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501k Clearance for Ergonomic Pen Needle for Optimal Injection Technique
The FDA has given BD 501k clearance for its second-generation Nano pen needle, designed for more reliable subcutaneous injection of diabetes medications.
Proper injection technique is vital for the consistent absorption of insulin, as highlighted in recent updates to the American Diabetes Association’s 2019 Standards of Care.
The contoured needle base of BD’s Nano 2nd generation pen needle minimizes the risks from users employing too great a force when injecting by concentrating then distributing pressure closely around the injection site. This helps to ensure a more reliable 4-mm target injection depth compared to similar pen needles.
In addition to decreasing the intramuscular injection risk, the pen needle’s new design is easier to use, from attachment to disposal, compared to other models.
BD Nano 2nd generation pen needles are expected to be commercially available by the middle of 2019.
Source: BioSpace, January 24, 2019