US-based cardiac technology company HeartBeam has entered a deal with Evolve Manufacturing Technologies to develop the AIMIGo 3D vector electrocardiogram (VECG) recording device for remote heart attack detection.
The new credit card-sized AIMIGo 3D VECG device offers a 12-lead ECG readout.
Under the deal terms, HeartBeam will use the manufacturing and packaging knowledge of Evolve to commercialise the new device with early market testing expected in the second quarter of next year.
US Food and Drug Administration (FDA) clearance for the device is expected early next year.
HeartBeam developed the AIMIGo device as a personal, portable and simple-to-use heart attack detection system that can be used by patients anytime and anywhere.
The device is intended to support patients and clinicians in determining if symptoms might be the result of a heart attack.
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The solution comprises a credit card-sized, reusable, 3D vector ECG recording device and cloud-based software that transmits vital data 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 offers end-to-end contract manufacturing services for medical device and life sciences instrument firms.
It also provides medical device makers with ISO-certified turnkey contract manufacturing.