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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 / DEN250025

510(k) cleared

Syncron-E

Autonomous Healthcare, Inc. · Jun 18, 2026 · DEN250025

FDA cleared the Syncron-E from Autonomous Healthcare, Inc. on Jun 18, 2026 under DEN250025, a direct 510(k). The device falls under product code QVC, Ventilator Waveform Analysis Software, regulated at 21 CFR 868.5896 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jun 23, 2025. The decision came 360 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 Autonomous Healthcare, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN250025?

DEN250025 is the FDA 510(k) for Syncron-E, submitted by Autonomous Healthcare, Inc.. FDA's decision date was Jun 18, 2026, under product code QVC (Ventilator Waveform Analysis Software).

Who makes the Syncron-E?

Autonomous Healthcare, Inc., based in Santa Clara, CA, is the applicant of record for DEN250025.

How long did the DEN250025 review take?

FDA received the submission on Jun 23, 2025 and issued its decision on Jun 18, 2026, 360 days later.

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