FDA Grants Class II Medical Device Clearance for Aerus Medical Guardian with ActivePure Technology
Tuesday, June 30, 2020 4:30 PM
Continuous, Active Air Purifier Uses NASA-inspired ActivePure Technology
DALLAS, TX / ACCESSWIRE / June 30, 2020 / Aerus, committed to providing cutting-edge technologies to create the healthiest indoor environments around the world, announced today that it received Class II Medical Device clearance from the U.S. Food and Drug Administration (FDA) for the Aerus Medical Guardian with ActivePure Technology, the first active air purifier for health care.
ActivePure is the most powerful surface and air-purification technology ever discovered. It can operate safely in occupied spaces and prevents recontamination in real time.
The Aerus Medical Guardian with ActivePure Technology, a free-standing, portable unit intended for use in professional health-care environments, is a 24/7 airborne contaminant reduction solution. The unit is the first of its kind, using NASA-inspired ActivePure Technology to purify the air continuously and actively without the use of ozone. The Aerus Medical Guardian with ActivePure Technology works safely 24 hours a day to protect the rooms where it is installed, even when occupied by large numbers of people.
The product cleared by the FDA is intended for medical purposes and is used to reduce staphylococcus epidermidis and erwinia herbicola bacteria; MS2 and Phi-X174 viruses; aspergillus niger fungal spores; and bacillus globigii bacterial spores from the air in a temperature-controlled professional health care-environment of 70 to 71 degrees Fahrenheit, 40%-45% RH.
While the market is saturated with a variety of capture-based air purifiers that rely on a HEPA filter, carbon or UVC light to reduce contaminants, the Aerus Medical Guardian with ActivePure Technology is the only FDA-cleared, real-time, active air-purification unit that quickly and powerfully eliminates airborne contaminants. It also disinfects safely without chemicals and without the need to capture the particles.
"Until now, there has not been a clear gold standard in preventative measures for air purification in health-care settings -- and the Aerus Medical Guardian with ActivePure Technology fills that void," said Joe Urso, chief executive officer of Aerus. "We believe our breakthrough technology will be a gamechanger in hospitals. Never have hospitals and medical facilities had an active air-purification system that works as quickly to reduce airborne pathogens as does the Aerus Medical Guardian with ActivePure Technology. Our powerful technology and affordable Aerus Medical Guardian unit offers health-care providers and their patients the higher level of protection they deserve."
Product Efficacy and Testing
The Aerus Medical Guardian with ActivePure Technology demonstrated in independent lab testing that it significantly reduces:
- MS2 bacteriophage RNA virus
- Phi-X147 bacteriophage DNA virus
- Staphylococcus epidermidis - gram-positive bacteria
- Erwinia herbicola - gram-negative bacteria
- Aspergillus niger fungal mold
- Bacillus globigii bacterial mold
Aerus Medical Guardian Technology
The Aerus Medical Guardian with ActivePure Technology provides continuous active surface and air purification through its unique, patented ActivePure Cell. An internal fan draws in air from the room where the unit is located. Air moves into the unit, where negative ions -- created from ion brushes -- charge incoming contaminants so that the oppositely charged carbon-coated HEPA filter media can be more easily entrained from the passing air. As air exits the filter, it passes through the ActivePure Cell, which contains two ultraviolet bulbs and a proprietary metal-based photocatalyst. This catalyst, when exposed to the energy from the UV bulbs, creates hydroxyl radicals and super ions, which enter ambient air to oxidize, mineralize and convert organic compounds into nonorganic forms. The released particles, known as ActivePure Molecules, fill the entire air space of the room, rapidly seeking and destroying microscopic pathogens, including RNA viruses, DNA viruses, bacteria, mold and fungi. Whereas, passive technology, also known as capture, air purifiers require pathogens to pass through the device.
Air purification systems with ActivePure Technology are currently also used in international health systems, including in Brazil, Canada, Italy, Poland, Portugal, Spain and Thailand.
"ActivePure technology's lab results have always proven that the technology destroys airborne DNA viruses, RNA viruses and bacteria. However, historically the vast majority of the public looked to air purifiers to remove pollutants and allergens - until COVID-19," Urso said. "While the Aerus Medical Guardian with ActivePure Technology is intended for health-care facilities, the same technology can be found in six of our 99-plus products. And, it is affordable and available for as little as $1-$2 a square foot. ActivePure Technology works so differently from the other capture-based technologies. The differences are in the timeframe and efficacy. While a capture-based technology may eventually work, it will take much longer and not be as effective. Simply put, the fastest and most powerful air purifiers made contain ActivePure Technology. Speed makes all the difference. Why take that risk?"
For more information, please go to https://AerusMedical.com.
ActivePure is the global leader in active, continuous surface and air purification systems for health care, commercial and public facilities and residential applications. Evolving from early-stage NASA designs, ActivePure Technology quickly, proactively and continuously minimizes the number of contaminants on all indoor surfaces and in the air. The systems produce special hydroxyls and ions, ActivePure Molecules, that destroy contaminants on contact, reducing exposure to diseases, including RNA and DNA viruses. Independent scientific data repeatedly show that the patented ActivePure Technology is the most powerful air and surface purification solution ever discovered, reducing over 99% of surface microorganisms and airborne contaminants. The ActivePure badge, displayed across the world, provides all those who enter a space peace of mind, knowing there is continuous 24/7 surface and air protection. In 2020, the Aerus Medical Guardian was registered and cleared as an FDA Class II Medical Device. In 2017, ActivePure was recognized by the Space Foundation as the only surface and air-purification technology to effectively adapt and market technology originally developed for NASA to improve the quality of life for all humanity, and it was inducted into the Space Technology Hall of Fame. ActivePure Technology is designed, engineered and produced in the USA and is a division of Aerus Holdings, LLC. For more information, please visit https://www.ActivePure.com/.
Since 1924, Aerus Holdings LLC (formerly Electrolux USA) has been committed to providing cutting-edge technologies and unparalleled service to create the healthiest indoor environments in North America and in over 70 countries around the world. During that time, Aerus products have helped protect over 50 million businesses and homes and have been honored in the Smithsonian. The Aerus family of companies includes Aerus, Beyond by Aerus, Vollara, ActivTek, Aerus Enterprise Solutions and AirScrubber by Aerus. Aerus is the exclusive worldwide owners of ActivePure Technology, the most powerful air and surface purification technology ever discovered, and the only one in its class recognized by the Space Foundation as Certified Space Technology and inducted into the Space Technology Hall of Fame. ActivePure Technology has been engineered by Aerus based on technology originally developed by NASA. For more information, please visit https://www.BeyondByAerus.com.
Jo Trizila, TrizComPR on behalf of Aerus and ActivePure
Email: [email protected]
Ann Littmann, TrizComPR on behalf of Aerus and ActivePure
Email: [email protected]