HeartBeam
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- -
- Employees
- 15
- Market Cap
- -
- Introduction
HeartBeam, Inc. is a development stage company, which engages in cardiovascular diagnostic technology. Its electrocardiogram (ECG) collection device provides physicians with cardiac diagnostic information for a patient that is outside of a medical institution. The device sends ECG signals to the patient's smartphone and on to a cloud-based software expert system. The company was founded by Branislav Vajdic in 2015 and is headquartered in Santa Clara, CA.
Beam Therapeutics' BEAM-101 Shows Promise in Sickle Cell Disease Trial
• Beam Therapeutics will present updated data from the BEACON Phase 1/2 trial of BEAM-101 for sickle cell disease at the 2025 Tandem Meetings.
• BEAM-101 demonstrated robust increases in fetal hemoglobin and reductions in sickle hemoglobin in treated patients.
• The therapy's safety profile aligns with expectations for busulfan conditioning and autologous hematopoietic stem cell transplantation.
• Beam Therapeutics anticipates dosing 30 patients in the BEACON trial by mid-2025 and presenting updated data.
HeartBeam Submits FDA Application for 12-Lead ECG Synthesis Software
• HeartBeam has submitted a 510(k) application to the FDA for its 12-lead ECG synthesis software, designed to assess various cardiac rhythms and arrhythmias.
• The submission is supported by data from the VALID-ECG pivotal study, involving 198 patients across five clinical sites, demonstrating clinical equivalence to standard ECGs.
• The software synthesizes signals from three directions into a 12-lead ECG, using a personalized transformation matrix, for convenient cardiac monitoring.
• Future advancements include AI-based classification algorithms and heart attack detection, aiming to reduce 'symptom to door' times for patients.
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