FDA clears Calliphora vicina for maggot wound therapy

The FDA granted 510(k) clearance for Calliphora vicina, a blue-bottle fly, on June 12, 2026, for use in maggot debridement therapy [Ars Technica]. This decision follows a multicenter trial that enrolled 124 patients with diabetic foot ulcers and pressure injuries across eight US wound-care centers, reporting an 84% wound-closure rate after four weeks of maggot application, versus 61% for standard enzymatic debridement [FDA]. The device is classified as a Class II medical device and is marketed under the trade name “BlueMaggot™.” The FDA’s decision cites compliance with the agency’s sterility and bioburden standards, and it references the earlier 2020 clearance of Lucilia sericata, the green-bottle fly that pioneered maggot therapy. Calliphora vicina will be supplied as sterile, lyophilized maggots in sealed vials that dissolve in saline. The blue-bottle fly breeds more readily on synthetic substrates than Lucilia sericata, reducing reliance on seasonal carcass supplies [Ars Technica]. Manufacturers can now scale production in controlled-environment facilities, mitigating the need for alternative maggot sources. The trial’s 84% closure figure exceeds the performance of most enzymatic agents, giving wound-care teams a data-driven alternative to traditional maggot therapy [FDA].