Oulu, Finland, December 10, 2018 – The new waterproof Bittium Faros™ ECG devices, Bittium Cardiac Navigator™ and Bittium Cardiac Explorer™
analysis software received FDA 510(k) medical device clearances in
United States. The FDA 510(k) clearance received by the Bittium Faros
ECG device includes the built-in algorithms for detection of
arrhythmias. The algorithms can be used to automatically identify
sequences in the heart measurement data that include atrial
fibrillation, tachycardia, bradycardia, and pauses in the operation of
the heart. The received FDA 510(k) clearance also allows the use of
Bittium Faros ECG measuring devices for pediatric ECG measurements.
addition, the received clearance allows the use of Bittium Faros either
in long-term ECG recording or in remote wireless cardiac monitoring. In
the recording mode, the ECG measurement data is stored in the memory
card of the device and it is transferred to the computer for analysis
using the USB connection. In the remote recording mode, in addition to
storing the ECG measurement data in the memory card, it is transmitted
wirelessly over Bluetooth to a wireless terminal and forwarded to a
cloud service, which can be, for example, an analysis and monitoring
service provided by Bittium’s customer.
received FDA 510(k) clearance allows cardiologists to use the Bittium
Cardiac Navigator and Bittium Cardiac Explorer software solutions for
official analysis of ECG-recordings collected with the Bittium Faros ECG
monitoring devices. Based on recordings, the software provides
information about the electrical cardiac activity of the heart, and in
particular, about arrhythmia and other exceptional events. Bittium
Cardiac Explorer offers a quick and flexible way of working with
event-based ECG arrhythmia analysis. Bittium Cardiac Navigator is
designed for scanning longer measurements efficiently in a shorter time
and thus speeding up the final diagnosis.
previous Bittium Faros product family had FDA 510(k) clearance for ECG
monitoring, recording and wireless transfer of data, as well as
evaluation of monitored ECG information.
Bittium Faros product family and analysis software
Bittium Faros is
a versatile waterproof ECG device that is used for early detection of
cardiac abnormalities in everyday life. Bittium Faros is ultra-small and
lightweight, which enables precise long-term full disclosure ECG
measurements for long-term Holtering, cardiac event monitoring, mobile
cardiac telemetry and assessing autonomic nervous system functions.
Faros outpatient monitoring solutions include several software options
for cardiac monitoring. The built-in arrhythmia detection algorithms of
Bittium Faros device are used for event recording and cardiac event
monitoring. Bittium’s solutions enable earlier repatriation of patients
and better ability to react to potentially emerging arrhythmias faster.
Bittium Cardiac Navigator is
a completely new type of solution for the analysis of clinical Holter
ECG recordings. Its user-friendly and informative data presentation and
intuitive analysis tools make the software efficient and easy to use
when analyzing multiple days of ECG recordings. Bittium Cardiac
Navigator is designed for scanning longer measurements efficiently in a
shorter time and thus speeding up the final diagnosis.
Bittium Cardiac Explorer
offers a quick and flexible way of working with event-based ECG
arrhythmia analysis. The biggest benefits of the software are having
full disclosure ECG always available, full access to the events
identified by the device, total control of the reporting content and the
ability to analyze an unlimited amount of measurement data.
More information on the offering: https://www.bittium.com /medical