Current status: Home potassium measuring device from prototype to approval
How up to date is the home potassium monitor from elyte diagnostics?
The first prototypes of our optical system have already been tested, optimised and significantly improved in several versions. We have reached decisive milestones in development. They are proof of technical feasibility and impressive performance.
Our strengths: location in Graz, practical relevance and medical expertise
As an Austrian start-up based at the Center for Knowledge and Technology Transfer in Medicine (ZWT) in Graz, elyte diagnostics has close ties with users, researchers, developers and medical experts.
Our greatest strength is our proximity to practical application: intensive exchange and cooperation with a wide variety of departments at Graz University Hospital, the Human.technologie Styria Cluster and the universities in Graz (Graz University of Technology and Medical University of Graz) give us an invaluable advantage.
The close connection between a deep tech company and patient-oriented problems gives rise to application-oriented solutions. Patients are always at the heart of elyte diagnostics’ development work.
Our goal is to help shape patient-centred diagnostics in the long term.
Challenge: Development and regulations
As a small, agile team, it is a challenging task to drive technical development forward quickly while complying with regulatory requirements (e.g. In Vitro Diagnostics Regulation, IVDR and FDA). Converting a functioning prototype into an approved medical device requires specific expertise, extensive documentation and strict adherence to quality standards.
Our path to approval: Strong partnerships
To overcome this challenge and make the process efficient, we rely on strong strategic partnerships. We work closely with experienced partners who support us throughout the development and approval process – from prototype to marketable product. These partners complement our expertise in areas such as industrialisation, quality management and series production.
Contact & Support
Support us: Share this information with patient organisations, doctors and those affected.
Partnerships: Become part of this important development in home diagnostics – contact us!