Raleigh-based UVision360 has achieved a dual-indication 510(k) clearance from the U.S. Food and Drug Administration for its all-in-one gynecological system LUMINELLE DTx Hysteroscopy System.
The dual indication opens the door for the system to be used clinically for hysteroscopy and cystoscopy. Hysteroscopy involves the insertion of a thin, lighted tube into a woman’s vagina to examine the cervix and the inside of the uterus. Cystoscopy also involves the use of a thin, lighted tube, but doctors use this procedure on men and women to examine the bladder and the urethra (the tube that carries urine from the bladder to the outside of the body). The LUMINELLE can only be used for female cystoscopy.
After receiving the dual indication, the company tapped top medical advisors to begin using the system for the first time. It will complete eight to 10 cases before taking the system to market later this month.“This is unique as the FDA typically only clears one indication for one submission, but we were able to garner clearance for both in one submission,” said UVision360 CEO Allison London Brown.
As used for hysteroscopy, the device allows the physician to view the uterine cavity using high-definition visualization technology and, if necessary, perform a biopsy under visualization. The device can also be used for cystoscopy, allowing the physician to view the bladder.
For London Brown, the system is a simpler way for women to find out what is going on in their bodies.
“Today, many surgeons will perform a hysterectomy based on symptoms without actually taking a thorough look at the uterus and without a clear diagnosis, and women are not armed with the right questions or comfortable enough to question their physician,” said London Brown. “We provide the clarity. This system allows women to get the most effective and thorough diagnosis when it comes to looking at a major, important organ in their body.”
In 2016 the North Carolina Biotechnology Center awarded UVision360 a $250,000 Small Business Research Loan to help advance the LUMINELLE technology.
Now, Brown and her team are seeking more opportunities in the gynecological market.
Key benefits of the LUMINELLE DTx Hysteroscopy System include:
- Camera uses the latest sensor technology, which allows the doctor to see the inside of the uterus from a greater distance, with clarity
- Accurate identification of suspicious tissue
- Biopsy under visualization, giving the doctor the ability to see what is really happening
- Faster diagnosis and recovery time than when performed in the operating room
- Therapeutic intervention during a single office visit
- Enhanced patient experience by staying in the office versus the operating room
(C) NC Biotechnology Center