FemDx Medsystems has completed the first-in-human clinical study of its fallopian tube visualization technology with positive results, the women’s health medical device company announced today.
The study, conducted in February 2025 in Monterrey, Mexico, tested a miniaturized endoscopic system designed to provide direct visual access to the fallopian tube lumen through the uterine route. According to the company, the procedures successfully demonstrated visualization of the tubal ostium and lumen.
“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 clinical study in Mexico.
The company’s device, called FalloView, is described as the first falloposcope to incorporate a CMOS chip endoscope specifically for fallopian tube examination. FalloView has already received FDA 510(k) clearance.
“The successful first-in-human study of the device marks a significant advancement in women’s health,” said Ashlee Francis, CEO and Co-founder of FemDx Medsystems. “Our team is dedicated to developing innovative solutions and this achievement brings us closer to providing clinicians with effective tools.”
Direct visualization of fallopian tubes could potentially improve diagnostic capabilities for conditions affecting female fertility and reproductive health. Currently, many fallopian tube assessments rely on indirect imaging methods or more invasive surgical procedures.
Following these initial results, the company plans to continue clinical validation studies and expand its patient cohort in preparation for regulatory submissions to support a commercial launch.
FemDx Medsystems is backed by several investors including ShangBay Capital, a medical technology-focused venture firm based in Palo Alto; SV Tech Ventures; Portfolia; WSGR; and other Silicon Valley venture investors.
