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CONTINUOUS AMBULATORY COUGH MEASUREMENT

SIVA is the first AI-based continuous ambulatory cough measurement system used in a global drug development study, providing cough profiles over several weeks.

WHO WE ARE

We are a Swiss medical device company in the field of voice biomarkers and collaborate with global healthcare companies, researchers and clinics.

Our patient-centric solution in the field of respiratory diseases is unique. It provides

  • Fully automated and real-time objective 24/7 cough profiles

  • High data consistency and data resolution

  • Important patient contextual data

  • A high level of proven convenience for patients and physicians

 

SIVA Cough Detector

The outstanding performance of the cough detection algorithm is based on a high-quality data pool and our machine learning capabilities.

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HOW IT WORKS

How It Works

The SIVA Wearable Device is used 24/7 by the patient. The patient wears it on the chest during daytime and keeps it by the bed side during nighttime. This enables continuous cough monitoring over several weeks.

Cough and patient contextual data are transferred to the study investigator or health professional on a daily basis.

OUR CAPABILITIES IN CLINICAL RESEARCH

At SIVA, we combine the relevant know-how and experience to effectively support pharmaceutical companies in the approval of drugs as well as researchers in answering unsolved questions: clinical and scientific affairs, regulatory affairs, quality management, hardware and software engineering and project management.​

Based on close collaboration with clinical drug development (original partner: Bayer), SIVA currently provides the 'SIVA-MVP research tool' with the following intended use:

The SIVA-MVP is intended for data collection in clinical studies to objectively measure cough of individuals. This data is collected to perform basic or applied clinical research, to establish registry data, or to generate evidence for a cough-reduction drug labeling claim. It is not intended for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease.

 

Note: This is not a medical device. Nothing herein should be construed as a solicitation or promotion of any product or of an indication of any specific use for any product.

SIVA Cough Detector
SIVA Cough Detector & Charger

SIVA Health AG is certified according to EN ISO 13485:2016.

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The final external audit for the European Medical Device Regulation

(EU MDR) along with the 2nd surveillance audit for ISO 13485 was completed. Medical device approval of the full system in the European market is expected soon.

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MOST RECENT STUDIES

Clinical Validation Study NCT04861155 at the University Hospital Zurich, Switzerland. 
The published results show excellent performance of the cough detection algorithm and very high user acceptance.

Clinical Validation Study NCT05689307 at the Bellingham Asthma, Allergy & Immunology Clinic in the U.S.

For more information, please contact us via 

info@siva-health.com

OUR LEGACY AND INDUSTRY COMMITMENT

The SIVA system was originally developed in close cooperation with drug development in the pharmaceutical industry (Bayer). In July 2023, SIVA Health AG became fully independent and owns all generated IP.

The system is now used in global drug development studies as well as usability studies and scientific studies around the world.

Our partners in the pharmaceutical industry and in research value our expertise and commitment in the field of continuous ambulatory cough measurement. We are happy to provide references.

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