It’s Happening! The Clinical Trial is in March!
I have spoken in previous blogs about why EMF Disturbance Monitors, Inc. needs FDA approval to begin sales in the U.S. I’ve also gone over the rationale for needing clinical trials for new forms of medical devices. (You can read those blogs in the list below). After discussions with the FDA staff, EMF Disturbance Monitors, Inc. will be applying for approval as a Class II medical device in the De Novo medical device category. This means there are no similar medical devices which the FDA has reviewed and approved. Our medical device will be a “first of its kind”. As such, we will need to provide the FDA with information about how our technology works and the safety of our technology.
In March, 2024, EMF Disturbance Monitors, Inc. will collaborate with The University of North Carolina at Chapel Hill for both a pre-clinical trial and an animal safety trial of our new technology. The pre-clinical trial will focus on calibrating our equipment prototypes and establishing the optimal conditions for our animal trial. This means the equipment will be shipped to UNC, assembled and tested without animal patients. To complete our pre-clinical trial, we will run tests on “Reece”, our stuffed animal which resembles a Rhesus monkey. This pre-clinical data will be important to create a safe environment for our animal trial.
Our animal safety trial is designed to demonstrate that we can detect electromagnetic energy emissions from the heart of a Rhesus monkey. Rhesus monkeys are much smaller than humans. They are about the size of a large house cat. Although their hearts are small (about the size of a ping pong ball), Rhesus monkeys share 98% of our human DNA. Their hearts are built like ours, and function in the same way. During the trial, the Rhesus monkeys will wear a little cloth vest with sensors while we determine the best testing environment for detecting electromagnetic energy emissions from their hearts. After the test, they will return to their enclosures with their group.
The information we will collect from the pre-clinical trial and the animal safety trial will be extremely important and valuable. Because we are a “De Novo” medical device, any information from these tests will be important to share with the medical community and the FDA. We are in the process of creating our cloud data storage environment, where all our our trial data will be available for analysis and reporting. Cloud data storage and information sharing will be critical to our role as a medical device for diagnosis of congestive heart failure. It will also permit machine learning and artificial intelligence to constantly update the algorithms needed for an accurate diagnosis of heart disease. I will be sharing photos of our trials on our Web page over the next 2 months. I have to admit that I’m a little nervous but also really excited! Follow along with our journey at emfdisturbancemonitors.com
