InfoBionic, Inc. today announced that it
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. “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,” said Dave MacCutcheon,
Regulatory and Chief Operating Officer at InfoBionic.
MacCutcheon further points out that
“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
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. The 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.”
This next generation device builds on the market
success of innovative MoMe® Kardia II by providing a decoupled
2-channel – 6-Lead Sensor. Added foundational technologies make the device
capable of connecting to other Bluetooth enabled health monitoring devices.
K230265 is cleared for use under Product Code DSI -
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.
InfoBionic expects to begin shipping the new
generation MoMe® ARC Device in Q4 2023.
