GBT
Seeks FDA
Approval for its
qTerm Device
San Diego, CA
-- January 12, 2021 -- InvestorsHub NewsWire
-- GBT Technologies Inc.
(OTC
PINK: 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").
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