Michael Barbella, Managing Editor04.28.22
HeartBeam Inc. is teaming up with Triple Ring Technologies Inc. to design and develop a telehealth complete solution 3D vector Electrocardiogram (ECG) collection device for remote heart attack or myocardial infarction (MI) monitoring. The joint partnership is a five-phase expedited device development project scheduled to be completed in the fourth quarter for a 510k submission to the U.S. Food and Drug Administration.
HeartBeam has developed a personal, portable and easy-to-use heart attack detection solution that can be used by patients at home to help their physicians assess whether chest pain is the result of a heart attack or MI. HeartBeam’s breakthrough solution employs a reusable, credit card sized, 3D vector ECG recording device and cloud-based software to deliver critical data to physicians real-time outside of a medical setting. More than 18 million people in the United States have coronary artery disease and every 40 seconds someone in the United States has a heart attack, or MI.
“Our technology partnership with Triple Ring will allow us to rapidly advance commercial production capabilities of our 3D vector collection device, with the project scheduled to complete in time for a 510k submission to the FDA in the fourth quarter of this year. We look forward to working with the team at Triple Ring to leverage their scientific capabilities, medical device technology expertise and commercialization know-how to successfully compete the project,” said Branislav Vajdic, Ph.D., CEO and founder of HeartBeam.
Triple Ring is a company that works with small and large medtech firms on co-developing successful medical technologies in the marketplace. Capabilities span early R&D, product development, manufacturing, regulatory approval, market access, strategic investment and incubation.
“Triple Ring is pleased to partner with HeartBeam to develop the integral medical device that is part of their complete Telehealth solution for the detection of heart attacks outside of a medical institution,” said Joe Heanue, CEO of Triple Ring Technologies. “We look forward to contributing our capabilities and experience to the HeartBeam team to help turn their innovative science into commercial and business success.”
Under the terms of a joint develoment agreement, the project will include HeartBeam telehealth 3D vector ECG collection device builds for design verification and validation, device packaging, and a manufacturing technology transfer to a contract manufacturer to be named later. HeartBeam is currently in discussions with several contract manufacturers.
“Triple Ring has a long history of designing a wide variety of medical devices and underlying technologies, and we are pleased to be working with its medical device team for our telehealth device,” said Vajdic. “The joint effort will be a five-phase expedited device development project to rapidly build and test our 3D vector collection device. Patients place this credit card sized device on their chest for a 30 second signal ECG recording, capturing the heart’s electrical activity from three angles in 3D by recording 3 (xyz) projections of the heart vector. A smartphone application connected to the device communicates with the HeartBeam cloud for a diagnostic suggestion and synthesized 12-lead ECG overlaid with baseline. A physician can then remotely view the results through an online portal and can direct the next steps for the patient."
Triple Ring Technologies is a co-development company headquartered in Silicon Valley, with offices in Boston, Toronto, and Copenhagen. It partners with clients in medtech, life sciences, and sustainability and the environment to create new technologies, launch projects, and start new ventures. Their capabilities span early R&D, product development, manufacturing, regulatory approval, market access, strategic investment, and incubation.
HeartBeam Inc. is a development stage digital healthcare company with proprietary ECG telemedicine technology that seeks to redefine the way high-risk cardiovascular patients are diagnosed in an ambulatory setting. Its solution employs a reusable, credit card sized, 3D vector ECG recording device and cloud-based software capable of assisting a physician in diagnosing a wide range of cardiovascular disease. HeartBeam is initially focusing on helping diagnose heart attacks in patients outside of a medical institution. No single lead ECG technology can offer this value to patients and their physicians. This underserved market is several times larger than the cardiac arrhythmia detection market based on the prevalence of patients with coronary artery disease at high risk of heart attack.
HeartBeam has developed a personal, portable and easy-to-use heart attack detection solution that can be used by patients at home to help their physicians assess whether chest pain is the result of a heart attack or MI. HeartBeam’s breakthrough solution employs a reusable, credit card sized, 3D vector ECG recording device and cloud-based software to deliver critical data to physicians real-time outside of a medical setting. More than 18 million people in the United States have coronary artery disease and every 40 seconds someone in the United States has a heart attack, or MI.
“Our technology partnership with Triple Ring will allow us to rapidly advance commercial production capabilities of our 3D vector collection device, with the project scheduled to complete in time for a 510k submission to the FDA in the fourth quarter of this year. We look forward to working with the team at Triple Ring to leverage their scientific capabilities, medical device technology expertise and commercialization know-how to successfully compete the project,” said Branislav Vajdic, Ph.D., CEO and founder of HeartBeam.
Triple Ring is a company that works with small and large medtech firms on co-developing successful medical technologies in the marketplace. Capabilities span early R&D, product development, manufacturing, regulatory approval, market access, strategic investment and incubation.
“Triple Ring is pleased to partner with HeartBeam to develop the integral medical device that is part of their complete Telehealth solution for the detection of heart attacks outside of a medical institution,” said Joe Heanue, CEO of Triple Ring Technologies. “We look forward to contributing our capabilities and experience to the HeartBeam team to help turn their innovative science into commercial and business success.”
Under the terms of a joint develoment agreement, the project will include HeartBeam telehealth 3D vector ECG collection device builds for design verification and validation, device packaging, and a manufacturing technology transfer to a contract manufacturer to be named later. HeartBeam is currently in discussions with several contract manufacturers.
“Triple Ring has a long history of designing a wide variety of medical devices and underlying technologies, and we are pleased to be working with its medical device team for our telehealth device,” said Vajdic. “The joint effort will be a five-phase expedited device development project to rapidly build and test our 3D vector collection device. Patients place this credit card sized device on their chest for a 30 second signal ECG recording, capturing the heart’s electrical activity from three angles in 3D by recording 3 (xyz) projections of the heart vector. A smartphone application connected to the device communicates with the HeartBeam cloud for a diagnostic suggestion and synthesized 12-lead ECG overlaid with baseline. A physician can then remotely view the results through an online portal and can direct the next steps for the patient."
Triple Ring Technologies is a co-development company headquartered in Silicon Valley, with offices in Boston, Toronto, and Copenhagen. It partners with clients in medtech, life sciences, and sustainability and the environment to create new technologies, launch projects, and start new ventures. Their capabilities span early R&D, product development, manufacturing, regulatory approval, market access, strategic investment, and incubation.
HeartBeam Inc. is a development stage digital healthcare company with proprietary ECG telemedicine technology that seeks to redefine the way high-risk cardiovascular patients are diagnosed in an ambulatory setting. Its solution employs a reusable, credit card sized, 3D vector ECG recording device and cloud-based software capable of assisting a physician in diagnosing a wide range of cardiovascular disease. HeartBeam is initially focusing on helping diagnose heart attacks in patients outside of a medical institution. No single lead ECG technology can offer this value to patients and their physicians. This underserved market is several times larger than the cardiac arrhythmia detection market based on the prevalence of patients with coronary artery disease at high risk of heart attack.