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Last updated: June 13, 2026
Back to directoryRune Labs StrivePD medical AI product profile
Precision neurology platform for Parkinson's disease that combines StrivePD app data, Apple Watch symptom measures, clinician dashboards, clinical-trial support, and an AI companion.
Precision medicine and data
Best fit
Parkinson's programs that want longitudinal patient-generated data, tremor and dyskinesia summaries, medication and symptom tracking, clinician visit preparation, and supervised AI-supported care coaching.
- Primary use case
- FDA-cleared Apple Watch symptom-data collection, Parkinson's symptom and medication tracking, clinician dashboards, trial matching, and StrivePD Guardian AI companion support for between-visit care
- Audience
- Movement disorder specialists, neurologists, Parkinson's programs, value-based neurology teams, clinical trial teams, payors, caregivers, and patients evaluating wearable-supported Parkinson's care workflows
- Risk level
- High
- Pricing signal
- The StrivePD mobile app is described as free for patients; request current Guardian, Guardian Premier, clinician, payor, health-system, coaching, data, and implementation terms.
- Official sources
- 6 official sources
Compare within workflow: Precision medicine and data · comparison shortlist · source index
Regulatory snapshot
| Status | FDA-cleared StrivePD software ecosystem for Parkinson's symptom-data collection through measurements made by Apple Watch; AI companion and service workflows require separate intended-use review. |
|---|---|
| Review route | 510(k) K213519. |
| Intended use | Collects patient symptom data through Apple Watch measurements for Parkinson's disease workflows, supporting care management and clinical-trial data use; it is not a replacement for clinician diagnosis or treatment decisions. |
| Verification note | Confirm the deployed StrivePD version, Apple Watch requirements, enabled measures, patient population, clinician dashboard use, Guardian AI boundaries, labeling, and current FDA database record before go-live. |
| Source | www.accessdata.fda.gov / cdrh_docs / pdf21 |
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Rune Labs StrivePD as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat the Apple Watch symptom-data workflow as FDA-cleared software under the cited 510(k), but review StrivePD Guardian, coaching, clinician dashboards, payor programs, and trial workflows separately for intended use, clinical claims, patient instructions, and local medical-device obligations. |
|---|---|
| Privacy | Verify controller versus processor role, BAA terms, Apple Health and wearable data flows, PHI and consumer-health data handling, research sharing, AI companion transcript retention, coaching access, subprocessors, deletion rights, audit logs, and whether patient-facing privacy terms differ from provider or payor agreements. |
| Evidence | Require evidence for tremor and dyskinesia measurement reliability, clinician-dashboard usefulness, medication and symptom interpretation, Guardian guidance quality, trial-readiness claims, and any outcome or cost claims before using it for care management decisions. |
| Workflow | Best governed as supervised Parkinson's disease management support: clinicians define what data is reviewed, patients know when to seek urgent care, AI guidance stays within safe education and coaching boundaries, and medication or treatment changes remain clinician-owned. |
Where Rune Labs StrivePD fits
Rune Labs describes itself as a precision neurology software and data analytics company focused first on Parkinson's disease. Its StrivePD site describes a free patient app, Apple Watch symptom capture, medication and activity tracking, clinician sharing, trial access, and StrivePD Guardian as an AI companion with unlimited chat, proactive insights, and personalized guidance. FDA K213519 cleared StrivePD to collect Parkinson's symptom data through Apple Watch measurements; that clearance should not be assumed to cover every coaching, payor, trial, or AI companion workflow without intended-use review. Rune's privacy notice says it may act as controller or processor, may process PHI as a HIPAA business associate, and may share information with service providers, researchers, or as legally required.
Not for: Autonomous diagnosis, emergency triage, unsupervised medication changes, use outside Parkinson's workflows, or deployment where patient consent, Apple Watch eligibility, clinician review, and AI companion boundaries are unclear.
What to verify before using Rune Labs StrivePD
- Which workflow is in scope: free patient app, Apple Watch movement-disorder measures, clinician dashboard, StrivePD Guardian AI companion, Guardian Premier human support, payor program, or trial data collection.
- Whether FDA 510(k) clearance applies to the exact software version, Apple Watch data stream, tremor or dyskinesia measure, intended user, and Parkinson's symptom-data workflow being deployed.
- How patient-generated health data, Apple Health data, medication logs, symptom journals, clinician dashboards, AI companion messages, coaching notes, and trial-matching data are collected, shared, retained, corrected, and audited.
- What guardrails prevent the AI companion from giving unsafe medication, diagnosis, emergency, or treatment advice, and how escalation to clinicians or emergency services is presented to patients and caregivers.
- Local validation plan for adherence, clinician workload, report usefulness, false reassurance, equity across disease severity and device access, caregiver burden, and impact on visits, complications, or emergency utilization.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- runelabs.io
- www.strive.group
- www.businesswire.com / news / home
- www.accessdata.fda.gov / cdrh_docs / pdf21
- runelabs.io / privacy-notice
- www.runelabs.io / chd-privacy-notice
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