BHH member gMendel®, a Danish medical technology startup aiming to transform the diagnosis of genetic disorders for better disease management, announced today it has achieved CE marking for its Phivea® v1.0.0 platform, a novel screening technology for the detection of Klinefelter Syndrome.
Following the successful validation and a comprehensive performance evaluation, documenting the clinical applicability of its technology, gMendel® is now entitled to sell the Phivea® v1.0.0 platform in the EU, starting with a registration in Denmark. The Phivea® v1.0.0 platform will be marketed as an In Vitro Diagnostic (IVD) medical device product under the Directive 98/79/EC for In Vitro Diagnostic medical devices.
“The CE marking of the Phivea® v1.0.0 platform is a major milestone for gMendel®”, said Zoran Velkoski, co-founder of gMendel®. “In parallel with our strong patent portfolio strategy, our recently-obtained ISO 13485 certification and the CE marking pave the way for the commercial launch of more advanced products in the highly competitive IVD market, as defined in our product roadmap”, explained Zoran Velkoski.
About the Phivea® v1.0.0 platform
Phivea® v1.0.0 is an in vitro screening software tool for the diagnosis of Klinefelter syndrome based on DNA sequencing process. It offers screening tests capabilities, based on the data coming from third-party genome sequencers. Phivea® employs advanced Artificial Intelligence and customized Deep Learning architectures at all levels of the learning process, from feature extraction to assessment and follow-up care. Following a multi model fusion strategy, the Platform combines outcomes of individual models into a single, accurate medical interpretation. More about Phivea® v1.0.0 here.
About CE marking for medical devices
Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. The CE marking affixed to a medical device demonstrates compliance with the EU legislation in force and therefore can be made available for distribution or use, e.g. to a distributor, healthcare professional or patient. More about CE marking in medical devices here.