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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 / April 2026 / K253801

510(k) cleared

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)

Anumana, Inc. · Apr 7, 2026 · K253801

FDA cleared the ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) from Anumana, Inc. on Apr 7, 2026 under K253801, a traditional 510(k). The device falls under product code SHP, Cardiac Amyloidosis 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 Nov 28, 2025. The decision came 130 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), K252360 (ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)).

Questions & Answers

What did FDA clear under K253801?

K253801 is the FDA 510(k) for ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040), submitted by Anumana, Inc.. FDA's decision date was Apr 7, 2026, under product code SHP (Cardiac Amyloidosis Machine Learning-Based Notification Software).

Who makes the ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)?

Anumana, Inc., based in Cambridge, MA, is the applicant of record for K253801.

How long did the K253801 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Apr 7, 2026, 130 days later.

← All decisions in April 2026

Sources