Blue Note Therapeutics’ Leukemia Digital Therapeutic Designated a Breakthrough Device

The FDA has granted its Breakthrough Device designation to Blue Note Therapeutics’ BNT200, a digital therapeutic for treating anxiety and depressive symptoms in adults with acute myeloid leukemia (AML) who are hospitalized for high-intensity induction chemotherapy (HIC).

The Breakthrough Device designation means that the company will have more access to the FDA’s experts to address topics as they come up during the premarket review phase. 

The prescription-only software is designed to synchronize with the HIC treatment regimen to help ease the stress on this subset of patients with AML and is not applicable to patients with AML undergoing outpatient treatment, the company said.

The digital therapeutic is intended to be used in the inpatient setting during the four to six weeks associated with HIC treatment.