Pharmaceutical Business review

Vidacare receives FDA clearance for bone marrow biopsy system

Expanding upon its technology combining a battery-powered driver and specialty needles to rapidly and safely access the intraosseous space, Vidacare said that it has developed the OnControl biopsy system to significantly advance the current technology used in bone marrow biopsy (trephine) procedures.

Philip Faris Jr., CEO and president of Vidacare, said: “The FDA’s approval of the OnControl biopsy system is a key milestone for Vidacare as well as patients requiring bone marrow biopsies. Bone marrow biopsies are the most frequently performed intraosseous diagnostic procedure in the US and around the world. Virtually unchanged for decades, the manual procedure causes pain rated as severe to worst possible pain by nearly 20% of patients participating in a recent study. The goal of the OnControl biopsy system is to provide greater clinician control while increasing the core capture rate and decreasing the discomfort experienced by patients and clinicians.”