InfoBionic secures FDA 510(k) clearance for MoMe ARC

InfoBionic secures FDA 510(k) clearance for MoMe ARC

Time Stamp: October 13, 2023 6:59 AM
Source Node: 2936711

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Following FDA approval, the MoMe ARC is expected to make its market debut in the fourth quarter of 2023. Credit: JHVEPhoto/Shutterstock

The virtual telemetry company, InfoBionic, has received US Food and Drug Administration (FDA) 510(k) clearance MoMe ARC solution.

The MoMe ARC incorporates a remote Electrocardiography (ECG) monitoring device and an initial Bluetooth diagnostic 6-lead sensor, to aid clinicians in their diagnosis of cardiac arrhythmias in patients with a need for cardiac monitoring.

It transmits ECG data in near-real-time, analysed by the MoMe software platform’s server-based algorithms, ensuring timely and accurate identification of crucial data for clinician review.

InfoBionic also claims the device is designed so patients can wear it discretely and comfortably during monitoring using standard electrodes.

Dave MacCutcheon, the Chief Operating Officer, said: “We’re thrilled to announce FDA 510(k) clearance to market the MoMe ARC solution, which supports our mission to create superior patient monitoring solutions for arrhythmia detection and virtual care and chronic disease management.”

This device builds on its predecessor, the MoMe Kardia II, by introducing a decoupled 2-channel – 6-Lead Sensor, equipped with foundational technologies for compatibility with other Bluetooth-enabled health monitoring devices.

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Macutheon added: “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.”

Following FDA approval, the MoMe ARC is expected to make its market debut in the fourth quarter of 2023.

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