IDx and Topcon sign exclusive AI
platform agreement for the U.S.
market

IDx, the company behind the first and only FDA-cleared autonomous AI
diagnostic system,joins forces with Topcon, a pioneering ophthalmic device
manufacturer, to tackle preventable blindness
 

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NEWS PROVIDED BY

IDx

Oct 22, 2018, 16:00 ET
 

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CORALVILLE, Iowa and OAKLAND, N.J., Oct. 22, 2018 /PRNewswire/ -- IDx, a leading AI diagnostics company, and Topcon, one of the world's leading ophthalmic device manufacturers, have signed an exclusivity agreement that will allow the companies to scale delivery of AI-based diagnostic solutions in the U.S. market.

The agreement grants exclusive rights to IDx in the U.S. as the only autonomous AI company permitted to sell its products with the Topcon NW400 – an easy to use, robotic fundus camera. Topcon continues to collaborate with other partners in the AI space for solutions that fall outside of this autonomous agreement.

In turn, IDx has agreed to assign Topcon's NW400 as the only robotic desktop fundus camera with less than a 55 degree field of view to be integrated with IDx-DR, an autonomous AI system that instantly detects diabetic retinopathy in fundus images.

"The importance of ease of use and consistently high image quality to successfully implement autonomous AI diagnostics in the front lines of care cannot be stressed enough," said Michael D. Abramoff, MD, PhD, founder and CEO of IDx. "Topcon is truly the innovative market leader in developing highly automated, consistent and easy to use retinal imaging systems. Together we can prevent visual loss and blindness by ensuring the safety, accessibility, and affordability of early disease detection."

Both companies have a history of innovation. IDx received FDA clearance for IDx-DR in April 2018, marking the first time the FDA has cleared an autonomous AI diagnostic system that does not require a physician to interpret images or results. Topcon introduced the first commercial back-of-the-eye spectral domain (SD) and swept source (SS) optical coherence tomography (OCT) systems and more recently announced the widely successful Maestro and Triton OCTs.

"Our partnership with IDx further solidifies our position as a pioneer in the eye care business," said Fumio Ohue, Managing Executive Officer of Topcon. "Our efforts to deliver better workflow solutions, imaging technology, and AI tools to eye care providers will be complemented by our work with IDx to bring autonomous diagnostics to a growing population of people with diabetes."

The recent FDA clearance of IDx-DR followed a clinical trial that demonstrated the autonomous AI system's ability to safely deliver specialty-level diagnostics in primary care settings. Novice operators received minimal training on how to capture images using the Topcon NW400 and IDx-DR's image quality AI. They successfully produced a diagnostic result 96% of the time by consistently capturing the high-quality images needed for IDx-DR to make a disease assessment.

Topcon recently announced the release and class II clearance of Topcon Harmony, a diagnostic data management application with vendor-neutral connectivity that enables software providers like IDx, EHRs and third-party manufacturers to seamlessly integrate diagnostic results into one central location for eye care providers.

About IDx
IDx is a leading AI diagnostics company on a mission to transform the quality, accessibility, and affordability of healthcare. Founded in 2010 by a team of world-renowned clinician scientists, the company is focused on developing clinically-aligned autonomous algorithms that detect disease in medical images. By enabling diagnostic assessment in primary care settings, IDx aims to increase patient access to high-quality, affordable disease detection.

The company's first product, IDx-DR, is an FDA-cleared AI-based diagnostic system designed for use at the front lines of care to detect diabetic retinopathy. IDx-DR is intended for use by health care providers to automatically detect more than mild diabetic retinopathy in adults (22 years of age or older) diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400, an easy to use and highly accurate robotic fundus camera.

IDx is developing additional AI-based diagnostic systems for the detection of macular degeneration, glaucoma, Alzheimer's disease, cardiovascular disease, and stroke risk. Prior to this current round, IDx had been funded by a group of private angel investors since the company's founding in 2010.

About Topcon
Topcon is a comprehensive ophthalmic device manufacturer within the worldwide ophthalmic community. It introduced the world's first commercial back-of-the-eye spectral domain (SD) and swept source (SS) optical coherence tomography (OCT) systems, which have driven innovation in eye-care.

More recently, Topcon Healthcare Solutions started to enhance not only its hardware but also its software solutions. To become the leader in diagnostic software, Topcon has developed a new strategic division whose primary objective is to create world-class software solutions for the eye-care industry and beyond. The company's products enable the collection and visualization of a wide range of imaging and clinical data while providing quantitative and clinical analysis capabilities.

Topcon's software gives clinicians access to patient exam data captured from OCTs, Visual Fields, Fundus cameras, and other Topcon and third-party devices. Topcon leverages its image management software called Synergy, where practitioners gain access to DICOM and non-DICOM information stored in a central, cloud-based environment. Additionally, Topcon now provides an integrated service that connects practitioners to an extensive network of reading services to assist in the management of sight-threatening eye diseases.

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IDx
2300 Oakdale Blvd
Coralville, IA 52241
Phone: 319-248-5620
www.eyediagnosis.net

IDx Media Contact:	Topcon Media Contact:
Linda Healan	John Trefethen
Amendola Communications	Vice President, Global Marketing & Product Design
1-404-725-7117	1-201-599-5100
Lhealan@acmarketingpr.com	jtrefethen@topcon.com

SOURCE IDx

Related Links

http://www.eyediagnosis.net

 

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IDx與Topcon簽署了面向美國市場的獨家AI平台協議

IDx，首家也是唯一一家獲得FDA批准的自主AI診斷系統的公司，

與開創性眼科設備製造商Topcon聯手，以解決預防失明
 

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NEWS PROVIDED BY

IDx

Oct 22, 2018, 16:00 ET
 

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愛荷華州CORALVILLE和新澤西州奧克蘭2018年10月22日電/美通社/

-領先的AI診斷公司IDx與全球領先的眼科設備製造商之一Topcon簽署了獨家協議，該協議將使兩家公司擴大在美國市場上提供基於AI的診斷解決方案。

 

該協議授予IDx在美國的專有權，因為IDx是唯一可出售Topcon NW400其產品的自主AI公司，Topcon NW400是一種易於使用的全自動眼底照相機。Topcon將繼續與AI領域的其他合作夥伴合作，尋求其它自主診斷系統的配合。

 

反過來，IDx同意將Topcon的NW400指定為唯一合IDX-DR配合的全自動桌面眼底相機，IDx-DR是一種可自動檢測眼底圖像中糖尿病性視網膜病變的自主AI系統。

 

IDx創始人兼首席執行官Michael D. Abramoff博士說：“要在護理的最前線成功實施自主AI診斷，易用性和一至穩定的高質量圖像的重要性不能忽視。 Topcon在開發高度自動化，穩定且易於使用的視網膜影像處理系統方面確實是創新的市場領導者。通過安全的早期疾病檢測，輕鬆使用及實惠的眼底鏡，我們可以共同防止視力喪失和失明。”

 

兩家公司都有創新的歷史。 IDx於2018年4月獲得FDA的許可，這是FDA首次許可不需要醫生解釋圖像或結果的自主AI診斷系統。Topcon推出了首個商業化的back-of-the-eye譜域（SD）和掃頻光源（SS）光學相干斷層掃描（OCT）系統，最近又宣布了廣獲成功的Maestro和Triton OCTs。

 

Topcon董事總經理Fumio Ohue表示：“我們與IDx的合作關係進一步鞏固了我們在眼保健業務領域的先驅地位。我們與IDx的合作將補充我們為眼保健提供者提供更好的工作流程解決方案，成像技術和AI工具的努力，從而為越來越多的糖尿病患者提供AI診斷。”

 

FDA最近對IDx-DR的批准是在一項臨床試驗之後進行的，該臨床試驗證明了自主AI系統能夠在基層醫療機構中安全地提供專業級診斷的能力。新手操作員可快速學會如何使用Topcon NW400和IDx-DR AI軟體拍攝圖像。他們始終能拍攝IDx-DR進行疾病評估所需的高質量圖像，從而成功在96％的準確性產生了診斷結果。

 

Topcon最近宣布發布Topcon Harmony的class II許可，Topcon Harmony是一種診斷數據管理應用程序，能讓軟體供應商們，如IDx，EHR和第三方製造商等軟件提供商可以將診斷結果無縫集成到眼保健提供商的一個中央位置。
 

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關於IDx
 

IDx是一家領先的AI診斷公司，其使命是改變醫療保健的質量，可及性和可負擔性。該公司由世界知名的臨床科學家團隊於2010年成立，致力於開發可在醫學圖像中檢測疾病的，符合臨床要求的自主算法。通過在基層醫療機構中進行診斷評估，IDx旨在增加患者獲得高質量，負擔得起的疾病檢測的機會。

該公司的第一項產品IDx-DR是經過FDA批准的基於AI的診斷系統，旨在用於糖尿病患者視網膜病變的一線護理。 IDx-DR旨在由醫療保健提供者用於在診斷為先前未診斷出患有糖尿病性視網膜病的成年人（22歲或更大）中自動檢測超過輕度的糖尿病性視網膜病。 IDx-DR已表明可與Topcon NW400一起使用，Topcon NW400是一種易於使用且高度精確的全自動眼底照相機。

IDx正在開發其他基於AI的診斷系統，以檢測黃斑變性，青光眼，阿爾茨海默氏病，心血管疾病和中風風險。自本公司於2010年成立以來，在本輪融資之前，IDx由一群私人天使投資人提供資金。
 

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關於Topcon

Topcon是全球眼科領域的綜合性眼科設備製造商。它引入了世界上第一個商業化的Back-of-the-eye譜域（SD）和掃頻源（SS）光學相干斷層掃描（OCT）系統，這些系統推動了眼保健領域的創新。

最近，Topcon Healthcare Solutions開始不僅增強其硬件，而且增強其軟件解決方案。為了成為診斷軟件的領導者，Topcon已經建立了一個新的戰略部門，其主要目標是為眼保健行業及其他行業創建世界一流的軟件解決方案。該公司的產品可以收集和可視化各種成像和臨床數據，同時提供定量和臨床分析功能。