Acorai receives Breakthrough Device Designation for their non-invasive intracardiac pressure monitor
Acorai is developing a first-of-its-kind, non-invasive intracardiac pressure monitoring (IPCM) device with a unique, patented hardware technology and proprietary machine learning system.
- Acorai is developing a first-of-its-kind, non-invasive intracardiac pressure monitoring (IPCM) device with a unique, patented hardware technology and proprietary machine learning system.
- The Breakthrough Device application was supported by preliminary data of 281 patients from their 400-patient Swedish pilot study, which demonstrated a strong correlation to the invasive gold-standard measurements of pulmonary pressure.
- Kasper Bourdette, Chief Operating Officer and Co-Founder added that "receiving breakthrough designation is a massive inflection point in our device development journey, and we are thrilled for the decision.
- Implications of the Breakthrough Device Designation:
Receiving the Breakthrough Device Designation accelerates the development and review process, underscoring the potential of Acorai to address unmet medical needs in heart failure management.