FDA creates a new device category for AI that reads skin wounds without touching them

The FDA authorized a new type of medical device on May 21 through its De Novo pathway — reserved for genuinely novel device types with no existing predicate to compare against — creating an entirely new regulatory category for software that assesses skin wounds without touching them [s1][s2]. The first device cleared under that new category is SpectralMD's DeepView AI System, submitted for review in June 2025 and authorized roughly eleven months later [s1].

What the new category covers

The FDA's own definition of the category, now formally on the books as product code SHY under regulation 878.1840, describes "a software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment" that "uses a software algorithm to analyze optical or other physical properties of a skin wound without direct wound contact and returns characterizing information that may include classification, severity, or healing potential of the skin wound" [s2]. Two limits are built into the classification itself: the device is intended strictly for prescription use by healthcare providers, and it is explicitly "not for use as a standalone diagnostic device" — meaning it's designed to inform a clinician's assessment, not to replace it [s2].

Why creating a new category matters

A De Novo authorization is functionally different from the far more common 510(k) clearance route, which requires a manufacturer to show its device is substantially equivalent to something already on the market. Because no such predicate existed for non-contact, AI-assisted optical wound assessment, SpectralMD had to establish the entire category from scratch [s1][s2]. The practical consequence extends beyond this one device: with the SHY classification now established, future devices in this same category will be able to seek clearance through the faster, cheaper 510(k) pathway by citing DeepView as their predicate, rather than each needing to clear the higher bar of its own De Novo review [s2].

What the record does and doesn't tell us

The FDA's public classification record establishes what the device category is and is not intended to do, but it does not include performance data — no figures on how accurately the DeepView AI System classifies wound severity or predicts healing potential compared with a clinician's own assessment [s1][s2]. That kind of validation data is typically part of the full De Novo submission reviewed internally by the FDA rather than published in the public-facing classification summary. Readers should treat this as a regulatory and structural development — a new, defined pathway now exists for an entire category of wound-assessment AI — rather than a claim about how well any specific device in that category performs in practice.

Sources

• De Novo classification request DEN250028 — DeepView AI System — US Food and Drug Administration, 2026-05-21
• Device classification — product code SHY — US Food and Drug Administration, 2026-05-21