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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 / K260332

510(k) cleared

EchoNext

Pathwai, Inc. · Jun 8, 2026 · K260332

FDA cleared the EchoNext from Pathwai, Inc. on Jun 8, 2026 under K260332, a traditional 510(k). The device falls under product code QXO, Cardiovascular Machine Learning-Based Notification Software, regulated at 21 CFR 870.2380 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 2, 2026. The decision came 126 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 Pathwai, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260332?

K260332 is the FDA 510(k) for EchoNext, submitted by Pathwai, Inc.. FDA's decision date was Jun 8, 2026, under product code QXO (Cardiovascular Machine Learning-Based Notification Software).

Who makes the EchoNext?

Pathwai, Inc., based in New York, NY, is the applicant of record for K260332.

How long did the K260332 review take?

FDA received the submission on Feb 2, 2026 and issued its decision on Jun 8, 2026, 126 days later.

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