These Food and Drug Administration (FDA) developments recently came in:
eXciteOSA Device
On February 5, 2021, the FDA granted a de novo marketing classification for the eXciteOSA device(Signifier Medical Technologies), a prescription only device intended to reduce snoring and mild obstructive sleep apnea (OSA). Unlike other OSA devices used while patients sleep, the eXciteOSA device is the first device used while awake. The eXciteOSA device works by delivering electrical muscle stimulation through a mouthpiece that sits around the tongue; it is intended to improve tongue muscle function, which in time can help prevent the tongue from collapsing backwards and obstructing the airway during sleep. More information.
Breyanzi (lisocabtagene maraleucel)
On February 5, 2021, the FDA approved a biologics license application (BLA) for Breyanzi (lisocabtagene maraleucel; Juno Therapeutics), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least 22 other types of systemic treatment. Breyanzi is the third gene therapy approved by the FDA for certain types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL). Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma. The FDA granted Breyanzi Orphan Drug, Regenerative Medicine Advanced Therapy (RMAT), and Breakthrough Therapy designations. More information.