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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 / March 2026 / K250655

510(k) cleared

Deep Capsule® (Deep Capsule US)

Digestaid - Artificial Intelligence Development SA · Mar 12, 2026 · K250655

FDA cleared the Deep Capsule® (Deep Capsule US) from Digestaid - Artificial Intelligence Development SA on Mar 12, 2026 under K250655, a traditional 510(k). The device falls under product code QZF, Gastrointestinal Capsule Endoscopy Analysis Software Device, regulated at 21 CFR 876.1540 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Mar 5, 2025. The decision came 372 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 Digestaid - Artificial Intelligence Development SA in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250655?

K250655 is the FDA 510(k) for Deep Capsule® (Deep Capsule US), submitted by Digestaid - Artificial Intelligence Development SA. FDA's decision date was Mar 12, 2026, under product code QZF (Gastrointestinal Capsule Endoscopy Analysis Software Device).

Who makes the Deep Capsule® (Deep Capsule US)?

Digestaid - Artificial Intelligence Development SA, based in Gondomar, is the applicant of record for K250655.

How long did the K250655 review take?

FDA received the submission on Mar 5, 2025 and issued its decision on Mar 12, 2026, 372 days later.

← All decisions in March 2026