ArcScan's Ultra-High-Frequency Ophthalmic Ultrasound System Gains NMPA Approval Without Clinical Trials

May 21, 2024 10:11 CST Updated 10:11

ArcScan

Medical Device Developer and Distributor

Source of the article: Eye Future (Reference: Milestone) ；Editor: Bai Xiaofei

Reprint Requirements: Can be reprinted 24 hours after the first publication, source must be credited.

Recently, with the efficient cooperation of Beijing Marisun Medical Technology Co., Ltd.,Shanghai Haohai Biotechnology Co., Ltd.AgentArcScan, Inc.Independently DevelopedOphthalmic Ultrasound Biomicroscope (UBM)ArcScan Insight 100 Ultrasound Imaging Diagnostic System）Successfully obtained NMPA registration certificate through Clinical Evaluation Report (CER).。

▲Originated fromNational Medical Products Administration

Thus far, Insight®100Has obtained FDA market access approval, CE certification, and NMPA certification., and the effectiveness and applicability of computer-controlled ultrasound imaging have been validated in dozens of studies. The application of Insight®100 continues to grow in academic institutions, military, and private clinics worldwide.Its sophisticated ultrasound imaging technology effectively complements the limitations of OCT.。

In July 2021, asAnterior Segment Ultrasound Imaging Device“ArcScan Insight®100”The developer ArcScan, AnnounceSign a Stock Purchase Agreement with Shanghai Haohai Biotechnology Co., Ltd., facilitating an $11.15 million Series B preferred investment in ArcScan, Inc.

# ArcScan Insight 100 Diagnostic System

▲ArcScan Insight 100 Non-Contact Ultrasound Imaging Diagnostic System

ArcScan Insight 100 Non-Contact Ultrasound Imaging Diagnostic System is capable ofDisplaying ocular details with ultra-high resolution,Is a precisionVery High Frequency Ultrasound (“VHF-US”)Preparation，Can be widely applied to anterior segment scanning and imaging for cataract patients (intact capsular bag and zonules), glaucoma patients (angle measurement), ICL patients (sulcus-to-sulcus measurement/grading), SMILE/LASIK/PRK patients (scanning screening), and corneal conditions (corneal epithelial thickness/keratoconus/ocular trauma, etc.).。

The shooting range of the systemCan cover a complete corneal image from one side of the sclera to the other.(The probe moves in an arc on the surface of the cornea and always remains perpendicular to the corneal surface during scanning.)The complete anterior segment portion from the corneal epithelial surface to the posterior capsule(Covering the area behind the iris, the complete capsular bag, and suspensory ligaments, etc.), it reflects the true structure of the entire anterior segment through quick and simple operations.Accuracy reaches the micron level.。

Comparison of Imaging Effects：

▲ArcScan Insight 100 Imaging Results

▲OCTImaging Results

ArcScan Insight 100Unique size-setting functionCan assist clinicians in minimizing the risk of complications associated with ICL size in clinical practice.. Based on the direct measurement results of the posterior chamber of the eye by Insight 100,Select the most precise and suitable intraocular lens for the patient.The system ensures the measurement accuracy at the corneal level remains within 1.0 µm and the lateral measurement accuracy behind the iris stays within 0.12 mm, by generating liquid crystal-grade "HD" ultra-clear precision images (compared to the "analog" imaging effects of other ultrasound biomicroscopy systems).

The core technology of ArcScan Insight 100 isApplication of Robotic-Controlled Sensors and Fully Automatic Focal Depth Setting, maintaining a constant verticality and distance between the eye and the ultrasound probe. Each set of preoperative imaging scans includes scan results from seven meridians.Covers the complete imaging area of the target placement position of the intraocular lens haptics.At the same time, the imaging results can not only help determine the precise lateral space but also be used to detect whether there are ciliary body cysts or any other pathological structural abnormalities in the eye.Assist doctors in conducting preoperative assessments and diagnoses。

ArcScan Insight 100The advantages are as follows:：

Compared to handheldUltrasound Biomicroscopy (UBM)Different, Insight 100Advanced robotic technology has been applied., which can achieve precise control of ultrasonic beams through a computer;
No manual operation required, minimizing the errors caused by patient movement during scanning to the greatest extent;
50MHz ultrasound frequency, reachingUltra-high image resolution；
Comparison of Handheld UBM and Other Anterior Segment Imaging Devices,Imaging accuracy is 10 times higher。

# About ArcScan

ArcScan is designed toDevelopment of intelligent imaging technology and continuously updated ultrasound technology, providing ophthalmologists with the latest imaging technology for the true anatomical structure of the anterior segment of the eye, including the area behind the iris. ArcScan's mission is to create value in the field of ophthalmology by continuously improving the outcomes of refractive, corneal, cataract, and glaucoma surgeries.

# About Haohai Bio-Tech

Shanghai Haohai Biotechnology Co., Ltd. (referred to as "Haohai Biotech" together with its subsidiaries)Application of Biomedical Materials Technology and Genetic Engineering TechnologyA science and technology innovation enterprise engaged in the research and development, production, and sales of medical devices and pharmaceuticals, dedicated to providing innovative medical products to the market through technological innovation and transformation, integration of resources both in China and abroad, and large-scale production. The company aims to gradually achieve the import substitution of related pharmaceutical products and become a leading enterprise in the field of biomedical materials. The company was listed on the Main Board of the Hong Kong Stock Exchange on April 30, 2015, and on the Sci-Tech Innovation Board of the Shanghai Stock Exchange on October 30, 2019.Becoming the First "Hong Kong Stock + STAR Market" Biomedical Listed Company in China。

# AboutMindray

Beijing Mairui Sheng Medical Technology Co., Ltd. was established in 2008 and is aA Contract Research Organization (CRO) Focused on Clinical Trials and NMPA Registration, providing one-stop regulatory consulting services for partners throughout the entire process from product development to pre-market.