FDA 510(k) Clearance for ArcScan’s Insight™ 100 for Ophthalmic Imaging

GOLDEN, CO: February 18, 2016 — ArcScan, Inc., developer of state-of-the-art ophthalmic visualization technology, announces FDA 510(k) clearance for its ArcScan Insight™ 100 precision ultrasound device for imaging and biometry of the eye. Indicated for refractive surgical planning and evaluation of anterior segment pathology, the Insight™ 100 images and measures anterior chamber depth, angle-to-angle width, individual corneal layers, sulcus-to-sulcus width, and more—with micron level of precision.

Unlike hand-held ultrasound, the Insight™ 100 allows users to easily obtain reproducible images with stunningly high-resolution. The ArcScan Insight™ 100 delivers visualization of the anterior segment’s true anatomy, including areas such as behind the iris in ways that optical technologies can not. Epithelial thickness mapping with the Insight™ 100, one of its many applications, enables surgeons to confidently perform LASIK on patients they might have otherwise rejected because of suspect topography, and exclude candidates with early keratoconus who have normal-looking topography on less advanced imaging technology.

“We are thrilled to bring the ophthalmic community this unprecedented degree of precision to imaging and measurement of the anterior segment,” says ArcScan CEO Andy Levien. “The Insight™ 100’s breadth of capabilities delivers a host of new clinical insights to ophthalmic surgeons. With the Insight™ 100, the ‘state of the art’ of ophthalmic imaging has been redefined.”

According to John D Sheppard, MD, MMSc, President and Managing Partner of Virginia Eye Consultants, “The ArcScan Insight™ 100 is going to revolutionize corneal as well as cataract refractive surgery. It offers unmatched biometric precision of all anterior segment anatomy without shadows, allowing me to see corneal structures at a resolution that other diagnostic technologies simply can’t equal. This is the next generation of anterior segment imaging and the evolution of ultrasound.”

“Beyond refractive surgery, ArcScan has tremendous potential for use in cataract surgery and IOL planning with ability to image the capsular bag and anterior segment anatomy in a clean, reliable, and repeatable fashion,” says Ike K. Ahmed, MD, head of the ophthalmology division at Trillium Health Partners, Mississauga, Ontario. “We are and will continue to see greater usage in glaucoma diagnostics with the ability to image beyond where optical devices cannot—the ciliary body and suprachoroidal space—which will also help in surgical planning and postoperative assessment of new MIGS devices.”

To learn more about the ArcScan Insight™ 100 for anterior segment imaging or to schedule a demonstration, visit www.arcscan.com, email info@arcscan.com, or call +1 877.363.7226 (+1 720.399.8500 from outside the US). Visit the ArcScan team at AECOS in Aspen, CO, February 28-March 2, 2016; and at ASCRS in New Orleans, LA, May 5-May 8, 2016.

About ArcScan: ArcScan develops smart visualization technology and continually evolving ultrasound to provide ophthalmologists with new insights into the true anatomy of the anterior segment of the eye, including areas behind the iris. Arcscan’s mission is to enable better medicine in ophthalmology by driving improved outcomes in refractive, corneal, cataract, and glaucoma surgery.

We are very proud to announce that we have received our FDA 510(k) clearance!  To learn more, please click here:

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