Unilife Corporation out of Lewisberry, PA won FDA approval to bring to market the Unitract 1mL single use insulin syringe. The speed of the self retracting needle can be controlled using the plunger to prevent unnecessary pain and potential splatter. Otherwise, the Unitract essentially operates like a standard one-handed safety syringe that makes sure the needle is inside the housing once injection is complete. According to the company, in anticipation of strong sales Unilife will be running its headquarters-based factory 24/7 and producing the device at an annual rate of 40 million units.
The Unitract(TM) range of 1mL syringes is the world’s first and only known syringe that allows operators to control the speed of passive (automatic) needle retraction directly from the patient’s body into the barrel of the syringe where it is locked in place. The products are well positioned to help prevent the transmission of blood-borne diseases such as HIV and hepatitis C via needlestick injuries, aerosol dispersal and syringe reuse. Primary target markets of the products include healthcare facilities, pharmaceutical companies and patients who self-administer prescription medication.
Unilife will now immediately file an additional 510(k) with the FDA seeking clearance for the Unitract(TM) 1mL Tuberculin (TB) Syringe. FDA clearance of the Unitract(TM) 1mL TB Syringe, which is a variant of the Insulin syringe product, will further expand the ability of the Company to market its range of safety syringes to U.S. healthcare facilities.
Press release: Unilife Receives U.S. FDA Clearance for Unitract(TM) 1mL Insulin Syringes…
Unilife company homepage…