What FDA's medtech pipeline looked like through May 2026, in three lines.
1. AI radiology is the modal new 510(k)
| Period | Most-cleared 510(k) product code | Clearances |
|---|---|---|
| April 2026 (latest complete) | QIH — Automated Radiological Image Processing Software | 8 |
| April 2026 total 510(k) clearances | (all codes) | 266 unique K-numbers |
"AI in medtech" is no longer forward-looking; it's the modal new connected device shipping in a typical month.
2. 12 brand-new Class II categories born in 2026 YTD
Each De Novo grant creates a brand-new product code that subsequent 510(k) submissions can then reference as a predicate. The 2026 YTD list spans seven advisory committees, fresh through 2026-05-21:
| Advisory committee | De Novo grants 2026 YTD |
|---|---|
| Neurology | 2 |
| Gastroenterology / Urology | 2 |
| General & Plastic Surgery | 2 |
| Ear Nose & Throat | 2 |
| Cardiovascular, General Hospital, Physical Medicine, Radiology | 1 each |
| Total 2026 YTD | 12 |
| Cumulative De Novo grants all-time | 396 |
3. Section 524B is a hard gate for every connected device
The Consolidated Appropriations Act of 2023 added Section 524B to the FD&C Act. For any connected device, FDA now requires an SBOM and a documented secure-development lifecycle as a Refuse-to-Accept gate. Every QIH submission above passed through this.
What this means
- RA teams — SBOM + SDLC are no longer optional; budget for them on every connected-device program.
- BD & investor teams — De Novo grants are the structural unit of new BD opportunity. Each new code creates a one-to-many predicate landscape.
- R&D teams — the QIH grant cadence sets the bar for AI/ML radiology competitive intensity.
Editorial commentary on publicly available regulatory and public-database data. Not investment, legal, regulatory, or medical advice.