#AI #Health #Stock News: GBT (OTCPINK: $GTCH) Seeks FDA Approval for its qTerm Device; #Artificialintelligence
San
Diego, CA, January 12, 2021 – (Investorideas.com Newswire) GBT Technologies Inc. (OTCPINK: GTCH) ("GBT”, or the “Company”)
announced that GBT Tokenize Corp (“GBT/Tokenize”) it is seeking approval filing
for its qTerm device with the United Stated Food and Drug Administration
(“FDA”).
Read this news, featuring
GTCH in full at https://www.investorideas.com/CO/GOPH/news/2021/01121Seeks-FDA-Approval-qTerm-Device.asp
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 State
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 US. 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 US. 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."
* 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.
Contact:
Dr.
Danny Rittman, CTO
press@gopherprotocol.com
GBT Technologies
Inc. (OTCQB:GTCH) is a featured tech stock on
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