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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 / July 2026 / K260980

510(k) cleared

cmAngio® V2.0

Curemetrix, Inc. · Jul 30, 2026 · K260980

FDA cleared the cmAngio® V2.0 from Curemetrix, Inc. on Jul 30, 2026 under K260980, 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 Mar 25, 2026. The decision came 127 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 Curemetrix, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260980?

K260980 is the FDA 510(k) for cmAngio® V2.0, submitted by Curemetrix, Inc.. FDA's decision date was Jul 30, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the cmAngio® V2.0?

Curemetrix, Inc., based in San Diego, CA, is the applicant of record for K260980.

How long did the K260980 review take?

FDA received the submission on Mar 25, 2026 and issued its decision on Jul 30, 2026, 127 days later.

← All decisions in July 2026