Humedics receives ISO 13485 certification
Milestone for market entry of LiMAx test for liver function diagnostics
Humedics has established a Quality Management System (QMS) according to DIN EN ISO 13485 that covers all processes from design and development, via manufacturing to distribution. The QMS secures a consistently high quality and safety of the FLIP 2.0 analysis device and the corresponding breathing masks. At the same time the certified QMS is a pre-condition for the CE mark of the devices and demonstrates compliance with regulatory requirements. The certification audit was performed by Hamburg-based MEDCERT GmbH.
Erwin de Buijzer, CEO of Humedics GmbH, stated: “After the optimization of our FLIP devices for industrial scale production the ISO certification is an important milestone for the successful market entry of our innovative LiMAx test for liver function diagnostics.” The LiMAx test, together with the corresponding FLIP device and the diagnostic drug offers a clinically proven significant added value for patients with liver diseases and liver surgery.
Humedics has developed a breath test based in vivo diagnostic system (the LiMAx® test), which comprises a CE-marked medical device, breathing masks and a diagnostic drug. The LiMAx® test enables the clinician to quantitatively determine the individual liver function capacity of a patient within minutes. This allows for selection of treatment strategies and disease monitoring optimally adapted to the individual patients’ liver status. Current clinical applications, studies of which have already been published in highly respected peer-reviewed scientific journals, include diagnosis of the liver function before and after liver transplantation, liver surgery planning (e.g. assessment of the amount of liver to be resected without potentially increasing the risk of acute liver failure) and assessment of diseases such as liver fibrosis and cirrhosis. Over 20 trials in new indications such as the diagnosis of chronic liver diseases like non-alcoholic steatohepatitis (NASH) and the improvement of treatment decisions in liver oncology are ongoing. These investigator initiated trials impressively demonstrate the further potential of the LiMAx® test. The LiMAx® test is already being used in over 30 top-tier university clinics across Europe and more than 20,000 tests have already been performed. The LiMAx® test is commercially available in Germany, Austria and the UK.
Based on the specific metabolic action of the liver enzyme CYP1A2, which is expressed in all functioning hepatocytes, performing the LiMAx® test is a simple procedure. The diagnostic drug solution is administered intravenously, and the liver immediately starts to metabolize the drug into low dose paracetamol and 13CO2 (non-radioactive). The latter is exhaled in the breath, collected via a respiratory mask and guided to the LiMAx® system where, within 1-2 minutes following the injection, the LiMAx® IR laser spectroscopy system allows real-time and very precise quantification of the increase in 13CO2 content. The resulting LiMAx® value, measured in micrograms per kilo body weight per hour, is a reliable and repeatable measure of the maximum functional capacity of the liver.
Dr. Ralf Kohnen
Marie-Elisabeth-Lüders Str. 1
Tel.: +49 30 59008 3240 E-mail: email@example.com