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December 10, 2018

New waterproof Bittium Faros™ ECG device, Bittium Cardiac Navigator™ and Bittium Cardiac Explorer™ analysis software received FDA 510(k) medical device clearance in United States

Press release

Free for publication on December 10, 2018 at 1.30pm (CET +1)

New waterproof Bittium Faros™ ECG device, Bittium Cardiac Navigator™ and Bittium Cardiac Explorer™ analysis software received FDA 510(k) medical device clearance in United States

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.

In 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.

The 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.

The 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.
Bittium 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

Further information:

Arto Pietilä
Senior Vice President, Medical Technologies
Tel. +358 40 344 3507

Distribution:
Main media

Bittium

Bittium specializes in the development of reliable, secure communications and connectivity solutions, leveraging its 30 year legacy of expertise in advanced radio communication technologies. Bittium provides innovative products and services, customized solutions based on its product platforms and R&D services. Bittium also offers healthcare technology products and services for the measurement and monitoring of biosignals in the areas of cardiology, neurology, rehabilitation, occupational health and sports medicine. Net sales in 2017 were EUR 51.6 million. Bittium is listed on Nasdaq Helsinki. www.bittium.com