GBT Tokenize Engaged M Squared Associates to Support FDA 510(k) Submission for qTerm

January 28, 2021 6:00 AM EST

Get inside Wall Street with StreetInsider Premium. Claim your 1-week free trial here.

SAN DIEGO, Jan. 28, 2021 (GLOBE NEWSWIRE) -- GBT Technologies Inc. (OTC PINK: GTCH) ("GBT”, or the “Company”) announced today that GBT Tokenize Corp (“GBT/Tokenize”) engaged M Squared Associates (M2) to assist with developing the FDA premarket strategy for its qTerm device. For more than 20 years, M2 has been providing a full range of regulatory, quality and clinical consulting services to US and international medical technology firms. M2 specializes in devices, biologics and combination products that are reviewed by FDA's Center for Devices and Radiological Health (CDRH).

The process of filing for FDA clearance involves development of a sound regulatory strategy for pathway to market, including required preclinical and performance testing, software verification and validation activities and ensuring user needs are met. In addition, GBT/tokenize will partner with M2 to finalize technical design documentation, device labeling claims and intended use. Other aspects that will be evaluated include manufacturing processes, usability / human factors and the development of valid scientific evidence. The company will work with M2 to develop a detailed description of the device’s software and algorithm training requirements, including design specifications. qTerm computer program will be reviewed for its control functions and other required performance testing plans and criteria according to FDA guidance documentation.

qTerm is a human vitals device that 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”). qTerm device is designed to work with a smartphone app and web application that will keep a history for the user's records, provide a geographical proximity alert and record statistical data about the user's vitals. The device will be empowered by an AI system for data analytics, proximity alerts and personal health management. qTerm will also be evaluated to work within remote telemedicine infrastructure and therefore an extra attention will be done for its cybersecurity system.

"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.

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.

Contact: Dr. Danny Rittman, CTO press@gopherprotocol.com

Primary Logo

Source: GBT Technologies Inc.


Serious News for Serious Traders! Try StreetInsider.com Premium Free!

You May Also Be Interested In





Related Categories

Globe Newswire, Press Releases

Related Entities

FDA