$GTCH (GLOBE NEWSWIRE) big news out: 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 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.