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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 / June 2026 / K253015

510(k) cleared

Cognitive Function Neuroimaging (cfNI) Software (1.0.0)

VoxNeuro, Inc. · Jun 12, 2026 · K253015

FDA cleared the Cognitive Function Neuroimaging (cfNI) Software (1.0.0) from VoxNeuro, Inc. on Jun 12, 2026 under K253015, a traditional 510(k). The device falls under product code OLU, Normalizing Quantitative Electroencephalograph Software, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 19, 2025. The decision came 266 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 VoxNeuro, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253015?

K253015 is the FDA 510(k) for Cognitive Function Neuroimaging (cfNI) Software (1.0.0), submitted by VoxNeuro, Inc.. FDA's decision date was Jun 12, 2026, under product code OLU (Normalizing Quantitative Electroencephalograph Software).

Who makes the Cognitive Function Neuroimaging (cfNI) Software (1.0.0)?

VoxNeuro, Inc., based in Toronto, is the applicant of record for K253015.

How long did the K253015 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on Jun 12, 2026, 266 days later.

← All decisions in June 2026