Assessment Listings
Independent clinical assurance for digital health tools.
All
AI/ML
Clinical Apps
Digital Therapeutics
| Tool | Use Case | Regulatory Status | Risk | Lifecycle Signals | |
|---|---|---|---|---|---|
|
PresciVA
NeuralView • Health
AI-driven early detection support for sepsis risk in ICU contexts.
|
Clinical decision support | SaMD • FDA Cleared | Moderate |
Updated Apr 2024
Maintains public lifecycle documentation.
|
See Report |
|
GlycoTrack
Owetix
Mobile CGM companion app for diabetes management workflows.
|
Diabetes management | FDA Cleared | Lower |
Updated Jul 2023
Reviewing QMS updates reported.
|
See Report |
|
CardioAI
HealthSys Analytics
Algorithmic support for early detection of AFib patterns.
|
Cardiology diagnostics | FDA Pending | Moderate |
Updated Feb 2024
Minimal post‑market transparency disclosed.
|
See Report |
|
Lifeguide
SenseWell
Behavioral health self‑management app with structured check‑ins.
|
Behavioral health | Class II MDR • CE Marked | Lower |
Updated Feb 2024
Provides transparent change log updates.
|
See Report |
|
NeuroScribe
Intellined
AI scribe tool generating structured clinical documentation.
|
Clinical documentation | SaMD • FDA Cleared | Moderate |
Updated Jan 2024
Providing data installation / audit report.
|
See Report |
Structured Assessment
Documented review of regulatory posture, evidence claims, and post‑market oversight signals.
Evidence Signals
Summary of validation data, stability, and outcomes evidence—kept readable for clinicians.
Lifecycle Transparency
Indicators for change control, monitoring, and transparency practices across the product lifecycle.