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DTx Hysteroscopy System

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Market Overview

doctor explains hysteroscopy

What is Hysteroscopy?*

Hysteroscopy as defined by the American College of Obstetricians and Gynecologists (ACOG) is:
Used to diagnose or treat problems of the uterus. A hysteroscope is a thin, lighted telescope-like device.  It is inserted through the vagina into the uterus. The hysteroscope transmits the image of the uterus onto a screen. Other instruments are used along with the hysteroscope for treatment. 

Why is it used?

One of the most common uses for hysteroscopy is to find the cause of abnormal uterine bleeding.  Abnormal bleeding can mean that a woman’s menstrual periods are heavier or longer than usual or occur less often or more often than normal.  Bleeding between menstrual periods also is abnormal.  Hysteroscopy also is used in the following situations:

  • Remove adhesions that may occur because of infection from past surgery
  • Examine the uterine cavity for potential causes of repeated miscarriage
  • Locate and remove an intrauterine device
  • Perform sterilization, in which the hysteroscope is used to place small implants into a woman’s fallopian tubes as a permanent form of birth control

*From the ACOG definition of Hysteroscopy

State of Care?

Based on known and current clinical data, 80% of current hysteroscopy procedures are performed in the Hospital or Ambulatory Surgical Center (ASC) setting**. These procedures are completed using standard endoscopic instruments and anesthesia similar to what is used for other out-patient procedures. These systems utilize an adapter for hysteroscopy procedures and total systems can cost between $15,000- $30,000. 

While other similar diagnostic procedures for both women and men’s health have moved into a clinic-based form, hysteroscopy has been slower to move into the office, primarily driven by the lack of enabling technology. Many gynecologists do not practice these procedures due to the prohibitive costs, ergonomic and space challenges of the current instruments in their office space, and the limited or poor visibility offered by systems today.

** Based on Ambulatory Medical Care Utilization estimate

Contact

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510(k) cleared for Hysteroscopy and Cystoscopy
Not for sale outside of the United States

Contact Details

info@luminelle360.com
158 Wind Chime Ct, Ste. 201
Raleigh, NC 27615
888-855-9360

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