FDA clears next-generation AI-powered ECG monitoring device
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Key takeaways:
- The FDA cleared a next-generation AI-powered remote ECG monitoring device.
- The Bluetooth-enabled device requires no patient intervention and can communicate to physicians via cellular networks.
InfoBionic announced it received FDA 510(k) clearance for its next-generation remote ECG monitoring device with a Bluetooth diagnostic six-lead sensor for patients who require cardiac monitoring.
In a previous prospective, nonrandomized trial, researchers evaluated data from 1,003 adults from multiple sites with risk factors for stroke and no known AF and wore a continuous ambulatory heart rhythm monitor (MoMe) for up to 30 days.
Image: Adobe Stock
As Healio previously reported, the AI algorithm, when applied to existing ECGs in adults at high risk for stroke, identified signs of AF risk during normal sinus rhythm.
This next-generation device (MoMe ARC) features a decoupled two-channel, six-lead sensor and is capable of connecting to other Bluetooth-enabled health monitoring devices, according to a company press release.
ECG data is transmitted in near-real time; analyzed by the AI algorithm platform; and, when indicated, is flagged for clinician review, according to the release.
This process requires no patient intervention; however, it does display a patient event trigger and symptom description on a new screen, similar to a smartwatch, according to the release.
“MoMe ARC is a solution that includes a 4-in-1 Gateway device that seamlessly transitions between 2-day in addition to Extended Holter tests, Event and MCT modes remotely, streamlining patient monitoring time and minimizing delays. In addition, MoMe ARC leverages a comprehensive cloud-based proprietary platform to deliver on-demand, actionable data and analytics directly to the clinicians. Further it incorporates our initial sleek body worn Sensor in a new lightweight form factor which is decoupled from the device Gateway communicating through the latest implementations of Bluetooth connectivity,” Dave MacCutcheon, regulatory and chief operating officer at InfoBionic, said in the release. “The MoMe ARC is designed so patients can wear it discreetly and comfortably during monitoring using standard electrodes. The Sensor is paired to the ARC Gateway which leverages a cellular connection to the MoMe Software Platform empowering physicians to transform the efficiency with which they manage cardiac arrhythmia detection and monitoring processes for their patients.”
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