$GTCH "We would like to bring our qTerm device to

$GTCH "We would like to bring our qTerm device to the highest standards within this domain and FDA clearance will demonstrate that the device is safe and effective for its intended use and confirm compliance with regulations and guidelines. Our objectives are to assure qTerm’s credibility as part of our plans for national commercialization. The technology is intended for personal and clinical use and will also be evaluated for remote telemedicine operation. Therefore, an extra focus will be on its cybersecurity system and protocol. FDA review process will include evaluation of hardware and software systems, including functional verification and validation testing performance data. A comprehensive assessment of risks, data analysis, and cybersecurity requirements will be conducted. In addition, a thorough review of its development environment, revision history, and unresolved anomalies will be done according to FDA guidelines. qTerm device is a non-invasive device to measure human vitals and includes an intelligent analytics system. The FDA submission process is involved, with complex regulatory challenges that are typically associated with advanced technologies and therefore we decided to hire experts in the field.” Stated Danny Rittman, the Company’s CTO.

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