San Rafael, California – CrossBay Medical Inc. officials announced the United States Food and Drug Administration (FDA) clearance of its product, the SonoSure Sonohysterography and Endometrial sampling device. The device has also received Health Canada clearance and the CE mark. The SonoSure is indicated for use to access the uterine cavity for saline infusion sonohysterography (SIS) and to obtain endometrial biopsy (EMB), if indicated, utilizing the same device.
Abnormal uterine bleeding (AUB) occurs in 20% of women between the ages of 19 to 55. SIS and EMB are routinely used in the workup for AUB. Many providers perform these procedures at the same setting, using separate instrumentation for each procedure. This requires cannulation of the cervix at least twice. Other providers may require patients to have separate visits for the procedures. The SonoSure device combines SIS and EMB in the same device.
"We are excited about receiving the clearance for SonoSure as we can now provide our affiliate partners in the US, Canada and Europe with a truly affordable and effective product," said Piush Vidyarthi, CEO of CrossBay Medical Inc. "CrossBay's goal is to continue to develop innovative devices for women and children for the global market. We have numerous products in development that we plan to bring to market in the near future."
In the U.S., CrossBay has entered into an exclusive agreement to commercialize the product.
"At Norgenix, it is our goal to offer quality products that provide solutions to the unmet needs within women's health," stated Michael Rackley, COO & senior vice president of Norgenix. "We immediately recognized the value that CrossBay Medical's devices may have for gynecology. With the exclusive rights to market, sell, and distribute the SonoSure in the U.S., we look forward to providing such innovations to the healthcare marketplace."
Source: Crossbay Medical Inc.