FDA News

Pying Medical Gets Special 510(K) Regulatory Clearance from FDA

(Feb 25, 2008)-- Pyng Medical announced the Company has received Special 510(K) regulatory clearance from the US Food and Drug Administration to market its new and improved version of the award-winning FAST1 Intraosseous (IO) Infusion System throughout the US, effective immediately.

FAST1TM is the most 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 a superior infusion tube that no longer requires the use of a removal tool. The product shipped to all non-FDA jurisdictions during the fourth quarter of 2007 and now begins shipment into the US.

"These improvements were implemented in direct response to feedback from Pyng's key customers based on real life applications on the battle field and EMS environments," said David Christie, President and CEO. "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 FAST1TM Intraosseous Infusion System. We look forward to showcasing further developments in our next generation FASTX Sternal IO System at leading industry events later this year," adds Christie.

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