GBT Technologies Inc. ( OTCMKTS: GTCH ) announced on January 12th, 2021, they are seeking approval from the United States Food and Drug Administration so their qTerm device can meet the high standards of consumers in the market.
The qTerm is a human vitals’ device powered by AI. The intention is to measure human vitals with a touch of a finger. The qTerm device measures body temperature, blood oxygen level and heart rate. The next phase looks add a blood pressure feature. qTerm will have a smartphone app and web application which will keep the history of user records.
GBT Technologies Inc. ( OTCMKTS: GTCH ) FDA Approval
The FDA requires approval for devices that perform functions which assist with diagnosis and health monitoring. This is important to prove functionality, safety, and biocompatibility. qTerm will be filed under PART 880, (GENERAL HOSPITAL AND PERSONAL USE DEVICES), and Subpart C, (General Hospital and Personal Use Monitoring Devices). qTerm is best described as an electronic device used to measure body vitals of a patient by way of a transducer joined with an amplified electronic signal, conditioning, and display unit. The classification is in Class I or II and the FDA approval will grant qTerm formal approval so it can used and sold as a medical device. This certification is vital to ensure safety, accuracy, and effectiveness for public use.
CTO Danny Rittman of GBT Technologies Inc. ( OTCMKTS: GTCH ) stated,
they are seeking FDA approval to confirm their device meets high standards and compliance. The goal is to gain customer confidence and trust. They plan to meet this goal by confirming the performance and accuracy of the qTerm device. The plan is to offer their technology for personal, hospital, and clinical use. To be marketed and sold in the U.S. as safe and effective, qTerm needs FDA approval. Mr. Rittman explained that the AI technology in qTerm is the main advantage when compared to competitor devices. It is their Artificial Intelligence technology. This technology advances the devices features. GBT Technologies Inc. ( OTCMKTS: GTCH ) understands applying for FDA clearance is a long process but it will bring their technology to the highest standards.