Detalo Clinical™ – Medical Device CO Rebreather

Medical Device for Blood Volume Measurement

Blood Volume is an critical parameter the treatment of several critical diseases such as heart failure, kidney diseases and other illnesses that affect the circulatory system. Clinical evidence suggest that significant improvements exist if blood volume guided treatments are used by medical doctors. The Detalo Clinical™ is being developed as a medical device to be used in normal clinical flow and the use of CO rebreathing makes it available and affordable for use in most medical facilities.

Detalo Clinical™ is under development and is aimed for European launch soon.

Detalo Clinical™ will be certified as a medical device but is not intended to diagnose or treat illnesses. Blood volume measurements are meant to help the treating medical doctor make a better evaluation of patients and support their decision making.

Read more about Detalo Blood Measurement Devices
Detalo Clinical Blood Volume Analyser

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 in 2022.

Will be certified as a Medical CE Certified Device

The Detalo Clinical has been certified according to the following 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 certificate covering the following detailed standards:

IEC 60601-1:2005+A1:2012+A2:2020 with US national differencies
IEC 60601-1-2:2014+A1:2020, IEC 60601-1-6:2010+A1:2013+A2:2020
IEC 60601-1-8:2006+A1:2012+A2:2020, IEC 62304:2006+A1:2015

For final CE approval as medical device it will be reviewed by a notified body as soon as possible. All clinical data is already available.