Pyng Medical has received European CE Mark regulatory clearance to market its new and improved FASTx Sternal Intraosseous device in Europe, effective immediately.
Pyng Medical’s FASTx Sternal Intraosseous device has been 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.
Pyng Medical claimed that FASTx Sternal Intraosseous device is a safe alternative to conventional IV infusion providing lifesaving vascular access for fluid and drug resuscitation in shock and trauma victims. It 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 received both Health Canada and CE Mark approvals, and submitted our application for FDA 510K clearance for our next generation FASTx Sternal Intraosseous Device.”