SphingoTec has achieved a major milestone, having been re-certified according to ISO 13485 and receiving its first IVDR certificate for its IVD product sphingotest® penKid®. These certificates, awarded by the esteemed Notified Body TÜV SÜD Product Service GmbH, are testament to SphingoTec’s dedication to upholding the highest standards of quality and compliance with (EU) 2017/746 (IVDR).
sphingotest® penKid® is an invaluable aid in diagnosing kidney injury in critically ill patients with sepsis or septic shock. The product has met stringent regulatory requirements to ensure the utmost safety of patients and is IVDR-compliant and CE IVD-released, giving healthcare providers the peace of mind they need when making important medical decisions.
Dr. Angelo Moesslang, Managing Director and CFO of SphingoTec, is committed to ensuring compliance in all aspects of their clinical biomarker validation processes. By maintaining the highest standards of quality management, technical documentation, continuous biomarker evaluation, and product manufacturing, SphingoTec offers their partners valuable business opportunities and a distinct competitive advantage in the marketplace.
SphingoTec is dedicated to pushing the boundaries of diagnostic testing and is determined to continue collaborating with official regulatory bodies to obtain certifications for more products and expand existing certifications.
Through the success of sphingotest® penKid®, SphingoTec is blazing a trail of excellence in producing diagnostic tools that meet the highest standards of quality, safety, and regulatory compliance.
SphingoTec GmbH, based in Hennigsdorf near Berlin, Germany, is a commercial-stage diagnostic company focusing on developing innovative critical care biomarkers for the diagnosis, prediction and monitoring of acute medical conditions. Their proprietary biomarkers, such as Proenkephalin A 119-159 (penKid) and bioactive Adrenomedullin 1-52 (bio-ADM), are used to assess kidney function and endothelial function respectively in critical diseases and sepsis. SphingoTec’s markers are available on different IVD platforms, allowing for quick and reliable testing to aid in the treatment of patients.