NeoMed Inc is all set to introduce a low dose solution which maintains consistency with other ENFit devices.
Woodstock, GA -- (ReleaseWire) -- 07/26/2018 --NeoMed has long been in the industry displaying innovative product design and commitment to patient safety and favorable outcomes. The low dose solution is undoubtedly compatible with those objectives.
A technical team of industry experts has worked together to identify a solution to address dose accuracy with a new ENFit low dose tip design. The design has been confirmed valid exhibiting the ability to deliver an accurate dose compatible with current practice with 95% of confidence, fits suitably into current practice and maintains consistency with other ENFit devices. The ENFit low dose tip syringe is expected to be ready for market introduction.
NeoMed offered their design to all syringe manufacturers in a royalty-free license arrangement, as well to the ISO working groups for inclusion into upcoming standard revisions at their discretion. Moreover, they have followed the GEDSA timelines and have worked diligently with all manufacturers within GEDSA to facilitate a smooth transition across all patient folks.
The company received clearance for the current NeoConnect Enteral Syringes with ENFit connector in 2015. NeoMed is currently one of the only two enteral syringe manufacturers that have received FDA 510 (K) clearance for enteral syringes with ENFit connectors.
Although NeoMed has been prepared to launch their ENFit product for several months, they have continued to support the delayed timelines laid by both GEDSA and other manufacturers, considering that they cannot ask facilities to transition until all of the devices used by their patient populations have ENFit versions.
FDA has been very involved in many of the dialogues and has requested that usability and technical studies being sponsored by GEDSA be completed in advance of any device release. All of that work is scheduled to complete within the next 60 days, and all results so far are entirely consistent with their internal findings.
For more information about pharmacy bottle adapter, visit https://www.neomedinc.com/?s=bottle+adapter.
NeoMed offers a full portfolio of neonatal catheters and kits, metric only oral syringes in both clear and amber, urinary drainage catheters, and kits, umbilical catheters, insertion kits, and breast milk tubes.