ConceptoMed AS has received FDA 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the LuerJack Slip syringes and the first LuerJack Lock 10ml syringe.
“We are very pleased to receive FDA 510(k) market clearance for our LuerJack Slip and Lock syringes. The FDA 510(k) market clearance for LuerJack Lock 10ml represents another important milestone in our global strategy and will open up potential of establishing a commercial presence of the LuerJack in the world’s largest single healthcare market, the US. The proprietary LuerJack connection/disconnection fluid transfer technology has potential in a number of applications, ranging from all syringes, blood gas syringes, pre-filled syringes and control syringes to connectors in general”, said Christian Mide, M.D., CEO and co-founder of ConceptoMed.
LuerJack – more than a syringe!
With continued global focus on reducing Healthcare Associated Infections (HAI), a recent study conducted by Research Institutes of Sweden (RISE) documents that LuerJack may play an important role in reducing the rate of contaminated injected medication in clinical settings.
LuerJack addresses human factor risk mitigation in aseptic procedures when handling medical connections, cannula hubs, spikes etc. – simply by its one-handed, non-twisting disconnection capability. The one-handed disconnection makes LuerJack user-friendly – just ”click and release” without twisting off.
Safety through simplicity!
By its design, the one-handed disconnecting syringe LuerJack supports an aseptic non-touch technique. The RISE study documents a 46% reduced contamination of injected medication, compared to today’s conventional available syringe designs. This may significantly reduce bloodstream infections.
A key contribution to a next-generation medical syringes and connectors may become the development away from using two hands during disconnections – enabling ergonomic, safe, non-twisting disconnection and aseptic handling of needle-less ports, needles, caps and any other connected devices.