Pyng Medical Corp. Receives US FDA 510(k) Clearance for FASTx(TM)
Published: Sep 02, 2010
VANCOUVER, BRITISH COLUMBIA--(Marketwire - September 01, 2010) - Pyng Medical Corp. (TSX VENTURE: PYT) announces today that it has received 510(k) clearance from the US FDA to market the FASTx™ Sternal Intraosseous Device. The company will now begin ramping up production to meet the anticipated demand for this next generation IO product.
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 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.
"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," said Robert Di Silvio, President and CEO. "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. "We also have both Health Canada and CE Mark approvals for FASTx™," adds Di Silvio.
About Pyng Medical Corp.
Pyng Medical Corp. commercializes award-winning trauma and resuscitation products for front-line critical care personnel. Pyng's expanded product portfolio includes a variety of innovative, lifesaving tools. With growing markets in North America, Europe and Asia, Pyng offers user-preferred medical devices for use by hospital staff, emergency medical services and military forces worldwide.
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Pyng Medical Corp.
Chief Executive Officer