CardiacSense Ltd

CardiacSense Ltd is a private Israeli medical-device and digital-health company headquartered in Caesarea. Founded in 2009 under the name Sportracker, the business initially developed technology for tracking heart-rate readings during sports activities. In 2015, it changed its name to CardiacSense and redirected its focus toward regulated medical monitoring. The company’s principal offering is a wrist-worn medical device designed for continuous, rather than occasional, measurement of cardiac and other physiological parameters. Its technology combines electrocardiography (ECG), photoplethysmography (PPG), optical sensing, mechanical design, and signal-processing algorithms. The company states that its proprietary optical and artifact-sensing approach is intended to reduce the effects of movement that can compromise PPG measurements. CardiacSense devices are designed to monitor heart rate and heart-rate variability and to identify a range of cardiac events and conditions, including atrial fibrillation, tachycardia, bradycardia, premature ventricular contractions, premature atrial contractions, pauses, and cardiac arrest. The broader vital-sign platform also covers continuous cuffless blood-pressure measurement, respiratory rate, oxygen saturation, body temperature, and skin temperature. The company has described further applications in monitoring sleep apnea, chronic obstructive pulmonary disease, and deterioration associated with congestive heart failure. When an arrhythmia or other configured event is detected, the device can alert the wearer and transmit information to a physician. Data are stored in the watch and uploaded to a cloud application through the user’s cellular device. The company has described a prescription-based model for the United States, where clinicians can determine whether and when notifications should be sent, while stating that a prescription would not be required in Europe and other markets, subject to local regulatory and commercial conditions. CardiacSense began clinical evaluation at Tel Aviv Sourasky Medical Center, completing its first clinical trial in 2016. Subsequent multisite clinical work involved Israeli medical centers including Rambam Health Care Campus and Sheba Medical Center, as well as the University of California, San Francisco. The company has also indicated plans for additional clinical studies concerning respiratory rate, sleep apnea, oxygen saturation, and blood pressure. Its CSF-3 watch received United States Food and Drug Administration clearance for ECG, beat-by-beat heart rate, and arterial-hemoglobin oxygen saturation measurement. In Europe, the watch received CE approval under the Medical Device Regulation for four indications, including continuous atrial-fibrillation monitoring and beat-by-beat pulse-rate measurement using PPG. Following the European regulatory approval, CardiacSense stated that it had begun commercialization in a group of countries across Europe, Asia, and South America and was preparing additional United States submissions and commercial partnerships. CardiacSense is positioned in the remote-patient-monitoring and wearable medical-device segment rather than the general fitness-tracker market. Its differentiation is based on continuous monitoring, medical certification, multi-parameter sensing, and the intended connection between wearable measurements, cloud data, and clinical decision-making. The company remains privately held, and publicly available reference material does not establish a current executive roster, a definitive commercial partner, or a final United States launch outcome.

CardiacSense began in 2009 as Sportracker, a company oriented toward sports-related heart-rate tracking. Its original activity was associated with measuring heart-rate readings during athletic use. In 2015, the company adopted the CardiacSense name and shifted its strategy toward medical devices and continuous physiological monitoring. The new direction centered on a wrist-worn system combining ECG and PPG sensors. CardiacSense developed optical, mechanical, and algorithmic methods intended to improve the reliability of PPG readings during movement, an important issue for wearable monitoring. The company’s platform was designed to move beyond simple pulse tracking by identifying clinically relevant rhythm disturbances and by collecting several additional vital signs. CardiacSense completed its first clinical trial at Tel Aviv Sourasky Medical Center in 2016. Later clinical programs were conducted across multiple institutions, including Tel Aviv Sourasky Medical Center, Rambam Health Care Campus in Haifa, Sheba Medical Center in Ramat Gan, and UCSF. These studies supported the company’s efforts to validate cardiac monitoring and to expand the system’s potential applications to respiratory rate, sleep apnea, oxygen saturation, and blood pressure. The company’s monitoring concept links the wrist device to a cloud application through the user’s cellular device. Measurements can remain in the watch’s memory and later be uploaded, while detected arrhythmias can generate alerts for the wearer and messages for a physician. The proposed United States model uses prescription access and allows the physician to determine notification settings; the company has described a non-prescription model for Europe and other regions, subject to applicable requirements. A significant regulatory milestone was the reported FDA clearance of the CSF-3 watch for ECG, beat-by-beat heart-rate, and arterial-hemoglobin oxygen-saturation measurement. CardiacSense also reported CE approval under the European Medical Device Regulation for four indications, including continuous atrial-fibrillation monitoring and beat-by-beat pulse-rate measurement using PPG. These approvals supported the company’s move from development toward commercialization in selected international markets. The company reported that the medical-grade CSF-3 watch had entered commercialization in a dozen countries across Europe, Asia, and South America. It also described plans to submit additional United States data for further indications and to pursue American commercial partnerships. The available reference material does not confirm the final status of those planned submissions, partnerships, or a United States market launch. CardiacSense’s historical development therefore follows a transition from sports tracking to regulated digital health. Its current identity is based on continuous cardiac-rhythm surveillance, multi-parameter vital-sign measurement, clinical validation, and remote data sharing. It remains a private company, and no reliable public executive roster or parent-company relationship is established in the supplied references.

• 2016

  First clinical trial completed

  [1]CardiacSense Ltden.wikipedia.org

  CardiacSense completed its first clinical trial at Tel Aviv Sourasky Medical Center.

• 2015

  Rebrand and medical-device refocus

  [1]CardiacSense Ltden.wikipedia.org

  Sportracker changed its name to CardiacSense and redirected its activities toward medical devices and continuous cardiac monitoring.

• 2009

  Company founded as Sportracker

  [1]CardiacSense Ltden.wikipedia.org

  The business was established under the name Sportracker with an initial focus on tracking heart-rate readings during sports activities.

• FDA clearance for core CSF-3 measurements

  [1]CardiacSense Ltden.wikipedia.org

  The company reported FDA clearance for ECG, beat-by-beat heart rate, and arterial-hemoglobin oxygen saturation measurement by the CSF-3 watch.

• European MDR approval and international commercialization

  [1]CardiacSense Ltden.wikipedia.org

  The CSF-3 watch received CE approval under the European Medical Device Regulation for four indications, after which CardiacSense reported commercialization in selected countries across Europe, Asia, and South America.

A regulated wearable-medical-device company focused on continuous, cloud-connected monitoring of cardiac rhythms and multiple vital signs for clinical and remote-patient-monitoring use.

• Medical monitoring smartwatch

  CSF-3

  The CSF-3 is CardiacSense’s wrist-worn medical monitoring device. It combines ECG and PPG sensing with proprietary mechanical, optical, and algorithmic features intended to support continuous measurement and reduce motion-related artifacts. Reported capabilities include ECG, beat-by-beat heart rate, heart-rate variability, arrhythmia detection, oxygen saturation, respiratory rate, cuffless blood pressure, body temperature, and skin temperature. The device is designed to identify events such as atrial fibrillation, tachycardia, bradycardia, premature beats, pauses, and cardiac arrest, with data transmission to a cloud application and configurable clinical alerts.

• 2015

  Shift from sports tracking to medical monitoringStrategy

  Background

  The company’s original Sportracker business focused on heart-rate tracking during sports, while the renamed CardiacSense business pursued regulated medical-device applications.

  Action taken

  The company changed its name to CardiacSense and refocused product development on continuous cardiac and vital-sign monitoring.

  Aftermath

  The repositioning led to clinical trials, regulatory submissions, and development of the CSF-3 medical monitoring watch.

  Source

• Regulated-market rollout of the CSF-3 watchProduct launch

  Background

  After receiving reported European and United States regulatory clearances for specified measurements and indications, CardiacSense moved toward commercial distribution.

  Action taken

  The company reported beginning commercialization in selected countries across Europe, Asia, and South America and preparing additional United States regulatory submissions.

  Aftermath

  The available reference does not establish the final outcome of the planned additional submissions, United States partnerships, or United States launch.

  Source

1. 1CardiacSense Ltden.wikipedia.org