Ikerian (parent company of RetinAI U.S. Inc.) receives EU-MDR Certificate for four devices, its Ophthalmology Data Platform and AI models
June 24 2024 - 7:00AM
Ikerian AG (“Ikerian”) a leader in developing software solutions
for medical image and data management and artificial intelligence
(AI) in healthcare, today announced the registration as Class IIa
medical devices under the European Union Medical Device Regulation
(Regulation (EU) 2017/745) (EU-MDR) of 4 devices. The Certificate
applies to RetinAI Discovery®, a transformative healthcare platform
to unlock the power of digital data in Ophthalmology, and the
AI-based models to identify and quantify retinal layers, retinal
fluids and retinal biomarkers to aid in the diagnosis and
monitoring of diseases in Ophthalmology.
“The EU-MDR is among the world’s most robust regulatory
frameworks for healthcare technology, with the highest standards on
the clinical investigation and sale of medical devices for
patients,” said Dr. Carlos Ciller, CEO and co-founder of Ikerian
and RetinAI. “The significant number of AI-based certified products
we have obtained in Ophthalmology highlights our dedication to
innovation in the space to maintain high-quality standards in the
development of our products, together with our compliance of GDPR
data privacy and security laws in the EU. We are committed to
providing top-notch healthcare data and AI solutions to patients
and healthcare providers.”
The MDR replaces the former European Medical Device Directive
(93/42/EEC), including more rigorous requirements for clinical
evaluation and post-marketing surveillance. It is an
internationally recognized regulatory framework to ensure improved
device safety and requires device companies to provide clinical
data supported by clinical evaluation, risk management and quality
management systems. The long-standing MDD Certificates the company
obtained for its data platform and AI models - since 2021 - have
now been transitioned to MDR.
“This significant milestone is a reflection of our team’s hard
work and commitment to deliver safe and reliable medical devices
for healthcare,” says Dr. Sandro De Zanet, CSO and co-founder of
Ikerian and RetinAI. “The EU-MDR Certificate of RetinAI Discovery
and its AI models will firmly place confidence in healthcare
providers across the European Union that we are delivering the
highest standard of care to support the management of their
patients in Ophthalmology.”
To learn more or to request a demonstration of RetinAI Discovery
and its models for patient management, please visit
retinai.com/products/discovery
For further information please contact:
At the companyCarlos Ciller, PhD, CEO, Ikerian
AG and RetinAI U.S. Inc. - carlos@ikerian.com,
carlos@retinai.com
Media enquiriesSue Charles, Charles Consultants
- sue@charles-consultants.com +44 (0)7968726585
About RetinAI U.S.
Inc. www.retinai.com and
Ikerian AG www.ikerian.com
Established in 2017, RetinAI (Part of Ikerian AG), develops
software solutions to accelerate clinical, research and
pharmaceutical workflows globally using advanced machine learning
and computer vision.
Focused on the ophthalmology and optometry market, RetinAI
builds tools to collect, organize and analyze health data from the
eyes, enabling healthcare professionals to make the right decisions
sooner in healthcare. RetinAI's international team leverages its
clinical, technical, and scientific expertise to foster the
transition from reactive to preventive medicine for severe eye
diseases.
Follow RetinAI on LinkedIn:
https://www.linkedin.com/company/retinai/ Follow Ikerian on
Linkedin: https://www.linkedin.com/company/ikerian/ About
RetinAI Discovery®
RetinAI Discovery® and the AI modules for biomarkers, fluid and
layer segmentation, and quantification in retinal pathologies are
CE-Marked medical devices according to the Medical Devices
Regulation (EU) 2017/745. Discovery is a medical device cleared for
clinical use by the FDA. The AI modules for biomarkers, fluid and
layer segmentation and quantification in retinal pathologies are
for reference use only in the USA. Please be advised these tools
are not intended to be a substitute for medical advice, diagnosis
or treatment. We do not warrant any reliance on the accuracy,
completeness or usefulness of any content. Please read the Privacy
Notice (https://www.retinai.com/privacy-policy ) and Data
Processing Agreement
(https://www.retinai.com/data-processing-agreement ) for more
information. RetinAI Discovery and RetinAI are both trademarks of
Ikerian AG.