First in class AI-based “fluid activity meter” in nAMD obtains CE Mark

RetInSight, a leader in AI-assisted retinal biomarker image analysis, has received its EU Quality Management System certificate according MDR 2017/745 on December 13, 2021.

Heidelberg Engineering GmbH and RetInSight GmbH intend to interface the RetInSight AI-based fluid monitor application with the Heidelberg Engineering product portfolio, using cloud exchange and application marketplace technologies.

Topcon Healthcare of Oakland, NJ, a leading provider of medical devices and software solutions for the global eye care community, announced today that it will partner with RetInSight GmbH, a developer of retina AI solutions based in Vienna, Austria. The two companies aim to develop a seamless interface between RetInSight’s AI-assisted retinal biomarker applications and Topcon’s market-leading¹ OCT devices and cloud-based data management solution, Harmony.

At this year’s EURETINA in Hamburg, Germany, there were several engaging presentations
during the Symposium Session that took place on the Friday, 2nd September on the
important topic of artificial intelligence (AI) tools for fluid monitoring in neovascular agerelated macular degeneration (nAMD).

The introduction of antivascular endothelial growth factor (anti-VEGF) fundamentally changed the treatment of neovascular age-related macular degeneration (nAMD).

Regulatory approval of a novel artificial intelligence-based tool that provides precise measurement of retinal fluid may introduce major paradigm changes in the monitoring of patients with neovascular age-related macular degeneration. “It is a precision management tool, a VEGF meter, which is what Philip Rosenfeld was asking for when anti-VEGF therapies started. More precisely, it is […]

After years of research, development and certification, the moment has now finally come to put the RetInSight Fluid Monitor in the hands of eye care specialists. With pleasure, we announce the launch of Fluid Monitor at Euretina 22! It will be featured in several lectures and symposia, among other in the symposium “How, when and […]

At EURETINA and ESCRS 2022, Heidelberg Engineering will present a new feature of its growing healthcare IT portfolio. Heidelberg AppWay, a novel gateway solution for secure data exchange, will allow seamless access to ophthalmic ‘apps’ that aid clinical decision making. For the launch of this workflow solution, Heidelberg Engineering has partnered with the companies RetInSight […]

TÜV SÜD Product Service has assessed RetInSight’s Quality Management System including the product documentation according to the requirements of MDR 2017/745. Based on the results of the assessment, RetInSight is recommended for certification according to MDR 2017/745 to the TÜV SÜD certification body for medical devices class IIa/medical device software for ophthalmology.

This gives RetInSight a unique selling proposition and opens up an outstanding market position in the field of AI-assisted retinal biomarker image analysis.