First-in-human study of fallopian endoscopic system has positive results

FemDx Medsystems has announced the successful completion of its first-in-human clinical study of its miniaturised endoscopic system designed to visualise the fallopian tube lumen via the uterine route.

In this initial study, patient cases were performed with direct visual access to the tubal ostium and lumen. Physicians reported satisfaction with overall performance.

The procedure was performed in February 2025 and yielded highly encouraging results, according to the company, marking a significant milestone toward improving early detection and access to fallopian tubes under direct visualisation.

The device, called FalloView, is the first falloposcope incorporating a CMOS chip endoscope, designed to provide direct visualisation and access to the fallopian tubes. The device has received FDA 510(k) clearance.

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

“The successful first-in-human study of the device marks a significant advancement in women’s health.” Ashlee Francis, CEO and Co-founder of FemDx Medsystems, commented on the milestone.

“Our team is dedicated to developing innovative solutions and this achievement brings us closer to providing clinicians with effective tools.”

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