May 18th, 2022
The RetInSight Fluid Monitor now available for treatment support in patients with nAMD
Per April 30, 2022 the RetInSight Fluid Monitor fulfills all MDR 2017/745 requirements for class IIa medical devices as a Clinical Decision Support System (CDSS) for the monitoring of patients with neovascular age-related macular degeneration (nAMD). It is now ready for use in clinical practice and set off the much needed next evolutionary step in the management of patients with neovascular AMD in Europe.
The RetinSight Fluid Monitor is intended to be compatible with all leading OCT systems, starting with the Heidelberg Engineering SPECTRALIS® OCT platform, the Heidelberg Eye Explorer HEYEX image management platform and Heidelberg Engineering AppWay AI application access solution.
The RetInSight fluid Monitor is available for use in the European Economic Area and other countries that accept conformity with European health, safety, and environmental protection standards.
What is the RetInSight Fluid Monitor?
Fluid Monitor is a reliable, accurate AI-based “fluid activity meter” for the monitoring of patients with nAMD. It supports the optimization and personalization of therapy, with the aim to improve patient outcomes and increase clinical efficiency.
The AI-based software can be deployed by the OCT operator under the supervision of the eye care specialist, producing a comprehensive result by mouse click, while the patient is on site.
What does the RetInSight Fluid Monitor do?1,2
- It precisely identifies, localizes and quantifies retinal fluids in routine OCT images in a fast, objective and quantitative manner.
- It assigns a label to each OCT pixel, denoting its fluid type as intraretinal fluid (IRF) and subretinal fluid (SRF) and its location within the central 1-mm and 6-mm macular area, and provides reliable, accurate fluid measurements in nanoliters.
- The distinction of the specific fluid compartments is important, because of differences in the impact on visual function and the dynamics of fluid resolution during therapy with different regimens and substances.
- A retrospective analysis demonstrated high accuracy compared to human expert readers and published benchmarks, as well as high reliability at (narrow) 95% CI*.
IRF: 372.1 nanoliter
SRF: 48.3 nanoliter
PED: 630.0 nanoliter
PED segmentation included in the next Fluid Monitor software update
How (fast) are the results presented?
The RetInSight Fluid Monitor provides precision measurements in a concise format
- A pdf-report containing the IRF and SRF fluid volume measurements, together with the original and annotated images of the central OCT scan for a plausibility check by the eye care specialist.
By mouse click, while the patient is on site
- Whereas a certified OCT reader needs 2 hours and 49 minutes on average to annotate a conventional OCT volume with 97 B-scans and hundreds of millions of pixels accurately, such as is done during clinical trials for the regulatory approval of novel pharmaceuticals, Fluid Monitor completes this comprehensive analysis in only a few minutes*.
- In this respect, Fluid Monitor brings clinical trial quality to routine clinical care and thus, helps busy eye care specialists bridge the gap between clinical trial results and real-world outcomes.
How does it work?
The workflow will vary between different OCT platforms. Generally, it is as shown here:
Which potential value does the RetInSight Fluid Monitor bring?
Eye Care Specialists
- A solid basis for confident treatment decisions.
- The possibility to document the new hard datapoint facilitates long-term monitoring.
- Ability to the optimize and personalize treatment regimens, thereby reducing the risk and deficiencies of over- and under-treatment. 2-11
- A more efficient workflow, resulting in higher patient throughput.
Patients
- Shorter waiting times before getting an appointment with and seeing the eye care specialist.
- Less inconvenience and lower cost associated with travel and absence from work caused by over-treatment and reduced risk of vision loss caused by under-treatment.
- Increased trust and willingness to be compliant with the therapy resulting from receiving an understandable personal Fluid Monitor report as evidence of disease progression and treatment success.
Payer
- Gaining better insight into the budget spent on nAMD and improving resource allocation.
- Reducing the cost per patient. Combined with a better partient flow and throughput, this results in enhanced patient access.
Hospitals and Clinics
An opportunity to finetune internal treatment protocols, demonstrate quality of care and strengthen the reputation as innovative eye care provider, becoming or remaining:
- An attractive, competitive workplace for the AI-generation.
- A preferred eye care provider for patients and referring general practitioners.
- A valuable partner to insurance companies and/or Ministries of Health.
The RetInSight Fluid Monitor: the new tool to address the nAMD challenge
A heavy disease burden that continues to increase
The Current standard of care for treatment decisions
Using CST as a surrogate biomarker for disease activity
- Inaccurate fluid representation
- No segmentation of fluid compartments
- At best, only moderate correlation with visual acuity
Manual OCT interpretation
- Less reliable, subjective and qualitative fluid assessment
- Inefficient workflow
- Relatively low real-world therapeutic effectiveness
- Relatively poor (insight into) nAMD budget efficiency
The next evolutionary step
- Reliable, objective and quantitative IRF and SRF precision measurements by mouse click
- An AI-based “fluid activity meter” for the optimization and personalization of therapy in nAMD
- Delegable to the OCT operator
- Closing the gap between clinical trial results and real-world outcomes
- Improving (insight into) nAMD budget efficiency
About the Fluid Monitor logo
The RetInSight Fluid Monitor is an AI-based software solution for the detection, localization and quantification of intra- (IRF) and subretinal (SRF) and pigment epithelial detachment (PED) fluid at an ultrastructural level. This is expressed by the product logos and program icons.
PED segmentation included in the next Fluid Monitor software update
The symbol
The symbol shows in a graphically abstracted but medically correct way a typical OCT image for retinal fluid. The curved baseline represents the retina; the three ovals represent the fluid compartments embedded in the retinal layers. The waveform indicates the recurrence of fluid, the so-called fluctuations (fluid activity), over the course of the chronic progressive disease.
The shape
The basic form of the Fluid Monitor icon is the square. It stands for the therapeutic monitoring.
The superscript company logo acts as the sender: Fluid Monitor is a product of RetInSight.
The color
The basic color dark blue was chosen as an objective, calm and analytical color and one that associated with trust, honesty and reliability.
About RetInSight
The RetInSight Fluid Monitor is the first transformational AI-solution originating from the pipeline of RetInSight, founded in April 2020 as a spin-off from the Department of Ophthalmology & Optometry of the Medical University of Vienna, Austria. RetInSight was co-founded by Prof. Ursula Schmidt-Erfurth, one of the world’s leading retina-specialists and experts in retinal artificial intelligence. The company embarked on a challenging, but clear mission: helping achieve that living longer, which comes with a significant rise in the prevalence of age-related eye disease and vision loss, does not mean seeing less or not living in full.
To accomplish this goal, RetInSight develops AI solutions according to the highest quality standards. RetInSight has accomplished an extensive library of validated algorithms for use in (bio)pharmaceutical prospective and retrospective, clinical and scientific studies (Clinical Trial Services). Upon certification, these algorithms are made available for diagnostic screening and therapeutic monitoring in clinical practice as Clinical Decision Support Systems, after already having been applied in large population-based data sets and presented in publications in peer-reviewed journals. In this way, RetInSight helps bridge the gap between superior outcomes observed in clinical trials and inferior benefits obtained at high cost in real life, for the leading retinal diseases of our times.
How to get access to the RetInSight Fluid Monitor?
Until September 1, 2022, Fluid Monitor used in clinical practice by several eye care specialists in Europe as part of a first-user experience program.
If you want to be kept informed, please contact us (registration@retinsight.com). We will be in touch with you shortly.