Redsense and the FDA held a Pre-Submission Meeting in Preparation for the 510(k) Premarket Submission for the Redsense Clamp

Redsense Medical announces that it held a 510(k) Pre-Submission meeting with the United States Food and Drug Administration (FDA) concerning the 510(k) Premarket submission for the Redsense Clamp.

The aim of the meeting was to ensure that there is a common view of the regulatory pathway and documentation needed for the 510(k) Premarket application process.

In the meeting, FDA officials provided constructive and supportive feedback and guidance concerning the regulatory requirements for the Redsense Clamp, which will be utilized in the coming 510(k) filing.

“We are pleased with the progress made thus far and the valuable feedback we have received from the FDA as we prepare to submit the 510(k) Premarket application for the Redsense Clamp.” says Pontus Nobréus, CEO of Redsense Medical AB.

Contact information

For more information, please contact: 
Pontus Nobréus, CEO
Telephone: +46 72-171 1264
E-mail: pontus.nobreus (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 Medicalsolves 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.