Chinese Regulators OK ArcScan Insight 100

ArcScan Inc.’s ArcScan Insight 100 has received National Medical Products Administration (NMPA) approval in China.

“We believe the ArcScan Insight 100 will help eyecare surgeons in China to better address the myopia epidemic which is predicted to affect 5 billion people globally by 2050 according to the journal Ophthalmology,” ArcScan CEO Andrew Levien said. “Surpassing the limitations of optical coherence tomography (OCT), our ultrasound solution provides comprehensive visualization of the anterior segment to help surgeons identify anatomical artifacts that could contribute to substandard post-surgical outcomes.”

Insight 100 enables eye surgeons to more accurately determine the appropriate sizing of phakic intraocular lenses (pIOLs) for placement behind the iris to treat myopia, commonly known as nearsightedness. According to the 2024 Global IOL Market Report published by Market Scope Reports, phakic IOL procedures will surpass 780,000 procedures globally this year, with an 8.8% projected growth rate through 2029.

ArcScan, Inc.’s Insight 100 is a computer-controlled high-frequency ultrasound device designed to equip ophthalmologists with precise, detailed images of the eye’s anterior segment. The Insight 100 has been granted U.S. Food and Drug Administration marketing clearance, CE approval, and NMPA Certification, and has been the subject of dozens of studies demonstrating the validity and applicability of computer-controlled ultrasound imaging. Within academic, military, and private clinics and institutions worldwide, applications continue to grow, complementing OCT limitations with precision ultrasonic imaging behind the iris. The company has 19 patents surrounding its approach to ophthalmic imaging and additional patient applications in process. 

“The Insight 100 has significantly improved outcomes for my patients,” stated Robert Lin, M.D., founder and CEO of IQ Laser Vision in California. “The most precise epithelial mapping technology with accuracy down to 1 um allows me to better assess the risk of keratoconus. Better visualization into the anterior segment and reproducible, easy and precise measurement of the sulcus, where the posterior phakic IOL (EVO ICL, Staar and pICL) allows better sizing of the pIOL to reduce potential risks of lens rotation, glaucoma and cataracts.”

ArcScan aims to globally advance and evolve medical imaging through use of intelligent, very high-frequency ultrasound technology. The company was founded in February 2007 in Golden, Colo.

References
National Medical Products Administration (NMPA): https://www.nmpa.gov.cn/zwfw/sdxx/sdxxylqx/qxpjfb/20240411150008130.html
Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11. PMID: 26875007. https://www.aaojournal.org/article/S0161-6420(16)00025-7/fulltext