InfoBionic.Ai Earns FDA Clearance for its MoMe ARC Patch

The U.S. Food and Drug Administration (FDA) has awarded 510(k) clearance to InfoBionic.Ai’s MoMe ARC 1-Lead Patch, an added configuration for extended-duration ECG monitoring.

Designed to seamlessly work with the existing MoMe ARC platform, the new patch enables extended remote ECG monitoring with just one lightweight, flexible, disposable patch. Clinicians can now deploy the MoMe ARC system in single-lead patch form without changing out hardware or workflows, simply by connecting the sensor into the new disposable patch.

“The MoMe ARC Patch is more than just a device. It’s a strategic milestone,” InfoBionic.Ai CEO Stuart Long stated. “It reflects our long-term vision for a modular, intelligent monitoring platform that quickly delivers AI-informed, clinical-grade ECG data to providers, enabling them to provide better care to patients.”

The MoMe ARC Patch offers the same continuous, high-quality near-real-time ECG monitoring services while giving the physician the ability to customize the configuration of the MoMe ARC system to fit a patient’s needs and maximize care and outcomes. Use of the MoMe ARC Patch can dramatically reduce the setup burden for practice staff and reduce required patient interaction with the MoMe ARC system, according to the company. Its flexible materials maximize patient comfort and adherence, and its extended battery life allows patients to wear the patch for extended periods without charging the sensor, while still maintaining connectivity for near-real-time analysis of ECG.

With this product launch, InfoBionic.Ai is building on its MoMe ARC vision: a scalable, AI-enabled solution that meets patients where they are—in the hospital, at home, or on the go. The MoMe ARC is the system’s intelligent core, providing artificial intelligence-enhanced data analysis and seamless integration with a growing suite of sensors, including the original six-lead configuration and now the one-lead patch configuration.

“This product evolution reflects our belief that innovation should never come at the cost of clinical accuracy,” Long said. “We’re empowering providers with more flexible options while delivering consistent, trusted data that can drive smarter decisions and better outcomes.”

InfoBionic.Ai’s digital technology aims to transform cardiac remote patient monitoring efficiency and economics. The company’s vision for its FDA-cleared third-generation platform, the MoMe ARC, is to remove the roadblocks hindering virtual and remote diagnosis and decision-making. The Massachusetts-based team of seasoned entrepreneurs has had successful careers in healthcare, IT, medical devices, and mobile technology, and brings specific expertise in remote monitoring and cardiology.