We did it! We have regulatory approval!
Some of you might know how difficult it is to get a medical device to the market. The addition of a shift in regulatory framework on EU level and a pandemic made some say that the time plan for achieving a CE mark before May 2021 was impossible. But we are proud to announce that we did it. At WoCoVA tomorrow we are presenting ReLink Care, the first ever market ready breakaway connector for IV lines.
We are on an amazing journey, one that not only solves unmet clinical needs, but also pushes us to grow and improve. We humbly thank our network and all new friends this journey has brought to us as a part of our success. We are positive that this great achievement will open doors for us in the global market and we look forward to new productive collaborations in the future.
The last nine months have presented a fair share of obstacles and we heard ourselves repeat on so many occasions – “we are not failing here, not because of this”. One of the obstacles we faced was access to our users, the nursing community. But our network came through for us and we received excellent feedback from the usability study with >94% of the nurses saying they would use the device if it was available on the market.
The ReLink technology platform opens for a new class of breakaway connector devices that improve patient safety by decreasing the risk for injuries. It reduces spillage of fluids and loss of blood and supports accurate dosage to the patients thus making treatments more cost efficient. It reduces toxic exposure to healthcare professionals and time to restart a line, thereby saving valuable nursing hours.
It is day of pride and great joy for all of us at Tada Medical AB. Thank you and welcome to meet us at the 6th World Congress on Vascular Access (WoCoVA).