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July 29, 2015

FDA grants 510(k) clearance for Corvida’s Halo closed system transfer device

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Corvida Medical to market its Halo closed system transfer device (CSTD) to aid healthcare professionals in the handling of hazardous drugs.

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The US Food and Drug Administration (FDA) has granted 510(k) clearance to Corvida Medical to market its Halo closed system transfer device (CSTD) to aid healthcare professionals in the handling of hazardous drugs.

The device also secured an ONB product code classification from the FDA, demonstrating no escape of hazardous drug or vapour concentration, no transfer of environmental contaminants and prevention of microbial ingress.

The Halo CSTD provides healthcare professionals with an air-tight and leak-proof closed system that is easy-to-use, with fewer pieces and less steps.

"Healthcare professionals appreciate Halo’s simplicity and we look forward to introducing it to the market."

Scheduled to be made commercially available later this year, the device features a simple design that improves comfort, while ensuring compatibility with current work procedures.

The CSTDs are said to be capable of protecting healthcare professionals and patients from exposure to hazardous drugs by mechanically prohibiting the transfer of environmental contaminants into the system and the escape of drug or vapour concentrations outside the system.

Corvida Medical president 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.

"The feedback on Halo has been phenomenal. Healthcare professionals appreciate Halo’s simplicity and we look forward to introducing it to the market."

According to the company, millions of healthcare workers are being exposed to hazardous drugs every year, which has serious health effects, including cancers, infertility, genetic mutations and other adverse health effects.


Image: The Halo closed system transfer device has been cleared by the FDA to protect healthcare professionals from exposure to hazardous drugs. Photo: courtesy of Barbaricino.

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GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
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