We’re excited to have been selected for FDA’s READI-Home Innovation Challenge for our work detecting and predicting CRS.
READI-Home is part of CDRH’s Home as a Health Care Hub initiative, and it’s focused on device technologies that avoid hospitalization.
We’re honored to be among the first selected for our CRS AI model. This selection builds on a body of research we’ve developed with our partners, looking closely at how and when CRS presents following T-cell redirecting therapies. By detecting CRS earlier, Current Health can coordinate planned escalation for treatment if necessary, reducing hospitalization and allowing for more treatment in the community.
“T-cell redirecting therapies must be deliverable in community sites to be accessed by the patients who need them. For that to be possible, clinicians and program leaders need confidence in detecting adverse events like CRS earlier and facilitating early intervention while reducing unplanned hospitalizations and ER visits. We’re excited for the opportunity to engage with FDA to put patient safety and treatment accessibility at the center of the conversation.”
We look forward to engaging with FDA during the interaction phase as we refine the next generation of CRS detection. We’re grateful to the agency for creating this pathway, and to the clinical partners and patients whose collaboration got us here.
(Selection for READI-Home does not represent FDA marketing authorization.)