Corvida gets FDA approval to market first product

Corvida Medical, a Coralville medical device developer, has received U.S. Food and Drug Administration 510(k) clearance to market its first product, Halo.

The Halo closed system transfer device is designed to protect health care professionals from exposure to hazardous drugs.

The device received an ONB product code classification from the FDA, demonstrating there is no escape of hazardous drug or vapor concentration, no transfer of environmental contaminants, and microbial entry is prevented.

Health care workers are exposed to hazardous drugs every year, which can have serious health effects, including cancers, infertility and genetic mutations.

Closed system transfer devices protect health care professionals and patients from exposure to drugs by mechanically prohibiting the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system.

Corvida Medical's Halo will be commercially available later this year.

In September 2012, Corvida Medical received a three-year Small Business Innovation Research grant from the National Cancer Institute to help develop products such as the Halo CSTD.

Earlier in 2012, Corvida Medical received a $500,000 commercialization funding award from the Iowa Innovation Acceleration Program. The funding enabled the company to add top health care experts to its management team.

John Slump and Jared Garfield formed Corvida Medical as J&J Solutions when they were University of Iowa undergraduate students in the John Pappajohn entrepreneurial program.