Kardia 12L vs Bayesian Health

Bayesian Health is software inside a hospital's EHR for a sepsis program. K250680 covers a Sepsis Risk High flag for adults 18 and older, and the flag descends from the TREWS system developed at Johns Hopkins. A Breakthrough Device Designation preceded the clearance, and the vendor's May 12, 2026 release calls it the first continuous AI sepsis monitor to receive 510(k) clearance. Bayesian has no public price. Kardia 12L is a portable 12-lead ECG for a cardiology clinic, listed at $2,295 in USD, and the page does not say whether that fee recurs. AliveCor announced FDA clearance of new cardiac determinations in January 2026, bringing the 12L to 39. AliveCor launched the 12L in Europe on April 15, 2026. The 150-participant equivalence study behind the 12L is vendor-sponsored.