Detalo Clinical™ – Blood Volume Measurement Device
Medical Device for Blood Volume Measurement
Blood volume is a critical parameter to target in the treatment of several diseases such as heart failure, kidney diseases and other medical conditions that affect the circulatory system. Clinical evidence has demonstrated significant improvements in patient outcomes if blood volume-guided treatments are used by medical doctors. The Detalo Clinical™ was designed to easy being incorporated into normal clinical work-flows and the use of readily available tracer test gas makes it simple and affordable for use in most medical facilities.
Detalo Clinical™ has been submitted to Notified Body for certification according to the Medical Devices Regulation (MDR) and is aimed for a European launch in 2023.
Submitted to Notified Body for Medical CE Certification
The Detalo Clinical has been certified according to standards for medical devices:
IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance is an international standard that applies to the basic safety and essential performance of medical electrical equipment
IEC 62304 Medical device software — Software life cycle processes
Upon request, we can share our test certificates covering the detailed standards.
The Detalo Clinical™ has been submitted to notified body to certify that the device is fully compliant with the MDR and with the aim to place the device on the European market as a medical device.
Detalo Blood Volume Analyzers
Detalo automatically determines total blood volume, red blood cell volume and plasma volume in humans in a rapid, safe and precise manner.
The Detalo Performance is to be used for athletes and science and is available for purchase today. The Detalo Clinical is currently going through the medical certification procedures and should be available for clinical use soon.