First-of-its-Kind Computer-Controlled Robotic Instrument Receives NMPA Certification
DENVER, May 13, 2024 (GLOBE NEWSWIRE) -- ArcScan, Inc., a global medical technology company dedicated to helping ophthalmologists improve vision with ultra-high frequency ultrasound diagnostic images, announced today that 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,” stated Andrew Levien, ArcScan CEO. “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.”
Using Insight® 100, eye surgeons can more accurately determine the appropriate sizing of phakic intraocular lenses (pIOL's) for placement behind the iris for treatment of myopia, commonly known as nearsightedness. According to the 2024 Global IOL Market Report published by Market Scope Reports, the leading market research provider for the eyecare industry, phakic IOL procedures will surpass 780 thousand procedures globally in 2024, with a projected growth rate of 8.8 percent from 2024 to 2029.
“The Insight® 100 has significantly improved outcomes for my patients,” shared Robert Lin, MD, founder and CEO, IQ Laser Vision, 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.”
About ArcScan Insight® 100
ArcScan, Inc.'s Insight® 100 is a computer-controlled high-frequency ultrasound device designed to equip ophthalmologists with precise, detailed images of the anterior segment of the eye. The Insight® 100 has been granted FDA 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. ArcScan, Inc. is headquartered in Denver, Colorado and has 19 patents surrounding its unique approach to ophthalmic imaging and additional patient applications in process. For more information about ArcScan, Inc. and Insight® 100, please visit https://www.arcscan.com.
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
CONTACT:
Karen Lundquist
klundquist@arcscan.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/00940ab6-93ca-416d-ba2d-45ad2ac8cb39