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GBT Seeks FDA Approval for its qTerm Device

Tuesday, January 12, 2021

GBT Technologies Inc. announced that GBT Tokenize Corp (“GBT/Tokenize”) it is seeking approval filing for its qTerm device with the United States Food and Drug Administration (“FDA”).

The qTerm, a human vitals device powered by AI, is aimed to measure human vitals with a touch of a finger. The device received its Trademark allowance notice and will present it on the product/package as required by the United States Patent Office (“USPTO”). In its first release, the qTerm device is targeted to measure body temperature, blood oxygen level and heart rate. In the next release, GBT/Tokenize plans to add a blood pressure feature. qTerm device will be accompanied by a smartphone app and web application that will keep a history for the user's records, providing a geographical proximity alert and record statistical data about the user's vitals.

Electronic medical devices that perform complex functions to assist with diagnosis, and monitoring health conditions require an FDA approval. It is important to demonstrate the device's functionality, safety, and biocompatibility. The FDA classifies medical devices from Class 1 – 3, each of which must be subjected to robust evaluations and reviews to comply with manufacturing quality control (QC) standards. The FDA regulates the marketing/sale of medical device products in the U.S. and monitors the safety of all regulated medical products. FDA Section 201(h) of the Food, Drug & Cosmetic Act (FD&C Act) defines a device as: an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or intended to affect the structure or any function of the body of man or other animals. (*)

It is intended that the device will be filed under PART 880 -- GENERAL HOSPITAL AND PERSONAL USE DEVICES, Subpart C - General Hospital and Personal Use Monitoring Devices as a clinical electronic device that is used to measure body vital of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The device's classification is estimated to be Class I/II and it is expected that it will be determined by the FDA further review. FDA approval means formal approval as a medical device to be marketed and sold in the U.S. This type of certification is essential to ensure the device's safety, accuracy, and effectiveness for public use.

"We seek to have our qTerm human vitals device approved by the FDA to confirm high standards and compliance. Another aspect is to gain potential customer's confidence and trust in the product's performance and accuracy. We plan to offer the technology for personal, hospitals and clinics usage and seeking to comply with the industry's standards and regulations. FDA approval means that the FDA has formally approved the qTerm product to be safe and effective for market and sale in the U.S. Our qTerm device is an external, non-invasive device that is targeted to measure human vitals. In addition, we believe that its main advantage upon similar products is its Artificial Intelligence technology that offers advanced features like real-time health statistics, analytics, and monitoring. The device is designed to assist in potential illness prevention by providing a real time, geographically proximity alert. It is easy for use, and mainly intuitive. We believe that this type of device can become a personal health assistant monitoring, analyzing, and alerting for potential issues in real time. Early detection of potential health issues, based on vitals can be crucial and a life saver. Applying for an FDA clearance is a long process but we strongly believe it will bring our technology to the highest standards to be used by hospitals and individuals," said Danny Rittman, CTO of GBT Technologies.

* Source: FDA - How to Determine if Your Product is a Medical Device | FDA

About Us
GBT Technologies, Inc. (OTC PINK: GTCH) (“GBT”) (http://gbtti.com) is a development stage company which considers itself a native of Internet of Things (IoT), Artificial Intelligence (AI) and Enabled Mobile Technology Platforms used to increase IC performance. GBT has assembled a team with extensive technology expertise and is building an intellectual property portfolio consisting of many patents. GBT’s mission, to license the technology and IP to synergetic partners in the areas of hardware and software. Once commercialized, it is GBT’s goal to have a suite of products including smart microchips, AI, encryption, Blockchain, IC design, mobile security applications, database management protocols, with tracking and supporting cloud software (without the need for GPS). GBT envisions this system as a creation of a global mesh network using advanced nodes and super performing new generation IC technology. The core of the system will be its advanced microchip technology; technology that can be installed in any mobile or fixed device worldwide. GBT’s vision is to produce this system as a low cost, secure, private-mesh-network between any and all enabled devices. Thus, providing shared processing, advanced mobile database management and sharing while using these enhanced mobile features as an alternative to traditional carrier services.

Forward-Looking Statements
Certain statements contained in this press release may constitute "forward-looking statements". Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website ( http://www.sec.gov). In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, governmental and public policy changes, the Company’s ability to raise capital on acceptable terms, if at all, the Company’s successful development of its products and the integration into its existing products and the commercial acceptance of the Company’s products. The forward-looking statements included in this press release represent the Company's views as of the date of this press release and these views could change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of the press release.

Dr. Danny Rittman, CTO
press@gopherprotocol.com

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