CORALVILLE, Iowa--(BUSINESS WIRE)--Emerging medical device firm Corvida Medical has received a 510(k) clearance from the US Food and Drug Administration (FDA) to market its first product, the Halo™ Closed System Transfer Device (CSTD), to protect health care professionals from exposure to hazardous drugs. The device received an ONB product code classification from the FDA, demonstrating no escape of hazardous drug or vapor concentration, no transfer of environmental contaminants, and prevention of microbial ingress.
Millions of health care workers are exposed to hazardous drugs every year. This exposure can have serious health effects, including cancers, infertility, genetic mutations, and other adverse health effects. CSTDs are designed to protect health care professionals and patients from exposure to these drugs by mechanically prohibiting the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system.
Corvida’s Halo™ CSTD is a novel concept in hazardous drug protection. Halo™ provides health care professionals with an air-tight and leak-proof closed system that is easy to use, with fewer pieces and fewer steps. It features a simple design that enhances comfort, while ensuring compatibility with existing work procedures.
The Halo will be commercially available in late 2015.
"We are focused on developing and introducing products designed to meet critical unmet needs, and have worked closely with thought leaders throughout our product development efforts. The feedback on Halo™ has been phenomenal,” commented Kent Smith, President and CEO of Corvida Medical. “Health care professionals appreciate Halo’s simplicity and we look forward to introducing it to the market.”
Corvida Medical innovates intelligent technologies that are designed to represent smarter solutions for the safe handling of hazardous drugs and excellence in design. The company addresses the problems inherent in current methods and develops smarter, simpler solutions to improve safety, productivity and quality for providers and patients.