Zephyrus Innovations, a privately held medical device company focused on the design and manufacturing of safety syringes and closed system transfer devices, has announced that the US Food and Drug Administration has granted 510(k) marketing clearance for its VaporShield CSTD. The clearance allows the company to bring the product to market in the United States and marks an important milestone in its efforts to improve safety for healthcare professionals who handle hazardous medications.
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VaporShield CSTD is the newest addition to Zephyrus’ expanding portfolio of safety focused injection technologies. Closed system transfer devices play a critical role in reducing healthcare worker exposure to hazardous drugs, an issue addressed by USP 800 regulations in the United States. While existing devices help protect clinicians during intravenous drug administration, there have been limited solutions available for subcutaneous and intramuscular injections. VaporShield was developed to close that gap by providing a fully enclosed system from medication preparation through injection and final disposal.
The device maintains a true closed pathway throughout the entire process while also incorporating the core safety features of Zephyrus’ Aeroject auto retractable syringe. This design helps minimize the risk of needlestick injuries, which remain a significant occupational hazard in healthcare settings. By combining closed system protection with automated needle retraction, VaporShield is intended to offer a more comprehensive safety solution for frontline workers.
Market demand for CSTDs continues to grow as regulatory requirements and awareness of occupational safety increase. Industry estimates suggest that the global market for these devices could approach 2.7 billion dollars by the end of the decade, with the United States representing roughly 40 percent of total sales. Zephyrus believes VaporShield is well positioned to address unmet needs within this expanding market.
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Guy Reynolds, Executive Chairman of Zephyrus, said the approval represents a major step forward for healthcare worker protection. He explained that the harmful effects of repeated exposure to hazardous drugs have been well established, yet clinicians administering medications through subcutaneous or intramuscular routes have not had access to devices that fully address these risks. According to Reynolds, VaporShield creates an opportunity to significantly improve safety for millions of healthcare workers worldwide as they carry out routine patient care.
Reynolds also acknowledged the effort behind the product’s development and regulatory approval. He credited the achievement to the collective experience and dedication of the Zephyrus team and expressed appreciation to the company’s shareholders for their continued support throughout the process.
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