Pyng's FASTx infusion system cleared in US
This article was originally published in Clinica
Executive Summary
The US FDA has granted 510(k) clearance for Pyng Medical's FASTx sternal intraosseous device. The product is intended for adults and adolescents (12 and older) who require drugs or fluids for emergency resuscitation, such as shock or trauma victims. Intraosseous infusion involves injecting substances directly into the bone marrow. It is an alternative to conventional intravenous infusion when this cannot be carried out quickly enough. FASTx is rapid, reliable and safe, Vancouver, Canada-based Pyng says. The device is also CE marked for sale in Europe and approved in Canada. An older version, FAST1, received FDA clearance in 2008 (www.clinica.co.uk, 29 February 2008).