FDA approves Plasmair T2006 as medical device

Published: 10-Mar-2008

Technology used to protect astronauts aboard the International Space Station (ISS) against harmful particulates and microbes has gained FDA approval for use as a medical device.


The mobile Plasmair T2006 device, supplied through French company AirInSpace, captures and inactivates harmful and resistant biological particles from the air.

“We are extremely pleased that AirInSpace is permitted to introduce its mobile PlasmairT2006 by AirInSpace unit as an FDA-cleared medical device,” said AirInSpace ceo Laurent Fullana. “This sets us apart from the masses of other mobile ‘air cleaner’ products in the hospital market that lack this ‘medical device’ designation. We have something that hospitals all over the world need and want—a mobile unit that catches and inactivates 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 plans to unveil a new product name for the PlasmairT2006 for the US market at the upcoming Association for Professionals in Infection Control (APIC) annual meeting to be held in Denver, Colorado in June 2008. The rebranding is designed to help US hospital sites improve patient and staff awareness concerning infection control.

Separately, the company’s flagship product is a mobile air-decontamination unit called PlasmairT2006. Its performance 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: e.g., Bacillus atrophaeus spores (anthrax surrogate).

Meanwhile, Wade Tetsuka has been appointed as president of the company’s US operations headquartered in Sterling, Virginia. In October 2007, AirInSpace reported that it had closed an $8.5m (€6m) Series ‘B’ round of financing to fuel the company’s expansion into the US. The appointment marks part of the company’s bid to penetrate the US’s hospital market.

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