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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 / February 2026 / K253535

510(k) cleared

Ligence Heart

Ligence Uab · Feb 27, 2026 · K253535

FDA cleared the Ligence Heart from Ligence Uab on Feb 27, 2026 under K253535, 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 Nov 13, 2025. The decision came 106 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ligence Uab has one other decision in the tracker over the last 12 months: K252105 (Ligence Heart).

Questions & Answers

What did FDA clear under K253535?

K253535 is the FDA 510(k) for Ligence Heart, submitted by Ligence Uab. FDA's decision date was Feb 27, 2026, 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 K253535.

How long did the K253535 review take?

FDA received the submission on Nov 13, 2025 and issued its decision on Feb 27, 2026, 106 days later.

← All decisions in February 2026

Sources