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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 / May 2026 / DEN250028

510(k) cleared

DeepView AI® System

Spectralmd, Inc. · May 21, 2026 · DEN250028

FDA cleared the DeepView AI® System from Spectralmd, Inc. on May 21, 2026 under DEN250028, a direct 510(k). The device falls under product code SHY, Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment., regulated at 21 CFR 878.1840 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jun 27, 2025. The decision came 328 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 Spectralmd, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN250028?

DEN250028 is the FDA 510(k) for DeepView AI® System, submitted by Spectralmd, Inc.. FDA's decision date was May 21, 2026, under product code SHY (Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.).

Who makes the DeepView AI® System?

Spectralmd, Inc., based in Dallas, TX, is the applicant of record for DEN250028.

How long did the DEN250028 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on May 21, 2026, 328 days later.

← All decisions in May 2026