BEAT - HeartBeam to file FDA submissions for telehealth solutions in early 2023

• MedTech company HeartBeam, Inc ( NASDAQ: BEAT ) announced Thursday that it will start filing for its version 1 and version 2 HeartBeam AIMIGo telehealth solutions in early 2023.
• The company, which offers ECG-based telemedicine technology for heart attack detection, filed a so-called 510(k) application in Q2 2022 seeking an FDA nod for HeartBeam AIMI platform technology.
• Issuing a shareholder letter, HeartBeam’s ( BEAT ) CEO Branislav Vajdic said that the company expects an FDA submission for HeartBeam AIMIGo Version 1 in Q1 2023 and another filing for HeartBeam AIMIGo Version 2 device will be ready by the end of Q2 2023.
• “We are leveraging our strategic partnerships with multiple industry leaders to move toward production and commercialization of our products, with plans to broaden our product portfolio pipeline with smartwatch connectivity,” he added.
• In November, HeartBeam ( BEAT ) planned to complete the FDA submission for HeartBeam AIMIGo V1 and V2 in Q4 2022 and Q2 2023, respectively.

For further details see: