Cycle Clarity Receives FDA 510(k) Clearance for Follicle Clarity

Cycle Clarity’s artificial intelligence software, Follicle Clarity, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Follicle Clarity is a software application package that is designed to view and quantify image data acquired on compatible ultrasound systems. Follicle Clarity is used as an aid to interpreting clinicians by calculating the number and sizes of hypoechoic structures in a transvaginal ultrasound volume sweep.

Infertility is a common disorder affecting approximately 14% of American couples which is approximately 28 million couples every year in America.  In developing countries 25% of couples have infertility with an estimated 186 million couples having infertility. The field of Reproductive Endocrinology has as a primary goal of helping couples with infertility complete their reproductive goals. Follicle Clarity’s mission is to help achieve this goal as well. 

There are many benefits to using MyCycleClarity. One advantage of MyCycleClarity is the standardization of measurements between ultrasonographers and across the fertility network. The second advantage is a significant decrease in ultrasound time when using MyCycleClarity, versus manual human measurement techniques. This ultimately provides the patient with a much more comfortable experience during monitoring ultrasounds of any stimulation fertility treatment.

Follicle Clarity is officially commercially available and has been validated for use with the following 3D ultrasound systems: GE Voluson Systems, Siemens Acuson Systems, Philips Epiq Systems, and Mindray Ultrasound Systems.