Sam Brusco, Associate Editor03.27.23
FemDx Medsystems, a women’s health startup, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its FalloView device.
According to the company, the device is the first totally disposable 1.2 mm diameter falloposcope incorporating a CMOS chip endoscope to evaluate the proximal fallopian tube in a non-invasive way.
FalloView has a self-contained light source and video monitor powered by a 9-volt battery—the gynecologist is then given untethered access to the uterus and fallopian tubes without remote video imaging and weight of an attached camera cable and light cord. An LCD screen on FalloView’s handle lets the physician visualize internal patient anatomy in line with instrument insertion.
Albert K. Chin, M.D., chief innovation officer of FemDx Medsystems stated 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 is developing further devices to address additional critical women’s health issues—for example, improved instrumentation to facilitate uterine fibroid ablation and resection.
According to the company, the device is the first totally disposable 1.2 mm diameter falloposcope incorporating a CMOS chip endoscope to evaluate the proximal fallopian tube in a non-invasive way.
FalloView has a self-contained light source and video monitor powered by a 9-volt battery—the gynecologist is then given untethered access to the uterus and fallopian tubes without remote video imaging and weight of an attached camera cable and light cord. An LCD screen on FalloView’s handle lets the physician visualize internal patient anatomy in line with instrument insertion.
Albert K. Chin, M.D., chief innovation officer of FemDx Medsystems stated 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 is developing further devices to address additional critical women’s health issues—for example, improved instrumentation to facilitate uterine fibroid ablation and resection.