HeartBeam submits FDA application for AIMIGo System
- HeartBeam (NASDAQ:BEAT) has submitted a marketing application to the FDA for its HeartBeam AIMIGo System.
- The AIMIGo System is a personal, portable VECG solution for assessing cardiac symptoms.
- It utilizes a reusable VECG recording device and cloud-based software to provide real-time data to clinicians.
- The system aims to assist patients and clinicians outside of medical settings.
- Over 127 million Americans have cardiovascular disease, making this technology significant.
- HeartBeam CEO, Branislav Vajdic, considers the 510(k) submission a milestone.
- The company is proud of its team's efforts and looks forward to FDA collaboration.
- Clinical studies are underway to evaluate the system's ability to synthesize a 12-lead ECG.
- HeartBeam recently secured a $26.5 million capital raise to support their activities and FDA submissions.
- Press Release