Tuesday, June 18, 2024

Medical Device Manufacturer Zeto Achieves FDA Clearance for Innovative Zeto ONE EEG System

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EEG system Zeto ONE has achieved 510(k) clearance from the Food and Drug Administration (FDA), as announced by U.S.-based medical device manufacturer Zeto. This innovative medical device is designed for use in various environments, including hospitals, homes, ambulances, and air transport settings.

The Zeto ONE medical device features a headset equipped with 21 soft-tip electrodes positioned according to the internationally recognized 10-20 EEG system, which standardizes electrode placement. This design ensures the system is user-friendly, requiring minimal training for operation. The headset also captures patient video and audio, and includes live AI-enabled seizure notifications, enhancing its functionality.

One of the standout features of the Zeto ONE medical device is its integration with the Zeto Cloud platform. This cloud-based system streams data in real-time, allowing neurologists to perform live remote interpretations. Additionally, the Zeto Cloud supports comprehensive EEG platform capabilities, including workflow management, patient scheduling, and report generation. EEG is a crucial medical test used to measure the brain’s electrical activity. It aids in diagnosing various conditions, such as epilepsy, sleep disorders, and brain tumors. The Zeto ONE system’s ability to deliver high-quality EEG data in diverse settings makes it a significant advancement in the field of neurology.

Medical Device Innovator Zeto Secures FDA Clearance for Versatile Zeto ONE EEG System

Founded in 2014 and based in Santa Clara, Zeto has been at the forefront of EEG technology innovation. In 2020, the company raised $7.3 million in Series A funding led by Seraph Group, with participation from Aphelion Capital, SV Tech Ventures, and Shangbay Capital. This funding has been instrumental in advancing Zeto’s technology and expanding its product offerings.

The FDA’s clearance of the Zeto ONE medical device follows the company’s earlier success with its first wireless, dry-electrode EEG headset, WR19, which was approved for clinical use in 2020. The WR19 underwent three clinical studies involving 50 subjects, demonstrating signal quality on par with FDA-cleared traditional EEG systems. These studies included simultaneous recordings with WR19 and Clinical EEG (cEEG) electrodes placed about 1cm-2cm apart, confirming the reliability and accuracy of Zeto’s technology.

The Zeto ONE system’s versatility extends beyond traditional hospital settings, making it suitable for home use and emergency situations in ambulances and air transport. This adaptability addresses the growing need for accessible and reliable neurological monitoring across different environments, providing a comprehensive solution for patient care. The integration of AI technology in the Zeto ONE medical device further enhances its utility. The AI-enabled seizure notifications provide immediate alerts, enabling timely intervention and improving patient outcomes. This feature, combined with the system’s remote interpretation capabilities, supports efficient and effective patient management.

Medical Device

Medical Device Leader Zeto Revolutionizes EEG Testing with FDA-Cleared Zeto ONE System

Zeto’s commitment to innovation and quality is evident in the development of the Zeto ONE medical device. By leveraging advanced technology and cloud-based solutions, the company is revolutionizing the way EEG data is captured, analyzed, and interpreted. This approach not only enhances the accuracy and reliability of EEG testing but also streamlines the workflow for healthcare providers, making it easier to deliver high-quality care to patients.

In addition to its technological advancements, Zeto places a strong emphasis on user experience. The Zeto ONE system’s design prioritizes ease of use, ensuring that healthcare providers can quickly and efficiently utilize the system without extensive training. This user-friendly approach is crucial in emergency and remote settings where time and resources are limited.

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The FDA clearance of the Zeto ONE system marks a significant milestone for Zeto, positioning the company as a leader in EEG technology. As the demand for advanced neurological monitoring continues to grow, Zeto’s innovative solutions are set to play a pivotal role in meeting this need. With its comprehensive features, real-time data streaming, and remote interpretation capabilities, the Zeto ONE system represents the future of EEG technology, offering a robust and versatile tool for healthcare providers worldwide.


Resource: PR Newswire, June 04, 2024

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