Medical device firm Corvida Medical has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Halo Closed System Transfer Device (CSTD), which was designed to protect health care professionals from exposure to hazardous drugs.
Halo CSTD has been developed to protect health care professionals and patients from exposure to hazardous drugs through mechanically prohibiting the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system.
The company has obtained an ONB product code classification from the FDA for the device, which demonstrated capability to prevent escape of hazardous drug or vapor concentration, transfer of environmental contaminants and microbial ingress.
Halo is an air-tight and leak-proof closed system, which is easy to use, with fewer pieces and steps.
Corvida Medical president and CEO Kent Smith said: "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.
"Health care professionals appreciate Halo’s simplicity and we look forward to introducing it to the market."
The company plans to make the product available to customers by the end of this year.
The exposure to hazardous drugs will result in serious health effects, including cancers, infertility, genetic mutations, and other adverse health effects.