Kardia 12L vs PERISCOPE

PERISCOPE predicts postoperative bacterial infection risk at 7 and 30 days from existing EHR data, and a surgical department is the buyer. Healthplus.ai B.V. in Amsterdam states CE marking as a Class IIa device under EU MDR, plus ISO 13485 and ISO 27001, and makes no FDA claim. Models are fitted per hospital, and the vendor puts implementation at 8 to 12 weeks. A PubMed search finds one paper on it, a retrospective multicentre study in the Netherlands and Belgium covering 253,010 procedures, with 30-day AUROC of 0.82, 0.82 and 0.91 at three hospitals and two authors from the vendor. Kardia 12L is an ECG recorder from AliveCor, which carries 19 FDA 510(k) numbers across its line and announced a European launch for the 12L in April 2026. A cardiology clinic buys that device. The two answer different clinical questions, infection after surgery for one and heart rhythm for the other.