FRANKLIN LAKES, N.J. — BD (Becton, Dickinson and Company), announced the U.S. Food and Drug Administration 510(k) clearance of its second generation BD Nano pen needle, designed for more reliable subcutaneous injection depth.

BD Nano 2^nd gen pen needles offer people who inject diabetes medications a more reliable subcutaneous delivery of their medication, designed to help people better manage their diabetes. Recent updates to the 2019 American Diabetes Association (ADA) Standards of Care highlight the importance of proper injection technique as part of good diabetes management. Proper injection technique is critical to insulin’s consistent absorption and there are several factors that can inhibit predictable insulin uptake, including accidental intramuscular injections, which can be caused by greater than required injection force.

BD Nano 2^nd gen pen needles help mitigate the risks resulting from user injection force variability through its contoured needle base and compensate for variable injection forces by first concentrating, then distributing pressure closely around the injection site (to support more reliable 4 mm target injection depth compared to other 4mm pen needles). The new design has demonstrated more reliable subcutaneous injection depth resulting in up to an 8-fold reduction in calculated intramuscular injection risk. Additionally, the new ergonomic design of BD Nano 2^ndgen makes it easier to use, from attachment to disposal, compared to other pen needles, and results in a more comfortable injection experience.

“The launch of BD Nano 2^nd gen pen needles reinforces BD’s commitment to providing the most advanced solutions possible for people with diabetes to help achieve better clinical management of insulin use,” said Stanislav Glezer, global vice president of Medical Affairs for BD. “In addition to the added clinical benefits the latest BD innovation brings, the new ergonomic pen needle features can help people feel more comfortable with their injection experience.”

This latest advancement to the BD Nano portfolio includes all the benefits its predecessor pen needle has, including BD’s 32G x 4 mm pen needle with 5-bevel PentaPoint comfort, which has been clinically shown to enter the skin more easily than other 3-bevel needles, providing a smoother and more comfortable injection, and extra thin wall EasyFlow technology that increases the medication flow rate, making injections easier. FDA 510(k) clearance will enable BD Nano 2^nd gen pen needles to be commercially available in mid-2019.