Gynescope™ System

The Illumigyn Gynescope™ System uses a novel technology that we developed, creating high-resolution digital images with superior magnification that can substantially improve diagnostic accuracy.

Illumigyn is the first FDA-cleared remote gynecological platform. The Illumigyn Gynescope™ system digitally documents the cervix, vagina, and external genitalia, using high-resolution and superior magnification that enables more accurate pap smears.

Since the Gynescope™ system can be operated by any trained caregiver (OB/GYN, GP, Midwife, Nurse Practitioner, and Physician Assistant), it opens up the ability for women to be screened and diagnosed even in remote locations without physical access to physicians.

The images are uploaded to the cloud for reviewing and analysis by any doctor across the globe. With Illumigyn, the patient has more control and a close view of the procedure, with immediate access to a second opinion by an AI Clinical Decision Support Software (DSS)*, without undergoing another procedure.

Providing a higher standard of care:

• High-definition multi spectral imaging with an auto-focus camera that takes extremely high-resolution images over a wide field of view.
• Superior magnification & enhanced details.
• Consistent imaging results for clinicians of all types and experiences-including nurses and midwives-minimizing subjectivity.
• Results can be viewed in real-time on a tablet and shared with your patient.
• Full visibility of the cervix combined with device functionality enable clinicians to do whatever is necessary for the patient.
• Easy to set up, ergonomic and easy to use.
• Offers the ability to share images with colleagues.
• Upload and store images in the cloud for long term follow-up.
• For women patients who require examinations by female caregivers, their male doctors can invite a female doctor, or midwife to capture the images and then share for remote diagnosis.
• Illumigyn is creating the first-ever cervical HD multispectral image bank for better and faster insights for caregivers.
• FDA Cleared.
• HIPAA Compliant.

HD image bank for AI that enables:

Segmentation, training set, simple features training and deep learning*.

High-definition images:

Your OB/GYN or On-OB/GYN caregivers capture precise high-definition images for diagnosis and enabling to conduct advanced procedures.

Better examination:

Your OB/GYN or Non-OB/GYN clinician can show you images during the examination, making it easier for you to understand what is happening in your own body.

Easy-to-use system:

The easy-to-use system allows your caregiver-doctor, nurse, technician, end midwife-to record images and share them, privately, with specialist anywhere in the world.

Complete control:

You have complete access and control over your gynecological images and data, for follow-ups and second opinions.

SPECIFICATIONS:

Speculum:

• Speculum consists of 3 sizes:
  • Small
  • Medium
  • Large
• It is oval speculum and it mainly contains working channel and illumination.
• Single use Speculum.
• Shelf-life of speculum is 5years.

Gynescope- Digital Colposcope:

• It has own Id for every/each doctor to operate the Gynescope.
• It includes general check-up for External Genetalia, Vulva examination, Cervix Examination.
• It is Auto-focus and Auto-illumination device.
• Cervix is visible by Colposcope within 10 sec.
• It remains in same place for examination it will zoom in and out by magnification for screening of inside the cervix but it doesn’t go deep inside the cervix.
• By green light we would able to see blood vessels.
• It is a telemedicine device that means by capturing of cervix and observation of it can directly give the medication through device.
• No need of anaesthesia and no pain.
• Authentic acid is applied to the body for clear screening of the cervix. In other Colposcope gel is applied to the speculum for screening.
• Here Cloud-Based Technology is used for storing of images.
• Image is not compressed and we can easily send these images to another doctor for second opinion.
• We can also edit image for spotting abnormal cells.
• It can also store data of patient images upto 7 years.
• It can save in test drive.
• It is Auto-imaging and real-time video during the examination.
• No obstruction between provider and patient for ease of procedure.

Clinical Data:

• 70% of cervical cancer and precancerous cervical lesions are caused by HPV.
• In Indian studies approx. 207% of invasive cervical cancers are developed.
• In 100000 women 18.7% in 2020 was affected by cervical cancer.
• 45,300 were died in 2019.
• Second most common cancer among women is about 15-44 of age.
• HPV Vaccine not included in National Vaccine Programme in 2020.
• Primary prevention exists National Screening Programme for Cervical cancer in 2021.
• 2% have been screened in last 2 years.
• Fewer than 1% in 10 women has been screened for cervical cancer in last 5 years.

WHO Cervical cancer elimination strategy targets for 2030:

• 90% of girls fully vaccinated with HPV Vaccine at the age of 15 Years.
• 90% of women identified by cervical cancer and receive treatment.