Pyng Medical has received US Food and Drug Administration (FDA) 510(k) clearance to market the FASTx sternal intraosseous device.
The FASTx sternal intraosseous device is used 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.
The 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 shock and trauma victims.
The device has been re-engineered with an integrated, easy, pull-to-remove infusion tube, light and compact form factor made for single-handed use.
Pyng Medical president and CEO Robert Di Silvio said that 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 technological innovation we’ve achieved procedural efficiencies and further enhanced the ease-of-use for our market-leading FAST1 Intraosseous Infusion System and we also have both Health Canada and CE Mark approvals for FASTx,” Silvio said.