Articles from FemDx Medsystems, Inc.

FemDx Medsystems, a pioneering medical device company focused on advancing gynecological diagnostics, is proud to announce the successful completion of its first-in-human clinical study. The procedure was performed in February 2025 and yielded highly encouraging results, marking a significant milestone toward improving early detection and access to fallopian tubes under direct visualization.

FemDx Medsystems, Inc., a women’s health startup based in Santa Clara, CA announces the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its FalloView™ device. According to Ashlee Francis, CEO of FemDx Medsystems, Inc., the device is the first totally disposable 1.2mm diameter falloposcope incorporating a CMOS chip endoscope to evaluate the proximal fallopian tube in a non-invasive fashion. The FalloView™ falloposcope has a self-contained light source and video monitor powered by a 9 volt battery, providing the gynecologist with untethered access to the patient’s uterus and fallopian tubes without the traditional constraints of remote video imaging and the weight of attached camera cable and light cord associated with conventional instrumentation. The LCD screen on the handle of the device allows the physician to visualize internal patient anatomy in line with instrument insertion.