Pyng Medical has received Australian TGA clearance for its new and improved FASTx Sternal Intraosseous Device, as well as its new CRIC Kit Cricothyroidotomy device, effective immediately.
The 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 shock and trauma victims.
The company’s 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. The CRIC provides a rapid Cricothyroidotomy solution including illumination in a single compact device.
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 Sternal Intraosseous Infusion System.
“We have received Australian TGA, Health Canada and CE clearances for both the FASTx and CRIC, and have submitted our application for FDA 510K clearance for our next generation FASTx Sternal Intraosseous Device.”
Pyng Medical is the developer and manufacturer of the FAST1 Intraosseous Infusion System. With expanding markets in North America, Europe and Asia, the FAST1 has worldwide application for use with hospitals, emergency medical services and military forces.