Under the agreement, HeartBeam will make use of the manufacturing and packaging expertise of Evolve Manufacturing to commercialise the AIMIGo device in anticipation of early market testing in Q2 2023
The AIMIGo 3D VECG device offers a 12-lead ECG readout for heart detection from anywhere. (Credit: Towfiqu barbhuiya on Unsplash)
US-based cardiac technology company HeartBeam has inked an agreement with contract medical device manufacturing firm Evolve Manufacturing Technologies to develop AIMIGo 3D vector electrocardiogram (VECG) recording device for remote heart detection.
The credit card-sized AIMIGo 3D VECG device is said to offer a 12-lead ECG readout.
According to the terms of the agreement, HeartBeam will make use of the manufacturing and packaging expertise of Evolve Manufacturing to commercialise the device for expected early market testing in Q2 2023.
HeartBeam is also expecting US Food and Drug Administration (FDA) clearance early next year.
The AIMIGo device is designed as a personal, portable, and simple-to-use heart attack detection system that can be utilised by patients anytime and anywhere. It is intended to aid patients and their clinicians determine if symptoms might be the result of a heart attack.
The cardiac technology firm said that the reusable, credit card-sized, 3D vector ECG recording device which uses cloud-based software, transmits vital information to clinicians in real-time outside of a medical setting.
HeartBeam CEO and founder Branislav Vajdic said: “Evolve has deep medical device manufacturing expertise and a strong reputation in the industry for delivering consistent product quality and customer care rarely found in medical contract manufacturers.
“Evolve’s dedicated customer teams use Design for Excellence (DFX) methodologies, and state-of-the-art, end-to-end quality processes, plus world-class materials suppliers to ensure consistent and high-quality products.
“We have now begun technology transfer from Triple Ring Technologies to Evolve as they develop and obtain experience with our product in preparation for manufacturing.”
Evolve Manufacturing, which is based in Silicon Valley, offers end-to-end contract manufacturing services for medical device and life sciences instrument firms. The contract manufacturing firm also provides medical device makers with ISO-certified turnkey contract manufacturing.
Previously, Evolve Manufacturing and Triple Ring Technologies, which is HeartBeam’s co-developer of the AIMIGo device, worked together to create additional synergies as the device transitions into manufacturing technology transfer.