FDA Grants ‘Humanitarian Use Device’ Status to Tool for PAH Biopsies, Supporting Possible Approval
The Endoarterial Biopsy Catheter (EABC), a tool for performing biopsies on lung artery walls to better evaluate pulmonary arterial hypertension (PAH) in people and responses to treatment, has been designated a humanitarian use device (HUD) by the U.S. Food and Drug Administration (FDA), its maker, Vascular Biosciences,…