BEAT - HeartBeam submits FDA application for AIMIGo System

2023-05-18 09:11:02 ET

• 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 their 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

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