Header - hero image Bittium in 2023
Bittium in 2023

Medical Business Segment

Products and Services for Biosignal Measuring

In the Medical business segment, Bittium offers its customers medical technology products and services for biosignal measuring in the areas of cardiology, neurology, and sports medicine. Combining medical technologies with Bittium´s long-term experience and competence in wireless and security technologies gives Bittium an excellent basis to serve its customers in the medical sector.

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 full disclosure ECG measurements for long-term holtering, cardiac event monitoring, mobile cardiac telemetry and assessing the autonomic nervous system functions. Bittium Faros outpatient monitoring solutions include several software options for cardiac monitoring. The built-in arrhythmia detection algorithms on the Bittium Faros device are used for event recording and cardiac event monitoring. Bittium’s solutions enable the earlier discharge of patients and the ability to react to detected arrhythmias faster.

Bittium OmegaSnap™ Product Family:
Bittium OmegaSnap™ 1-CH ECG Electrode is the most cost-effective, patient compliant and reliable patch electrode for long-term ECG measurements. It is also suitable for HRV applications and heart monitoring for stroke patients.

Bittium MiniSnap™ Sensitive 1-CH ECG Electrode is the most suitable one-channel electrode for 24h ECG measurements on small adults and children.

Bittium OmegaSnap™ 2-CH ECG Electrode is a two-channel electrode which is the best choice when more than one-channel measurement is needed for more comprehensive arrhythmia analysis while maximizing patient compliance.

Bittium OmegaSnap™ 3-CH ECG Electrode is a three-channel electrode, which is the most patient-compliant way to perform traditional three-channel measurements.

Bittium OmegaSnap™ 1-CH Adapter and Bittium OmegaSnap™ Multi-CH Adapter – Bittium OmegaSnap ECG electrode and Bittium Faros ECG device are connected to each other through the lightweight and discreet Bittium OmegaSnap Adapter. The adapter also allows the Faros device to be temporarily detached from the patch electrode when charging, for example. In the case of remote heart monitoring, such as the Bittium HolterPlus solution, it significantly enhances the long-term use of the same electrode, thus ensuring that the skin contacts of the attached electrode remain optimal for the measurement to continue. There are two adapter versions available: Bittium OmegaSnap 1-CH Adapter is designed for one-channel electrodes, and Bittium OmegaSnap Multi-CH Adapter is designed for two- and three-channel electrodes.

Bittium Cardiac Navigator™ is a completely new software solution for analyzing clinical Holter ECG recordings. Its user-friendly and informative way of presenting data and intuitive analysis tools make it easier and more efficient to analyze ECG measurements lasting several days. Bittium Cardiac Navigator is designed to efficiently go through longer measurements in a short time and thus speed up the final diagnosis.

Bittium HolterPlus™ is a web-based remote cardiac monitoring solution, consisting of a Bittium Faros ECG device and Bittium MedicalSuite mobile application integrated into a secure smart device and Medical Suite remote service platform. Bittium HolterPlus enables remote monitoring and earlier discharge of the patient, and allows the ECG measurement data of the remotely monitored patient to be wirelessly transferred securely from the monitoring device to the Bittium MedicalSuite remote diagnostics service platform. From the platform the ECG recording can be downloaded to a cardiologist for the diagnosis, and the diagnosis will be uploaded for the treating physician for further patient care.

Bittium MedicalSuite™ is an advanced remote monitoring service platform that utilizes wireless data transfer. Bittium Medical Suite is mainly aimed at service providers to facilitate secure information sharing and workflow management between service providers, clinics, and specialists. The Bittium MedicalSuite platform allows specialists to perform remote consultations regardless of location. The Service is a combination of intelligent analysis, wireless data transfer, reporting, and management modules that you can optimize according to your needs. The easy-to-use web user interface allows dashboard customization for different user groups, which ensures effortless workflow and improves efficiency. Currently, the system supports cardiac monitoring services, but the same technology can be applied to any biosignal measurements, such as brain monitoring and home sleep apnea testing services.

Bittium BrainStatus is a wireless compact EEG amplifier, which is used together with a disposable, easy and quick-to-wear Bittium BrainStatus electrode headband, for example, to diagnose epileptic seizures and brain stroke. Bittium BrainStatus enables quick measurement in field conditions as well as in hospitals, thus making the treatment process of the patient faster. Bittium Brain Status can be used for wireless real-time remote EEG monitoring, or data can be recorded to the device memory.

Bittium BrainStatus™ with Cerenion C-Trend® is the world’s first practical method for measuring the brain function of intensive care patients. Bittium BrainStatus measures and monitors the electrical activity in the brain, and with the help of Cerenion C-Trend analysis tool, the brain’s state is displayed as a straight-forward and simple-to-interpret numeric value by making use of machine learning algorithms and artificial intelligence.

Bittium NeurOne™ is one of the quickest and most accurate EEG measuring devices in the world designed for clinical and research use. Bittium NeurOne system enables fully synchronized group measuring of up to 30 persons simultaneously, for example, in different types of psychological studies. The solution is optimized for use with transcranial magnetic stimulators (TMS-EEG), with an optional possibility to use it during magnetic resonance imaging procedures (fMRI-EEG).

Bittium Respiro™ is a modern home sleep apnea test and analysis solution for service providers, hospitals, clinics, and health centers. It is focused on Home Sleep Apnea Testing (HSAT) and intended to record standard PG level data and analyze typical sleep-related breathing disorders, such as obstructive sleep apnea, central sleep apnea, mixed sleep apnea, hypopnea and Cheyne-Stokes breathing.

Bittium Respiro Analyst™ software provides a web-based intuitive user interface which utilizes artificial intelligence to accelerate analysis work. The software pre-analyses the massive amount of measurement data and converts it to a more visual and informative format. This makes it easier and quicker for healthcare personnel to perform further analysis and diagnosis. Bittium MedicalSuite provides the same cloud backend system for all Bittium medical products and services, and enables fast and location-independent data analysis.

Year 2023

A component shortage significantly slowed down the manufacturing and deliveries of medical technology products at the beginning of the year, and the production of Bittium Faros™ ECG devices was very limited for several months. In April-May, production volumes were increased, and the manufacturing of products continued with better capacity in May-June. The deliveries continued in the second quarter as planned, and the shortage of components eased towards the end of the year, as expected. In the second half of the year, the sales of medical technology devices outside of the US market developed slower than estimated. The development of sales is affected by the insurance policies related to treatment reimbursement, which vary between different countries affecting the development pave of remote diagnostics market. In addition, entering new markets is affected by obtaining the medical device regulatory approvals, that may take up to more than a year depending on the approval.

Most product deliveries of Faros ECG devices were still made to the US customer Boston Scientific Cardiac Diagnostics (CDx) (previously known as Preventice). CDx is one of the leading providers of ECG measurement services in the US.

In the neurophysiology market, the piloting of Bittium BrainStatus™ EEG measuring devices in intensive care units continued in Finland and abroad. The change in recommendations for intensive care regarding EEG measurement is expected to have a positive effect on the demand for BrainStatus.

Product deliveries of the home sleep apnea test and measurement solution Bittium Respiro™ continued in Europe, and the feedback from our customers’ clinical trials has been positive. Respiro’s sales are expected to strengthen during the current year and form one significant growth driver in the Medical Business Segment in the future. In November, Bittium and ResMed started a collaboration regarding the distribution of Bittium Respiro to hospitals and treatment centers. The signed distributor agreement concerns the Bittium Respiro™ measuring device and its accessories as well as the Bittium Respiro Analyst™ analysis software and service platform, giving ResMed the right to resell them. The agreement does not include exclusive rights and it covers the right to resell the solution in Great Britain, Ireland, Switzerland, Finland, Norway, and Sweden. ResMed is a leading provider of cloud-based medical devices whose solutions are transforming the care of people with sleep apnea, COPD, and other chronic respiratory diseases.

Bittium is applying for a sales license for Respiro for the US market from the Food and Drug Administration (FDA). The current estimate of the amount of work and the time needed for it is at least one year. The requirements of the FDA authority have grown and become stricter in recent years. The overall duration of the sales license process is affected by the authority’s further interpretation of possible additional material needs.

Bittium is undergoing regulatory approval processes for its medical devices in several different countries. As necessary, the company will apply for a new European medical device approval (MDR) for its medical technology products already in production, which are approved according to the current standard (MDD). Decisions on applying for MDR approvals for existing products will be made on a business basis or if significant changes are made to the products that require a new approval process.

Market Outlook

Medical ECG, EEG, and Sleep Apnea Remote Monitoring Market

The medical technology market is undergoing significant development in patient care, especially outside hospitals. There is an increasing focus on the prevention of diseases and health problems through early diagnosis and the discharge of patients at an earlier stage to reduce hospital and treatment days. These actions significantly increase efficiency in health care processes and lower costs.

A prerequisite for early hospital discharge is the enabling of accurate and precise follow-up and measurement opportunities in home conditions, which would be enabled through remote monitoring. Remote monitoring and remote diagnostics also enable specialists’ diagnoses regardless of time and place. Also, evolving artificial intelligence-based algorithms become more common in supporting physicians in making diagnoses. Remote monitoring and remote diagnostics make it possible and faster to obtain more accurate diagnoses, which, in turn, speeds up the start of the right kind of treatment. The market change will enable several new providers to join the overall care service chain, without compromising the quality of specialist services.

For measuring biosignals, as well as remote monitoring and diagnostics, Bittium provides its Bittium Faros™ product family for remote ECG monitoring, Bittium BrainStatus™ for measuring the electrical activity of the brain, home sleep apnea test solution Bittium Respiro™, and different kinds of diagnostics software offered by Bittium.

Regulation by the authorities has a strong role in bringing medical devices to the market. The requirements vary for different countries and the processes are long-term. Bittium has several regulatory approvals for its medical devices in progress in different countries. The company has achieved medical device approval of the new MDR standard level in the EU region for the Bittium Respiro™ product family that measures sleep apnea. Bittium has also applied for a medical device sales license for the Respiro product family from the US Food and Drug Administration (FDA). The schedule is affected by additional clinical studies determined by the FDA authority. The estimated duration of the additional work is at least one year.