March 3, 2008 - AirInSpace said last week it received FDA clearance to market its PlasmairT2006 mobile system as a medical device, the same technology that has been protecting astronauts aboard the International Space Station since 2000 against harmful particulates and microbes.
In October 2007, AirInSpace said it closed an $8.5 million Series “B” round of financing to fuel the company’s expansion into the U.S.
The maker says the device is different from other air cleaner products in the hospital market because most lack the “medical device” designation from the FDA. The mobile unit is said to catch and inactivate harmful microbes and is substantially more cost-effective than retrofitting hospital-building HVAC systems or even deploying less efficient mobile HEPA filter units that are not able to provide any level of germicidal efficacy.
The company says the device has been clinically proven to lower airborne biological loads and is now being used to combat nosocomial infection in high-risk areas of more than 100 hospitals and clinics throughout France, including hematology/oncology units and ICUs. The inactivation and germicidal effects of the plasma technology have been demonstrated even against one of the most resistant microorganisms such as Bacillus atrophaeus spores (anthrax surrogate).
The company said it will unveil a new product name for the PlasmairT2006 for the U.S. market at the upcoming Association for Professionals in Infection Control (APIC) annual meeting to be held in June in Denver, CO.
For more information: www.airinspace.com