This is a great way to start the year! We started working with Dr. John Schnorr who is a renowned fertility specialist in Charleston, South Carolina in early 2019.
He had a brilliant idea but needed an ultrasound machine that would do what he needed it to do. So in the process of seeking FDA approval he had to test several ultrasound machines to prove the accuracy of his creation.
We tried many manufacturers but nothing seemed to be a perfect fit. Dr. Schnorr approached Ultra Select Medical because he had purchased machines from them prior to 2019. Ultra Select Medical has experience in ultrasound research and applications which is an added benefit for Dr. Schnorr for this project.
During the process of bringing a breakthrough technology to bear requires hours of testing on many levels. The entire process can be slowed by one single issue. One such question was whether this algorithm could run on 2D, 3D or 4D ultrasound. Could this software use two types of ultrasound? This had to be proven or disproven. What had to be done in the Ultra Select Medical lab was to test the accuracy of simple measurements in all three types of ultrasound. A protocol was developed and it was quickly proven that the best accuracy and reproducibility could only be achieved in 3D ultrasound. Testing this one issue took a week of doing nothing but running measurements with an ultrasound machine with 3D and 4D capabilities.
Mindray North America entered the process because the 3D cine sweeps had to be done in a specific way. Mindray worked with Ultra Select Medical and Dr. Schnorr to provide a great product that would work well with Cycle Clarity. On January 21, 2022 the FDA approved Cycle Clarity software and shortly thereafter the approved revisions from Mindray came through.
What does all this mean? This will be a huge breakthrough for diagnosis in the fertility market. By drastically shortening the scanning time it will benefit both the patients and the providers. What took a sonographer or doctor a half hour will now take about five minutes. If you were the patient you could appreciate being spared the discomfort for that period of time. Think about the patients who are waiting anxiously for their results and now those results are ready in seconds.
Ultra Select Medical and Cycle Clarity are fast growing companies who will rise to the top of their respective fields. Mindray North America will also have significant gains because they have provided a customized DC70 for the fertility market. These new units will only be available at Ultra Select Medical. This is a win- win –win for all three businesses.
For any questions or to discuss research using ultrasound please call 843-566-1020.