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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / March 2026 / K252360

510(k) cleared

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)

Anumana, Inc. · Mar 28, 2026 · K252360

FDA cleared the ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) from Anumana, Inc. on Mar 28, 2026 under K252360, a traditional 510(k). The device falls under product code SAT, Pulmonary Hypertension Machine Learning-Based Notification Software, regulated at 21 CFR 870.2380 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 29, 2025. The decision came 242 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Anumana, Inc. has 2 other decisions in the tracker over the last 12 months: K260300 (WatchMate Software), K253801 (ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)).

Questions & Answers

What did FDA clear under K252360?

K252360 is the FDA 510(k) for ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020), submitted by Anumana, Inc.. FDA's decision date was Mar 28, 2026, under product code SAT (Pulmonary Hypertension Machine Learning-Based Notification Software).

Who makes the ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)?

Anumana, Inc., based in Cambridge, MA, is the applicant of record for K252360.

How long did the K252360 review take?

FDA received the submission on Jul 29, 2025 and issued its decision on Mar 28, 2026, 242 days later.

← All decisions in March 2026

Sources