Study Completed for FemDx Medsystems’ Mini Endoscopic System

FemDx Medsystems Inc. has completed its first-in-human clinical study of its miniaturized endoscopic system. The procedure was performed in February and yielded highly encouraging results, marking a significant milestone toward improving early detection and access to fallopian tubes under direct visualization, according to the company.

The device aims to visualize the fallopian tube lumen through the uterus. In the company’s initial study, clinicians performed patient cases with direct visual access to the tubal ostium and lumen. Physicians reported satisfaction with the product’s overall performance.

“This technology has the potential to revolutionize how we assess and access fallopian tubes for fertility evaluations and early detection of gynecologic pathology,” said Dr. Jose Garza, who led the study in Monterrey, Mexico.

FemDx Medsystems plans to continue clinical validation and expand its study cohort in preparation for regulatory submissions.

“The successful first-in-human study of the device marks a significant advancement in women’s health.” FemDx Medsystems Co-Founder/CEO Ashlee Francis stated. “Our team is dedicated to developing innovative solutions and this achievement brings us closer to providing clinicians with effective tools.”

FemDx Medsystems is a medical device company developing technologies that enhance women’s health. Its flagship product, FalloView, is the first falloposcope incorporating a CMOS chip endoscope, designed to provide direct visualization and access to the fallopian tubes. The device received U.S. Food and Drug Administration 510(k) clearance in March 2023.

FemDx Medsystems is funded by Palo Alto, Calif.-based ShangBay Capital, SV Tech Ventures, Portfolia Fund, WSGR, and well-known venture investors from Silicon Valley. ShangBay Capital is a medical technology-focused venture firm and Portfolia Fund is the world’s largest and most influential female investment community.