmia prediction and prevention: through its AI-driven analysis of multimodal data, SCAUT DECISIO automatically alerts clinicians before cardiac diseases progress to a more dangerous state, thereby enabling clinicians to take timely interventions and thus to prevent premature deaths.
• Seamless patient inclusion: SCAUT DECISIO enables fast and efficient two-way communication between clinicians and patients. The additional information provided by patients contributes to a complete clinical profile which clinicians can use to make optimal clinical decisions. Also, patients are fully included in their disease management via our patient app, allowing them to live more independent and untroubled lives.
• Compatible with all cardiac devices: SCAUT DECISIO is fully compatible with all major CIED vendors to ensure access for every patient and every clinic. As it is very common that a patient over time needs a re-implantation, and they rarely get a CIED from the same vendor, a lot of confusion is created for the patient while clinicians are forced to look in several CIED systems to get all biometric data of the patient. SCAUT DECISIO ensures the workflow for clinicians remains unchanged and removes any confusion for patients.
• Efficient clinical administration: the reports generated by SCAUT DECISIO are automatically integrated into EHRs of hospitals, thus alleviating the administrative burden of manual registration of patient records by clinicians that is currently practiced in clinics. In this way, SCAUT DECISIO prevents overloading clinicians with data and allows them to spend more time on more demanding and critical tasks at hand