HeartBeam (Nasdaq: BEAT) said today that it has signed a professional services agreement with Triple Ring Technologies to help develop and design its personal, portable heart attack detector.
Santa Clara, California-based HeartBeam said it plans to submit what it calls a “telehealth complete solution 3D vector electrocardiogram (ECG) collection device” for FDA 510(k) clearance in the fourth quarter of 2022.
The company said patients will be able to use the credit-card-sized device at home to help their doctors determine whether chest pain is due to a myocardial infarction (the medical term for a heart attack) using cloud-based software for real-time data transmission.
The project includes device builds for design verification and validation, device packaging and a manufacturing technology transfer. HeartBeam said it is talking with several contract manufacturers.
“The joint effort will be a five-phase expedited device development project to rapidly build and test our 3D vector collection device.” HeartBeam founder and CEO Branislav Vajdic said in a news release. “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.”
HeartBeam said in December that it’s aiming for FDA clearance and a limited market release in the first quarter of 2023 and a product launch in the following quarter. The company also said it plans to submit an emergency room software tool for the detection of myocardial infarction for FDA clearance in the second quarter with anticipated clearance and limited release in the third quarter.
Triple Ring is headquartered in Newark, California, and has offices in Boston, Toronto, and Copenhagen. The co-developer works with medtech and life sciences firms on early R&D, product development, manufacturing, regulatory approval, market access, strategic investment and incubation.