FemDx Receives FDA Clearance for Its FalloView Falloposcope
The device is the first totally disposable 1.2mm diameter falloposcope incorporating a CMOS chip endoscope.
FemDx Medsystems, 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.
In addition, Albert K. Chin, M.D., Chief Innovation Officer of FemDx Medsystems, Inc. states that the company’s first patent, associated with the method of use of the device, has been issued by the U.S. Patent and Trademark Office last week. Multiple patent applications have been filed on additional designs and devices. Albert K. Chin is the author of 227 issued U.S. patents.
Pei-Jie Cao, Ph.D., CTO of FemDx Medsystems, Inc. is developing subsequent devices to address additional critical issues in women’s health; for example, improved instrumentation to facilitate uterine fibroid ablation and resection. The collective development of novel diagnostic and therapeutic instrumentation will positively advance underserved segments in women’s health initiatives.
FemDx Medsystems, Inc. is funded by ShangBay Capital, SV Tech Ventures, and well-known venture investors from Silicon Valley. ShangBay Capital is a leading medical technology-focused venture firm based in Palo Alto, California. The fund has invested in 62 companies and has had multiple successful exits to date.
