Digital healthcare firm HeartBeam and Triple Ring Technologies have signed a professional services agreement for the development and design of the former’s portable telehealth solution device for heart attack monitoring.
HeartBeam signed the agreement for its Telehealth complete solution 3D vector Electrocardiogram (ECG) collection device, which is intended to monitor heart attack or myocardial infarction (MI) remotely.
The digital healthcare firm has developed an easy-to-use, personal and portable heart attack detector that can be used at home.
The device is designed to help physicians evaluate whether the cause of chest pain is a heart attack or MI.
It has a Cloud-based software and credit card-sized, reusable 3D vector ECG recording device for providing critical data in real-time to physicians outside of a medical setting.
HeartBeam stated that the collaboration with Triple Ring is a five-phase expedited device development project, which is planned to conclude in the fourth quarter of the year.
The project includes new device builds for verification and validation.
It also includes device packaging and a manufacturing technology transfer to a contract manufacturer.
At present, the company is in talks with many contract manufacturers, with a final choice to be made at a later date.
HeartBeam CEO and founder Branislav Vajdic said: “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.”
The company stated that the new device is scheduled for 510k submission to the US Food and Drug Administration (FDA) in the fourth quarter of the year.