GynTools, obtained ISO 13485 certification in 2020 and Gyni acquired a CE mark in 2021. In 2023 Gyni received the Israeli AMAR certification. GynTools technology is protected with three (3) granted US patents, granted patents in Japan and Israel and pending patents worldwide.

Gyni is a multidisciplinary AI system. It is comprised of:

Smart sampler

- for vaginal discharge sample collection and preparation.


- an automated microscope that scans the sampler’s cassette.

User interface website

Cloud-based, machine learning algorithm

- trained by a unique archive of 12,000 screened & classified vaginitis conditions images.

Gyni imitates the line of thought of vulvovaginal disorder experts making their level of diagnosis available to non-expert operators, it does so by combining different inputs: Patient-reported complaints, Image analysis of microscopy images, and pH reading.

GYNI™ is the first Point-Of-Care vaginitis diagnostic tool for gynecologists and primary caregivers.

GYNI™ can diagnose the following conditions

- Bacterial Vaginosis
- Candida Albicans
- Candida Non Albicans
- Trichomonas Vaginalis
- Desquamative Inflammatory Vaginitis
- Cytolytic Vaginosis
- Vaginal Atrophy

GYNI™ Benefits

- Accurate and Rapid diagnosis of both infectious and non-infectious conditions
- One scanner can be used by multiple doctors
- Use of the scanner can be delegated to other clinic personnel
- Saving all paperwork and bureaucracy of samples sent to lab

1 What is GYNI?
The investigational test evaluated in this study is the GYNI™ rapid point-of-care system, an automated in-vitro diagnostic system, intended to aid in the diagnosis of vaginitis in symptomatic women, by qualitatively detecting the following vaginitis conditions or pathogens at the point-of-care:
(1) Bacterial Vaginosis (2) Candida albicans (3) Candida non-albicans (4) T. vaginalis (5) vaginal atrophy (also referred to as atrophic vaginitis or genitourinary syndrome of menopause) (6) aerobic vaginitis/desquamative inflammatory vaginitis and (7) cytolytic vaginosis
2 Why should you use GYNI?
Laboratory methods include cultures, a multiplex polymerase chain reaction (PCR) panel, and nucleic acid amplification testing (NAAT). Some rapid point-of-care tests are available, nevertheless, these tests are only for a subset of the related conditions, including BV and trichomoniasis. Each test can only diagnose a single cause, necessitating the conduction of multiple tests, thus increasing the turnover time and cost. Collectively, these findings suggest that current clinical practice is sub-optimal and indicate the need for a diagnostic modality that is efficient, cost-effective, allows for a wide range of diagnoses, and is usable during the clinic visit.
3 What are the benefits of using GYNI?
An insufficient in-clinic evaluation may result from the absence of suitable equipment (i.e., microscope), lack of proper training in the preparation and interpretation of a wet mount, time constraints, and lack of awareness that these measures allow improved detection of the causes of vaginitis1. As an alternative to microscope usage, providers can send vaginal samples for laboratory evaluation. Nevertheless, laboratory tests are aimed at detecting only infectious etiologies and cannot detect noninfectious conditions such as vaginal atrophy, desquamative inflammatory vaginitis (DIV, also termed aerobic vaginitis, AV), and cytolytic vaginosis. In addition, these methods are not available in many clinical settings, are expensive, time-consuming, and do not provide timely results, as many of these tests require a process that lasts from several hours15 to several days, thus not allowing a point-of-care diagnosis.


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