Clinical and regulatory evidence for every device decision.
Literature, trials, device adverse event reports and patents in one API, for teams building AI for regulatory, clinical and quality work.
Device lifecycle
Design. Submit. Monitor.
The same evidence base, asked different questions at each point in the device lifecycle.
Design
- Which biomarkers are validated for this indication?
- What sensing methods have been published or patented?
- What failure modes are reported for similar devices?
Submit
- What clinical evidence exists for this device type?
- Which trials have studied similar devices, and on what endpoints?
- What does the literature say about safety and performance?
Monitor
- Are new adverse events being reported for this device type?
- What has been published about our device class this month?
- Does anything new change the benefit–risk picture?
Clinical evidence
The evidence behind a device type, in one table.
Trials, outcomes and published performance for a device class, each row linked to its source.
| Evidence | Finding | Source |
|---|---|---|
| Randomised trial | Higher adenoma detection rate than standard colonoscopy | Repici et al., Gastroenterology, 2020 |
| Meta-analysis | Gain held across randomised trials, mostly small adenomas | Hassan et al., Gastrointest Endosc, 2021 |
| Registered trials | 40+ studies of computer-aided detection | ClinicalTrials.gov |
EU MDR clinical evaluation
A literature review a notified body can reproduce.
Every search returns its query, sources, date and hits, so the search log writes itself.
| Date | Source | Query | Hits |
|---|---|---|---|
| 2026-09-22 | PubMed | "wearable ECG" AND "atrial fibrillation" | 214 |
| 2026-09-22 | Licensed journals | same, full text | 96 |
| 2026-09-22 | ClinicalTrials.gov | wearable ECG, AF detection | 38 |
Storke cut clinical evaluation timelines in half — grounding every assessment in the primary literature instead of hand-searching it.
FAQ
Questions from regulatory and clinical teams.
Do you cover FDA device data?
Can the output support an EU MDR literature review?
Are diagnostic accuracy studies included?
Enterprise on Valyu.
Private indexes on your firm's internal data, enterprise controls, and engineers who ship with you.
Talk to our team
SOC 2, Zero Data Retention, SSO with SAML or OIDC, scoped tenant isolation. US, EU, and UK deployment options, or dedicated in your VPC.
State-of-the-art retrieval on internal data: lab notebooks, internal reports, trial data, research archives. Agents run on your own research and every Valyu source, in one call.
When the API needs to go further, our engineers ship with you. Custom DeepResearch agents and vertical indexes tuned to your field.
For your next submission
Describe your device. We’ll find the evidence.
Trials, outcomes and published performance for devices like yours, each with its source.