Angel Medical Systems
Developer of an implantable intracardiac monitoring and patient-alerting system for early detection of acute coronary syndrome (ACS) events. Focus areas include continuous intracardiac electrogram acquisition, machine-learning derived patient-specific ST-shift detection, randomized pivotal clinical trials with independent adjudication, regulatory authorizations for implantable cardiac devices, and payer engagement for coding and reimbursement.
Industries
Nr. of Employees
small (1-50)
Angel Medical Systems
Products
Implantable intracardiac monitoring and alerting system
An implantable monitoring device connected to an active-fixation intracardiac sensing lead that continuously acquires intracardiac electrograms, applies machine-learning derived patient-specific ST-shift detection, stores triggered electrograms for clinician review, and provides internal vibration plus external auditory/visual patient alerts.
Implantable intracardiac monitoring and alerting system
An implantable monitoring device connected to an active-fixation intracardiac sensing lead that continuously acquires intracardiac electrograms, applies machine-learning derived patient-specific ST-shift detection, stores triggered electrograms for clinician review, and provides internal vibration plus external auditory/visual patient alerts.
Services
Reimbursement and coding support
Support for physician and facility reimbursement processes including coding guidance, coverage/payment support, and prior authorization assistance.
Clinical training and implantation support
Onsite and remote clinician education and procedural support covering implantation technique, device programming, follow-up interrogation, and use of device-derived electrogram data in clinical pathways.
Clinical trial operations and core lab coordination
Support for randomized pivotal trials including site oversight, independent ECG and angiographic core labs, clinical events adjudication, and adaptive statistical monitoring.
Post-market data analysis and scientific dissemination
Analysis of post-approval device performance metrics, preparation of scientific presentations and publications, and evidence-generation to inform clinical adoption.
Reimbursement and coding support
Support for physician and facility reimbursement processes including coding guidance, coverage/payment support, and prior authorization assistance.
Clinical training and implantation support
Onsite and remote clinician education and procedural support covering implantation technique, device programming, follow-up interrogation, and use of device-derived electrogram data in clinical pathways.
Clinical trial operations and core lab coordination
Support for randomized pivotal trials including site oversight, independent ECG and angiographic core labs, clinical events adjudication, and adaptive statistical monitoring.
Post-market data analysis and scientific dissemination
Analysis of post-approval device performance metrics, preparation of scientific presentations and publications, and evidence-generation to inform clinical adoption.
Expertise Areas
- Implantable intracardiac monitoring and patient alerting
- Machine learning for cardiac signal analysis and adaptive thresholding
- Randomized, multi-center clinical trial design and execution
- Bayesian adaptive trial design and interim analysis
Key Technologies
- Intracardiac electrogram (iEGM) monitoring
- Continuous ST-segment deviation detection
- Machine learning–based personalized thresholding
- IS-1 compatible intracardiac sensing lead integration