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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 / K253593

510(k) cleared

Clarius Ejection Fraction AI

Clarius Mobile Health Corp. · Mar 2, 2026 · K253593

FDA cleared the Clarius Ejection Fraction AI from Clarius Mobile Health Corp. on Mar 2, 2026 under K253593, 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 17, 2025. The decision came 105 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 Clarius Mobile Health Corp. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253593?

K253593 is the FDA 510(k) for Clarius Ejection Fraction AI, submitted by Clarius Mobile Health Corp.. FDA's decision date was Mar 2, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Clarius Ejection Fraction AI?

Clarius Mobile Health Corp., based in Vancouver, is the applicant of record for K253593.

How long did the K253593 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Mar 2, 2026, 105 days later.

← All decisions in March 2026