The Food and Drug Administration will use this new department to regulate equipment that indicates oxigen saturation, sugar level in the blood, ECG and other heart monitors and future health measurers and data loggers. Devices are grouped in three categories:
Class 1 : not used to sustain life and cause little danger.
Class 2 : a sensor goes through the skin or other prolonged contact with the patient.
Class 3 : implanted in the body or otherwise depended upon to sustain life.
NEW TESTING APPARATUS
Theranos
Elizabeth Holmes had an idea to develop medical tests using a small drop of blood and an electronic chip. Her mantra becomes "lab on a chip". Her device is analysed by the Defence Deparment, which does not validate the device. In 2013, Walgreen pharmacies offer Theranos blood tests in its facilities. On 23 may 2013, Theranos' chief scientist commits suicide. Meanwhile, conventional tests are being performed even though the company was claiming to use brand new technology. In february 2015, professor John Iaonnidis from Stanford university writes in JAMA (journal of the american medical association) that there is nothing in the scientific literature validating the new technology. Professor Diamandis from the university of Toronto decribes the claims as wildly egagerated. Vice president Joe Biden tours the facility, which was expanded and modified for the visit ! He is positively impressed ! In october 2015, John Carreyrou, from the Wall Street Journal, exposes the fraud : conventional tests are being performed, the Edison device is not being used and the "nanotainer" does not exist. In November 2015, the Arizona Republic discloses that all of Theranos is a fraud. In 2016 and 2017, government investigations and layoffs occur. In 2018, criminal charges are laid. On january 3, 2022, Elizabeth Holmes is found guilty of fraud. The story is told in TV documentaries and movies.
Blood sugar level monitoring
Levels Health offer mobile units to measure glucose. Expect to pay $400 per month
Digbi Health
They claim that their analysis of stools indicates the state of the microbiote, which is involved in some illlnesses.
Skin and Me
Pictures of the skin is analysed by doctors
Teva
This device is not a consumer product.
Apple
Future watches could interpret ECG, etc.
Lumen
This tube through which one takes a deep breath supposedly determines whether one burns fat or glucides. This is a falacy! We all burn glucose and low carb-high fat regimens are dangerous! Dieting should be a long-term family-wide endeavor.
New electronic devices provide centralised data, better analysis of chronic conditions, continuous monitoring, faster data transfer and better clinical outcome.
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