Tempus received FDA 510(k) clearance for Tempus ECG PH, software that reads a standard 12 lead electrocardiogram and identifies signs associated with pulmonary hypertension. The device does not require new hardware or a new test, since it runs against ECGs that are already being captured for other reasons. This adds to the cleared cardiovascular algorithm suite Tempus has been assembling, and pulmonary hypertension is a deliberate target because it is characteristically diagnosed late.
Our readClearance is the gate that separates a research grade algorithm from something a cardiology service can put into routine practice, and this one runs on data every hospital already has in volume. The deployment question is what happens downstream of a positive flag, because pulmonary hypertension confirmation requires right heart catheterization and a screening tool that raises referral volume without a matching diagnostic pathway creates a bottleneck rather than removing one. Ask for the sensitivity and specificity in the cleared indication and the population it was established in.