[caption id="attachment_91389" align="alignnone" width="513"] CrossBay Medical's SonoSure tool for evaluating abnormal uterine bleeding was approved by the U.S. Food and Drug Administration.[/caption]
SAN RAFAEL -- CrossBay Medical, Inc., maker of clinical products for children and women, on Friday said it received U.S. Food and Drug Administration clearance of its SonoSure device for diagnosing a chronic gynecological condition said to affect one-fifth of young to middle-aged U.S. women.
The sonohysterography and endometrial sampling device also received Health Canada clearance and the CE mark for Europe, according to CrossBay, which was founded in 2009.
"We are excited about receiving the clearance for SonoSure, as we can now provide our affiliate partners in the U.S., Canada and Europe with a truly affordable and effective product," said Piush Vidyarthi, co-founder and chief executive officer, in a statement. "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."
The SonoSure device treats abnormal uterine bleeding, which CrossBay said occurs in 20 percent of women ages 19--55. Saline infusion sonohysterography and endometrial biopsy are routinely used in the workup for the bleeding.
Many providers perform these procedures at the same setting, using separate instruments for each procedure, the company said. This requires cervix cannulation, or insertion of a tube, at least twice. Other providers may require patients to have separate visits for the procedures.
CrossBay in late March announced it had entered into an exclusive agreement with Norgenix Pharmaceuticals, LLC, to commercialize SonoSure and the children-oriented products in the U.S..
"At Norgenix, it is our goal to offer quality products that provide solutions to the unmet needs within women's health," said Michael Rackley, chief operating officer and senior vice president of Norgenix. "We immediately recognized the value that CrossBay Medical's devices may have for gynecology."
The children's line of CrossBay Medical (crossbaymedicalinc.com) products includes GentleHeel for taking blood samples from newborns, BioMattress covers for infant intensive care beds that withstand more cleanings before replacement, IDLink identification system for newborns in such hospital units and NuBag collection sacks for diagnosing urinary tract infections.