FDA Warning Letter Hits Kestra Rival, Raising Scrutiny Risk for ASSURE Defibrillator
A competitor in the wearable cardioverter defibrillator (WCD) market has received an FDA warning letter, according to a risk disclosure tied to Kestra Medical Technologies. Kestra management believes the letter did not target the rival's WCD unit, but the episode signals heightened FDA attention on the product category where Kestra's sole commercial product, ASSURE, competes.
LM Salvado•