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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 / K260300

510(k) cleared

WatchMate Software

Anumana, Inc. · Jun 15, 2026 · K260300

FDA cleared the WatchMate Software from Anumana, Inc. on Jun 15, 2026 under K260300, 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 Jan 30, 2026. The decision came 136 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Anumana, Inc. has 2 other decisions in the tracker over the last 12 months: K253801 (ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)), K252360 (ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)).

Questions & Answers

What did FDA clear under K260300?

K260300 is the FDA 510(k) for WatchMate Software, submitted by Anumana, Inc.. FDA's decision date was Jun 15, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the WatchMate Software?

Anumana, Inc., based in Cambridge, MA, is the applicant of record for K260300.

How long did the K260300 review take?

FDA received the submission on Jan 30, 2026 and issued its decision on Jun 15, 2026, 136 days later.

← All decisions in June 2026

Sources