{"id":18274,"date":"2023-11-29T09:04:35","date_gmt":"2023-11-29T09:04:35","guid":{"rendered":"https:\/\/interhospi.com\/?p=18274"},"modified":"2023-11-29T10:07:08","modified_gmt":"2023-11-29T10:07:08","slug":"infobionic-receives-us-fda-clearance-for-its-nextgen-mome-arc-remote-ecg-monitoring-solution","status":"publish","type":"post","link":"https:\/\/interhospi.com\/infobionic-receives-us-fda-clearance-for-its-nextgen-mome-arc-remote-ecg-monitoring-solution\/","title":{"rendered":"InfoBionic receives US FDA clearance for its NextGen MoMe ARC remote ECG monitoring solution"},"content":{"rendered":"
\n

<\/p>\n<\/div><\/section><\/div>

<\/p>\n<\/div><\/section>
\n

InfoBionic receives US FDA clearance for its NextGen MoMe ARC remote ECG monitoring solution<\/h1>\/ in Product News<\/a> <\/span><\/span><\/header>\n<\/div><\/section>
\n

InfoBionic, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for MoMe ARC, their 3rd Generation remote ECG monitoring device paired with their inaugural Bluetooth diagnostic 6-lead sensor designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.<\/h3>\n

<\/p>\n

InfoBionic, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for MoMe ARC, their 3rd Generation remote ECG monitoring device paired with their inaugural Bluetooth diagnostic 6-lead sensor designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.<\/p>\n

Dave MacCutcheon, Regulatory and Chief Operating Officer at InfoBionic, noted that \u201cMoMe 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.<\/p>\n<\/div><\/section>
\n

\n
<\/span><\/span><\/div>
\n
<\/a><\/div><\/div><\/div>
\n
<\/span><\/span><\/div>
\n

\u201cFurther it incorporates our initial sleek body worn sensor in a new lightweight form factor which is decoupled from the device Gateway communicating<\/p>\n

through the latest implementations of Bluetooth connectivity and ushers in a new era of wearability convenience yet maintains the ECG quality of a multi-lead tracing thus bringing convenience and quality together for the first time.<\/p>\n

\u201cThe MoMe ARC is designed so patients can wear it discretely 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.\u201d<\/p>\n<\/div><\/section>
\n

<\/span><\/span><\/div>
\n
<\/a><\/div><\/div><\/div>
\n
<\/span><\/span><\/div>
\n

This device builds on the market success of innovative MoMe Kardia II by providing a decoupled 2-channel \u2013 6-lead sensor. Added foundational technologies make the device capable of connecting to other Bluetooth enabled health monitoring devices.<\/p>\n

K230265 is cleared for use under Product Code DSI \u2013 Arrhythmia Detector and Alarm (including ST-Segment Measurement and Alarm). The ECG data is transmitted in near-real time and analyzed by the MoMe software platform via a suite of robust server-based algorithms; and when indicated, data identified by these algorithms is flagged for clinician review. MoMe ARC requires no patient intervention to capture or analyze data, however it does provide a patient event trigger and symptom description selection through a new screen similar to that of a smart watch.<\/p>\n

For more information, visit: https:\/\/InfoBionic.com<\/a>
\nDigital issue: Please click here<\/a> for more information<\/p>\n<\/div><\/section>
\n

\n