Ideal Medical Technologies (IMT), developer of FUSION, a fully autonomous closed loop artificial pancreas system designed for use in the ICU setting, announced today that the U.S. Food and Drug Administration (FDA) has approved the second phase of its first in man safety study at Emory University Hospital.
Recognized by the FDA with Breakthrough Medical Device status, FUSION’s AI based glucose control system has the potential to dramatically impact patient outcomes, reduce nursing burden, and significantly reduce costs.
The first in man safety study began earlier this year, and the FDA’s review of data from the first patient group demonstrated FUSION’s ability to maintain glucose in the range of 70-180 mg/dL 97% of the time with 0% <70 mg/dL. Coefficient of variation was 20%.
“These impressive results represent a significant milestone for the company and demonstrate the feasibility of autonomous glucose management in the hospital setting,” said Dr. Leon DeJournett, IMT’s founder and Chief Medical Officer. “I am excited to be bringing this technology to fruition as more precise glucose management in the ICU has the potential to revolutionize patient care and outcomes, and the success of FUSION can point the way forward to better regulation of other bodily systems in the future.”
IMT intends to complete the first in man safety study by the end of 2022 and initiate the next safety study in ICU patients in Q1 2023. IMT is planning to bring the FUSION system to the hospital market in mid 2024.