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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 / September 2025 / K252105

510(k) cleared

Ligence Heart

Ligence Uab · Sep 26, 2025 · K252105

FDA cleared the Ligence Heart from Ligence Uab on Sep 26, 2025 under K252105, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 3, 2025. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

Ligence Uab has one other decision in the tracker over the last 12 months: K253535 (Ligence Heart).

Questions & Answers

What did FDA clear under K252105?

K252105 is the FDA 510(k) for Ligence Heart, submitted by Ligence Uab. FDA's decision date was Sep 26, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Ligence Heart?

Ligence Uab, based in Kaunas, is the applicant of record for K252105.

How long did the K252105 review take?

FDA received the submission on Jul 3, 2025 and issued its decision on Sep 26, 2025, 85 days later.

← All decisions in September 2025

Sources