Redsense Medical announces completion of Clamp usability testing
Redsense Medical announces the completion of the usability testing phase with the Redsense Clamp, entering the final stage towards CE marking. A study was conducted with Canadian home dialysis patients that used the Redsense blood leakage alarm together with the Redsense Clamp, under supervision of Dr. Christopher Chan, Director of Division of Nephrology and Medical Director at the University Health Network in Toronto, Canada. The results of the study will be published in a scientific article.
The next step is to finalize a usability report, to be reviewed by a Quality Assurance Provider, in order to CE-Mark the Redsense Clamp. The Clamp was also tested by German Intensive Care nurses, and that data has now also been received. All usability data is being analysed and compiled into a report, while in the meantime the last work to finalize and translate instructions for use, educational material, marketing material, and labelling have also begun.
“We are very excited that we are in the home stretch and are very grateful for the study team’s persistence and dedication” says Sebastien Bollue, CEO of Redsense Medical AB. “We now look forward to introducing the Clamp, which we expect to be later this quarter, with initial sales to our distributors in the UK and Canada.”
About Redsense Clamp
Redsense Clamp is developed to enable the Redsense blood leakage alarm to offer the highest possible patient safety by not only notifying the patient or caregiver that a blood was detected, but also help prevent significant blood loss by clamping the blood line. With the Redsense Clamp, this important functionality can be used alongside any dialysis machine, regardless of machine age or make.
Contact information
For more information, please contact:
Sebastien Bollue, CEO
Telephone: +46 72-171 1264
E-mail: sebastien.bollue (at) redsensemedical.com
Redsense Medical AB (publ), 556646-4862
ABOUT REDSENSE MEDICAL
Redsense Medical is a corporate group with operations mainly in Europe and the United States. The company has developed the Redsense System, an innovation used for monitoring and alarm in the case of blood leakage in connection with a hemodialysis treatment. Redsense Medical solves one of the most serious remaining safety problems within hemodialysis – to quickly detect Venous Needle Dislodgement and catheter leakage to minimize blood leakage. The system consists of a patented fiber optic sensor, designed for either venous needle or central venous catheter, which is connected to an alarm unit. From the very start, the development of the company's technology has been based on the demands and safety requirements of healthcare providers in the dialysis sector. The Redsense Medical share is listed on Spotlight Stock Market (REDS).