WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / October 2025 / K231897

510(k) cleared

NeuroAlign software

Medivis, Inc. · Oct 21, 2025 · K231897

FDA cleared the NeuroAlign software from Medivis, Inc. on Oct 21, 2025 under K231897, a traditional 510(k). The device falls under product code HAW, Neurological Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jun 28, 2023. The decision came 846 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 Medivis, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K231897?

K231897 is the FDA 510(k) for NeuroAlign software, submitted by Medivis, Inc.. FDA's decision date was Oct 21, 2025, under product code HAW (Neurological Stereotaxic Instrument).

Who makes the NeuroAlign software?

Medivis, Inc., based in New York, NY, is the applicant of record for K231897.

How long did the K231897 review take?

FDA received the submission on Jun 28, 2023 and issued its decision on Oct 21, 2025, 846 days later.

← All decisions in October 2025