MedikalDevice

BrainBaseline Cognitive Assessment App

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BrainBaseline Cognitive Assessment App

Software-only mobile app (iOS) with game-based cognitive tasks covering memory, attention, processing speed and other domains. It is now offered mainly as a clinical-research platform; it is not a hardware device.

Key facts

ProductBrainBaseline (mobile cognitive assessment platform)
ManufacturerDigital Artefacts LLC (acquired by Clinical ink)
Intended usersHealthcare professionals
US FDA statusUnknown
Market statusAvailable

Main features

  • Cognitive tasks across eight domains (executive function, long-term memory, spatial processing, speed of processing, verbal memory, visual memory, visuomotor coordination, working memory)
  • Designed for repeated administration and tracking over time
  • Runs on iPhone/iPad
  • Research platform with Assess, Engage and Manage modules for clinical studies

Connectivity

Software app; data synced to the BrainBaseline/Clinical ink research platform.

AI and analysis software

The manufacturer does not describe built-in AI for this device. Because its data can leave the device, it can in principle feed separate analysis software; any such software is a distinct product with its own regulatory status.

Regulatory status in the United States

We could not confirm an FDA clearance for this exact model. No FDA clearance found. The manufacturer's materials present it as a research and cognitive-tracking tool, not a cleared concussion diagnostic.

Related guide: Medical Device AI Built-In vs Medical Cloud AI vs Medical Device Hybrid.

Sources

Profile verified against public sources in October 2026. Trademarks belong to their owners.