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Fujifilm Receives 510(k) Clearance for CAD EYE®, New AI-Powered Endoscopic Imaging Technology for Colonic Polyp Detection



Fujifilm Receives 510(k) Clearance for CAD EYE®, New AI-Powered Endoscopic Imaging Technology for Colonic Polyp Detection
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“Colorectal most cancers is the second essential purpose for many cancers deaths in U.S. males and females combined,3 no matter screening – primarily colonoscopy – being one of many essential reliable and environment friendly methods for many cancers prevention and early intervention,” says Tai Fujita, widespread supervisor, endoscopy, FUJIFILM Healthcare Americas Firm. “Daily we delight ourselves on delivering what we take into account is the perfect prime quality imaging and optics, arming endoscopists with the devices they need to battle this public effectively being issue. In the meanwhile, we’re thrilled to take {{that a}} step further with the introduction of CAD EYE, which has the potential to dramatically improve the usual of colonoscopy.”

Analysis level out CAD EYE can lead to considerable advances in colorectal most cancers detection and prognosis4 as a result of it:

  • Detects significantly further adenomas all through screening and surveillance as compared with typical high-definition colonoscopy with out AI assist, with none improve in course of time,4
  • 17% better adenoma per colonoscopy (APC) as compared with high-definition typical colonoscopy, 4
  • Detects colorectal neoplastic lesions at a stage akin to that of an expert and superior to that of a beginner.5,6

“As a gastroenterologist dedicated to affected individual care and safety, I’m heartened by the FDA’s approval of Fujifilm’s AI CAD polyp detection algorithm,” says Sravanthi Parasa MD FASGE, Gastroenterology, Swedish Medical Center. “This breakthrough not solely permits the early detection of precancerous lesions which will lead as a lot as colorectal most cancers however moreover significantly reduces the hazard of missed lesions, enhancing our precision and bettering affected individual outcomes. It marks a pivotal improvement in our potential to safeguard affected individual effectively being, reinforcing our dedication to embracing technological enhancements in gastrointestinal healthcare.”

CAD EYE will probably be utilized with every White Gentle Imaging along with Linked Shade Imaging (LCI®), Fujifilm’s enhanced visualization mode that differentiates the purple coloration spectrum to spice up mucosal visualization. LCI is clinically confirmed to reinforce visualization, detection, and documentation of colonic polyps.6,7,8 Every CAD EYE and LCI will probably be launched on the contact of a button, each on the endoscope take care of or the processor unit.

CAD EYE will in all probability be commercially accessible this spring 2024 following the completion of a restricted market evaluation. To check further about CAD EYE, click on on proper right here.

  1. Neumann H et al. 2021. PLoS One 16(8):e0255955, PMID: 34437563.
  2. Weigt J et al. 2022. Endoscopy 54(2):180-184, PMID: 33494106.
  3. https://www.most cancers/kinds/colon-rectal-cancer/about/key-statistics.html
  4. Desai M et al. 2023. Desai M et al. 2024. Am J Gastroenterol, PMID: 38235741.
  5. Misumi Y et al. 2023. J Clin Med 12(14):4840, PMID: 37510955.
  6. Rondonotti et al. 2022. Endoscopy 54(12):1171-1179, PMID: 35545122.
  7. Yoshida N et al. 2017. Endosc Int Open 5(6):E518-E525, PMID: 28596985.
  8. Suzuki S et al. 2023. Clin Gastroenterol Hepatol 21(6):1493-1502.e4, PMID: 36328306.

CAD EYE, ELUXEO and LCI are registered emblems of FUJIFILM Firm in different jurisdictions.

About Fujifilm

FUJIFILM Healthcare Americas Firm is an entire healthcare agency that has an intensive fluctuate of experience and expertise inside the detection, prognosis and remedy of illnesses. Fujifilm’s progressive medical imaging portfolio consists of choices for digital radiography, mammography, CT, MRI, ultrasound, gastroenterology, pulmonology, endosurgery, and minimally invasive surgical process. The award-winning Synapse® Enterprise Imaging portfolio provides healthcare professionals with the cross-departmental imaging and knowledge entry wished to ship a whole affected individual report. Fujifilm’s AI initiative, REiLI®, combines Fujifilm’s rich image-processing heritage with cutting-edge enhancements to encourage medical confidence and battle burnout. The In-Vitro Diagnostic portfolio provides the gold regular of molecular based immunoassay experience for liver surveillance, progressive medical diagnostic chemical compounds for essential laboratories and diagnostic chemical compounds for OEM white labelling merchandise. The company is headquartered in Lexington, Massachusetts. Click on on proper right here for further information.

FUJIFILM Holdings Firm, Tokyo, leverages its depth of information and proprietary core utilized sciences to ship “Price from Innovation” in our companies inside the enterprise segments of healthcare, provides, enterprise innovation, and imaging. Our relentless pursuit of innovation is targeting providing social value and enhancing the lives of people worldwide. Fujifilm is devoted to accountable environmental stewardship and good firm citizenship. For further particulars about Fujifilm’s Sustainable Price Plan 2030, click on on proper right here. For the yr ended March 31, 2023, the company had worldwide revenues of roughly 2.9 trillion yen (21 billion USD at an alternate price of 134 yen/dollar). For further information, please go to: