It’s estimated that approximately 76 percent of procedures used to visualize the uterus and identify the cause of abnormal bleeding – known as hysteroscopy – are performed in a hospital’s operating room. However, diagnosis and commencement of treatment could be faster for patients if these hysteroscopy procedures could be done in a doctor’s office.
Now, the US Food and Drug Administration (FDA) has approved UVision360’s 510(k) premarket submission for its Luminelle DTx Hysteroscopy System. The system can be used for both hysteroscopy and cystoscopy, a procedure which involves visualizing the inside of the urethra and the bladder. Best of all, this technology can be used in a physician’s office to diagnose, and potentially even treat, a patient’s condition in the same visit.
“Since the best technology is typically only available in the operating room, many physicians and patients opt to skip the hysteroscopy and either perform a blind biopsy or go straight to surgery, without taking a good look inside of the uterus,” said Dr. Amy Garcia, Director of the Center for Women’s Surgery at the Institute for Hysteroscopy Training in Albuquerque, New Mexico. “An in-office system that is easy to use, prevents a blind biopsy and allows the physician to offer either a therapeutic diagnosis or a biopsy under visualization elevates the standard for uterine care.”
Visualizing the inner lining of the uterus and the bladder is key to accurately identifying any suspicious tissue and ultimately making a diagnosis. The Luminelle DTx Hysteroscopy System allows physicians to view the lining of these organs and perform a biopsy of the tissue, if necessary, which facilitates faster diagnosis and treatment for the patient. In addition to identifying the cause of abnormal bleeding, hysteroscopy may be used to implant or remove intrauterine devices and even investigate the potential cause of repeated miscarriage.
“Most operating room equipment is cost and space prohibitive for standard office use. We created an elegant and ergonomic system with visualization quality comparable to that of the OR, and that is comfortable for both physician and patient,” said Allison London Brown, CEO of UVision360. “Our system is a fully-integrated hysteroscopy/cystoscopy system with a value-based cost to provide better accessibility for the changing needs of today’s GYN. The combined features lead to the potential for better care for women, earlier detection, and improved health outcomes.”
According to the company’s website, their system is up to 75 percent less expensive than traditional endoscopic systems used to perform hysteroscopy and cystoscopy in the operating room. Hospital-based hysteroscopy systems can cost between $15,000 and $30,000.
It took just over two years for North Carolina-based UVision360 to take their device from concept to commercialization. The company also boasts a 95 percent US-based supply chain, with the Luminelle DTx Hysteroscopy System being designed in the country as well.