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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 / K260780

510(k) cleared

HeartFocus

Deski · Jun 3, 2026 · K260780

FDA cleared the HeartFocus from Deski on Jun 3, 2026 under K260780, a special 510(k). The device falls under product code QJU, Image Acquisition And/Or Optimization Guided By Artificial Intelligence, regulated at 21 CFR 892.2100 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 10, 2026. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Deski in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260780?

K260780 is the FDA 510(k) for HeartFocus, submitted by Deski. FDA's decision date was Jun 3, 2026, under product code QJU (Image Acquisition And/Or Optimization Guided By Artificial Intelligence).

Who makes the HeartFocus?

Deski, based in Bordeaux, is the applicant of record for K260780.

How long did the K260780 review take?

FDA received the submission on Mar 10, 2026 and issued its decision on Jun 3, 2026, 85 days later.

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