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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 / December 2025 / K250258

510(k) cleared

HeartBeam AIMIGo with 12-L ECG Synthesis Software System

Heartbeam, Inc. · Dec 8, 2025 · K250258

FDA cleared the HeartBeam AIMIGo with 12-L ECG Synthesis Software System from Heartbeam, Inc. on Dec 8, 2025 under K250258, a traditional 510(k). The device falls under product code DXH, Transmitters And Receivers, Electrocardiograph, Telephone, regulated at 21 CFR 870.2920 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 28, 2025. The decision came 314 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Heartbeam, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250258?

K250258 is the FDA 510(k) for HeartBeam AIMIGo with 12-L ECG Synthesis Software System, submitted by Heartbeam, Inc.. FDA's decision date was Dec 8, 2025, under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone).

Who makes the HeartBeam AIMIGo with 12-L ECG Synthesis Software System?

Heartbeam, Inc., based in Santa Clara, CA, is the applicant of record for K250258.

How long did the K250258 review take?

FDA received the submission on Jan 28, 2025 and issued its decision on Dec 8, 2025, 314 days later.

← All decisions in December 2025