Pyng Medical, the developer and manufacturer of the FAST1 Intraosseous Infusion System, has received Health Canada regulatory clearance to market its new and improved FASTx sternal intraosseous device.
The company said that FASTx sternal intraosseous device is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) that require vascular administration of drugs or fluids to facilitate emergency resuscitation.
FASTx sternal intraosseous device is a rapid, reliable and safe alternative to conventional IV infusion providing lifesaving vascular access for fluid and drug resuscitation in cardiac, shock and trauma victims. The company’s lead clinical product has been re-engineered with an integrated, easy, pull-to-remove infusion tube, light and compact form factor made for single-handed use.
Robert Di Silvio, president and CEO, said: “These improvements were implemented in direct response to feedback from Pyng’s key customers based on real life applications on the battlefield, Hospital, and EMS environments. As part of our ongoing commitment to technology innovation we’ve achieved procedural efficiencies and further enhanced the ease-of-use for our market-leading FAST1 Intraosseous Infusion System.
“We have also submitted our application for European CE Mark and FDA 510K clearance for our next generation FASTx sternal intraosseous device.”