#AI #Health #Stock News: GBT Tokenize
(OTCPINK: $GTCH) Engaged M Squared Associates to Support #FDA 510(k) Submission
for qTerm; #Artificialintelligence
SAN DIEGO - January 28, 2021 (Investorideas.com Newswire) GBT Technologies Inc. (OTCPINK: 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).
Read this news
featuring GTCH in full at https://www.investorideas.com/CO/GOPH/news/2021/01281M-Squared-Associates.asp
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
GBT Technologies Inc.
(OTCQB:GTCH) is a featured tech stock on
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