BiGee Medical's Next-Gen Dry Eye Analyzer BVD6600 Series Receives FDA Clearance

Nov 25, 2024 10:48 CST Updated 10:48

Big Vision

Developer of Artificial Intelligence Analysis and Diagnosis Products for Ophthalmic Imaging

Source of the article: Eye Future ；Editor: Sophia

Reprint requirements: Can be reprinted 24 hours after the first publication, source must be cited.

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Recently,Big Vision MedicalIndependently DevelopedBVD6600 Series Dry Eye DetectorSuccessfully Obtained FDA Registration Certificate. This achievement marks the product's official entry into the international medical market, while also demonstrating the outstanding strength and innovative spirit of "Made in China" in the global medical technology field.

In 2023, the "Expert Consensus on the Application of Artificial Intelligence in the Clinical Diagnosis of Dry Eye (2023)" was officially published in Ophthalmology Advances by Big Vision, the founder of Suzhou Big Vision Medical Technology Co., Ltd.Professor Chen XinjianParticipated in the compilation as the drafting expert. It was mentioned that: Dry eye, as a common ophthalmic disease,Extremely high prevalence, involving a wide range of people, symptoms include dryness, foreign body sensation, burning sensation, eye itching, and vision fluctuation, etc.

In September 2023, Big Vision BVD6600 Series Dry Eye Detector Obtains Certification for Market Launch in China, is the fourth medical device registration certificate approved for the company after the ophthalmic imaging storage, processing and analysis system, fully automatic artificial intelligence OCT, and vision screening instrument. It adopts a large-size Placido ring,More comprehensively cover the cornea, integrating AI-assisted analysis functions, with a user-friendly interface and process design, bringing doctors and patients a better experience in dry eye examination.

BVB2000 Series Independently Developed by the CompanyOphthalmic Optical BiometerIt has also been approved for marketing in June 2024, achieving the integration of biometry and OCT functions.Ophthalmology OCT Imaging Auxiliary Diagnosis Software MIAS-3000Have successfully completed clinical trials,Expected to be the world's first to obtain a Class III certificate for OCT-assisted diagnosis, leading ophthalmic AI into a more comprehensive and precise new stage.

BVD6600 Series Dry Eye Detector

# BVD6600 Series Dry Eye Detector

BVD6600 is a product that adoptsLarge Placido DiskThe dry eye examination equipment of the solution is easy and user-friendly to operate, and can be used for patients.Tear meniscus height, Tear film breakup time, Meibomian gland, Eyelid margin, Eye redness, Lipid layer, Corneal stainingComprehensive examination,Achieve Precise Quantitative Analysis with Advanced Algorithms, providing objective examination results for the clinical diagnosis of dry eye syndrome.

Product Features

Wide Coverage:10mm Diameter Large Range Placido Ring Projection,Covering a wider corneal areaAutomatically switch to the default light source and magnification based on the examination mode, automatically identify the left and right eyes, without the need to manually change the lens.

AI Analysis Function:The equipment is equipped with advancedDeep Reinforcement Learning AI Algorithm Model, to achieve more reliable quantitative analysis and provide valuable examination basis for the clinical diagnosis of dry eye.

Full Functionality:One-stop CompletionComprehensive examination including tear meniscus height, tear film breakup time, meibomian glands, eyelid margin, eye redness, lipid layer, and corneal staining.

CanAutomatic Measurement of Tear Meniscus Height, as an important indicator for assessing the severity of dry eye syndrome;
By analyzing slit lamp videosAutomatic Measurement of Tear Film Break-up Time (TBUT)；
Fully Automatic Evaluation of Meibomian Gland Dysfunction (MGD) PatientsMorphological Changes of the Meibomian Glands, Automatically analyze the morphological parameters of meibomian glands through deep learning models to improve the accuracy and efficiency of diagnosis;
AI technology can provideTear Film Lipid LayerImaging to aid in the diagnosis of dry eye syndrome;
Auxiliary Corneal Staining Score, improving the convenience of corneal staining evaluation, and significantly enhancing diagnostic accuracy and efficiency.

Report is easy to understand:One-click printing of multiple comprehensive test results, with data and levels clearly visible, facilitates doctor-patient communication.

Built-in Questionnaire:Five mainstream dry eye questionnaires can effectively assist doctors in diagnosing dry eye.

Cloud Platform Architecture:Automatically create a dry eye examination record after the examination is completed, and scan the QR code to view the examination report on multiple terminals.

Long-term Follow-up:Through the intuitive comparison of images and results from previous examinations, it can better monitor disease progression and assist in evaluating treatment outcomes.

# Overview of the Dry Eye Detection Market

Dry Eye Disease (DED), also known as Dry Eye Syndrome (DES), Keratoconjunctivitis Sicca (KCS), and Dry Keratitis, is a multifactorial and progressive disorder caused by abnormalities of the tear film on the ocular surface and inflammation of the ocular surface.

Generally speaking, there is a tear film on the surface of the cornea at the very front of the eye. It plays roles in moisturizing, locking in moisture, and protecting the surface of the eyeball. Once the tear film can no longer stably remain on the ocular surface, the unprotected ocular surface cells will be damaged, leading to dry eye syndrome.

In the early stage of dry eye syndrome, symptoms often manifest as dry eyes, a feeling of having a foreign object in the eye, etc.;If timely and effective treatment is not taken, it can easily develop into refractory dry eye syndrome in the middle and late stages, leading to keratitis and corneal ulcers, and may even cause blindness.。Therefore,Early detection and treatment of dry eye syndrome are crucial.。

In the examination of dry eye syndrome, the Schirmer test and tear film breakup time are the most common.

In clinical practice, the Schirmer's test requires tear detection filter paper, where the test strip is placed inside the eyelid to observe the length of wetting, thereby determining whether the patient has dry eye syndrome. If the doctor anesthetizes the ocular surface, the function of the accessory lacrimal glands is being tested; without ocular surface anesthesia, the test evaluates the function of the main lacrimal gland.

In the direction of research and development and production of tear secretion test filter paper，Aibono, Haisen Bio, Liaoning Meizilin, Ophthalmic Vision, Ruilin Pharmaceutical, Tianjin Jingming, InnohealthCompanies such as Big Vision have laid out related products.

Another method of examination is to perform a tear film breakup time test, which aims to measure the duration for which a protective film forms on the surface of the eye and retains moisture. Clinically, this test generally requires the assistance of a slit-lamp microscope.

In the development of slit lamp microscopes, innovative enterprises in China includeSix Six Vision, Mok Medical, Suzhou Kangjie, Yide Medicaland so on.

In addition to the aforementioned products, there are also products such as tear component analyzers, meibomian gland function evaluators, corneal topographers, and tear secretion measurement devices used in clinical settings, along with some others.Comprehensive Dry Eye Diagnostic InstrumentAre being developed and launched, they can comprehensively analyze tear volume, tear film stability, eye congestion, lipid layer, and meibomian gland conditions. Many instruments have also incorporated AI technology.

In this direction, includingBig Vision, Chongqing Shangbang, Gaoshi Innovation, Kanghua Ruiming, Meidixin, Moting Medical, Ruihao Biotechnology, Shanghai Meiwok, Zhiding MedicalA group of innovative companies, including [company names], have entered the market.About 22 domestically produced products have been approved for marketing in China.。

Part of the Approved Dry Eye Detectors Made in China

Big Vision InnovationIn July this year, two dry eye diagnostic devices were launched, respectivelyGaush iDea FOS and Gaush iDea TopoGaush iDea FOS is a rapid, quantitative, and intelligent dry eye and ocular surface comprehensive analyzer that can complete single-eye dry eye examination in 15 seconds, providing clinicians with more accurate diagnostic evidence more efficiently. Gaush iDea Topo is a precise diagnostic device integrating dry eye and ocular surface comprehensive analysis, offering clinicians more ocular surface and tear film parameters for comprehensive diagnosis and evaluation.

November 2023,MediTrust EYESIS Dry Eye Comprehensive Examination InstrumentLaunched. This examination instrument adopts the AI intelligent program independently developed by Medixine, measuring TMH (tear meniscus height) in a non-invasive manner. At the start of the measurement, simply align the EYESIS Dry Eye Comprehensive Examination Instrument with the patient’s eye. The AI intelligent program will automatically mark the tear meniscus shape graphically within about 2 seconds, and display the tear meniscus height and tear meniscus area numerically.

As can be seen,The dry eye detection market has many competitors, and domestically innovative enterprises occupy the mainstream., a growing number of related products have emerged, providing the industry with a wealth of solutions.However, it should be noted that, overall,The technical barriers of dry eye detection equipment in the entire ophthalmic equipment system are not very high.。

Therefore, for many innovative companies, dry eye detection devices are just one part of their ophthalmic ecosystem product line.How to achieve synergy with the entire ecosystem is a key focus that enterprises should consider.; In addition,Through AI empowerment and continuous innovation, as well as providing a more accurate, convenient, and user-friendly testing experience, thereby increasing the added value of dry eye detection equipment, is also a direction that many companies are currently focusing on.

# About Big Vision Medical

Suzhou Big Vision Medical Technology Co., Ltd. was founded in 2015, the company...Ophthalmology AI-Assisted Diagnosis SystemBased on this, with the integration of artificial intelligence in ophthalmic OCT hardware as the market entry point, providing intelligent system solutions and offering one-stop eye health management services for individual users,Has obtained more than forty innovative achievements and patents.

The company took the lead in developing and completingMultimodal Artificial Intelligence Analysis and Diagnosis Software System MIAS, has obtained the Class II Medical Device Registration Certificate. The independently developed fully automatic artificial intelligence ophthalmic Optical Coherence Tomography (OCT) BV1000 is the first of its kind with complete independent intellectual property rights.Integrated Soft-Hard Artificial Intelligence OCT, meeting the diagnostic and screening needs of ophthalmic hospitals at all levels, obtained the Class II medical device registration certificate and license in August 2020.

The company has also developed towards optometry."Bright Lemon" Eye Health Management System, can be used in optometry centers, eyewear stores, grassroots ophthalmology and ophthalmology clinics.

In April 2024, the company successfully completed a financing round amounting to thirty million, which will further promote the company's development and innovation in the field of ophthalmic medical care. As of the publication date, the company's financing history is as follows:

# Global Leading Ophthalmic Device and Consumables Company

# Chinese Ophthalmic Devices and Consumables Companies

# Chinese Ophthalmology Medical Service Company

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