Cable-Free Synthesized ECG
Practice Areas
Challenge
HeartBeam sought to develop a personal, cable-free, and easy-to-use cardiac monitoring solution for in-clinic and at-home use by patients, enabling physicians to assess where vague cardiac symptoms warrant additional diagnostic testing or treatment. Our objective was to create a credit card-sized, ECG recording device that leverages vectorcardiography (VECG) and is integrated with cloud-based software to deliver critical data to physicians in real-time.
Outcomes
The HeartBeam-Triple Ring collaboration produced a personal, cable-free synthesized 12L ECG solution that empowers patients to record synthesized 12L ECG data at home. The device was integrated with a smartphone application to communicate with the HeartBeam Cloud where synthesized 12-lead ECGs are overlaid with baseline data. Physicians are now able to remotely view results and direct next steps for patients in the comfort of their own home. This multidisciplinary and fast-paced program resulted in a 510(k) submission to FDA, and clearance in 2024 for the hardware that leverages vectorcardiography and collects 3D ECG, while the synthesized 12L ECG algorithm is pending FDA clearance.
Value Propositions
- Comprehensive product development, including early R&D, industrial design, product development, manufacturing, and regulatory approval
- Relevant and specific expertise in wearable medical device design
- Regulatory and manufacturing support, including preparation for a 510(k) submission and design transfer
- Variable resources applied just-in-time
Cable-Free Synthesized ECG
Challenge
HeartBeam sought to develop a personal, cable-free, and easy-to-use cardiac monitoring solution for in-clinic and at-home use by patients, enabling physicians to assess where vague cardiac symptoms warrant additional diagnostic testing or treatment. Our objective was to create a credit card-sized, ECG recording device that leverages vectorcardiography (VECG) and is integrated with cloud-based software to deliver critical data to physicians in real-time.
Outcomes
The HeartBeam-Triple Ring collaboration produced a personal, cable-free synthesized 12L ECG solution that empowers patients to record synthesized 12L ECG data at home. The device was integrated with a smartphone application to communicate with the HeartBeam Cloud where synthesized 12-lead ECGs are overlaid with baseline data. Physicians are now able to remotely view results and direct next steps for patients in the comfort of their own home. This multidisciplinary and fast-paced program resulted in a 510(k) submission to FDA, and clearance in 2024 for the hardware that leverages vectorcardiography and collects 3D ECG, while the synthesized 12L ECG algorithm is pending FDA clearance.
Value Propositions
- Comprehensive product development, including early R&D, industrial design, product development, manufacturing, and regulatory approval
- Relevant and specific expertise in wearable medical device design
- Regulatory and manufacturing support, including preparation for a 510(k) submission and design transfer
- Variable resources applied just-in-time
Practice Areas
Background
HeartBeam collaborated with Triple Ring to design their innovative telehealth solution. The joint effort encompassed a five-phase expedited device development program, including device builds for design verification and validation, device packaging, and manufacturing technology transfer. HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company is creating the first-ever cable-free device capable of collecting ECG signals in 3D, from three non-coplanar directions, and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management.
