An AI wants to check your heart using your smartwatch
The FDA just granted Coredio its Breakthrough Device designation for software that estimates cardiac performance without electrodes or a catheter, relying only on a smartwatch and a blood pressure cuff. For heart failure patients, this could mean monitoring at home instead of in hospital, though the real questions about reliability still need to be settled.
practitioners › The Cardiac Performance Simulation Engine (CPSE) has also been accepted into the FDA's TAP program, an expedited review track reserved for devices considered a priority.
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