Clinical-Grade Cardiac Monitoring in Your Pocket
CardioCareAI provides clinical-grade cardiac monitoring (97% accuracy) accessible via smartphones, bridging the gap between expensive clinical Holter monitors and inaccurate consumer wearables.
The Cardiac Detection Gap
Millions with intermittent arrhythmias go undetected because current options force a choice between clinical accuracy and accessibility.
Clinical Holter Monitors
- £500–2,000+ per session
- 24–48 hours only
- Days to weeks for results
- Requires specialist referral
Consumer Wearables
- 60–80% accuracy (not clinical-grade)
- AFib only — miss other arrhythmias
- Basic metrics, not clinician-ready
- Limited clinical validation
The Human Cost
- 39,000 premature CVD deaths in England (2022)
- 7.6 million UK residents with heart disease
- 18-week+ average wait for cardiac care
- 75% increase in cardiac waiting list since 2020
Bridging the Gap with AI
CardioCareAI delivers clinical-grade cardiac monitoring accessible from any smartphone — matching Holter monitor accuracy at a fraction of the cost.
- 97% sensitivity deep learning model for 12-lead ECG interpretation
- 15 arrhythmia categories detected (AFib, PVC, PAC, tachycardia, bradycardia, SVT, AV block, bigeminy, trigeminy, and more)
- Dual signal analysis: ECG + PPG simultaneously (industry first)
- Sub-second processing latency — results in under one second
- AI-powered natural language clinical summaries
- FHIR-compliant reporting for NHS/EHR integration
- Multi-platform: Web, iOS, Android, WatchOS, WearOS
Why We Win
Six defensible moats that make CardioCareAI the category leader in UK AI cardiac monitoring.
NHS-First Strategy
Only AI cardiac platform with active NHS Trust pilot deployments. Direct relationships with UK healthcare system create an unmatched distribution advantage.
Dual Signal Analysis
First platform to analyse ECG + PPG simultaneously using AI. More comprehensive cardiac picture through proprietary combined analysis algorithms.
UK-Based Operations
Local MHRA regulatory expertise, aligned time zones, and deep understanding of NHS procurement. A defensible position versus US-based competitors.
Clinical + Consumer
Hospital-grade accuracy (97%) with smartphone accessibility. Affordable subscription pricing with consumer-friendly UX that clinicians also trust.
LLM-Enhanced Reports
AI-generated natural language clinical summaries — patient-friendly AND clinician-ready. Customisable report formats for every stakeholder.
Full Platform Coverage
Web + iOS + Android + WatchOS + WearOS. Complete user journey capture with cross-platform data sync — no competitor matches this breadth.
A £1.66 Billion Market Growing 13% Annually
The UK wearable cardiac devices market is projected to reach £5.66 billion by 2034, driven by NHS digital mandates, post-COVID health awareness, and regulatory tailwinds.
Why Now
- NHS Long Term Plan prioritises digital health; Government Elective Reform Plan (January 2025) mandates shift from hospital to community care
- MHRA AI Airlock sandbox programme launched (April 2024); international reliance pathways accelerate approval
- Deep learning now achieves clinical-grade accuracy; smartphones carry high-quality PPG sensors
- Consumer health monitoring demand at 10-year high; remote patient monitoring is mainstream post-COVID
What We Have Built
The hard technical work is done. We are in execution mode.
Revenue status: Pre-revenue — pilot partnerships with nominal fees. Seed round active.
Three Revenue Engines
SaaS recurring revenue with 80%+ gross margins across consumer subscriptions, NHS enterprise contracts, and white-label partnerships.
Consumer Subscriptions
- Free: £0/month — 5 analyses, basic features
- Pro: £14.99/month — 100 analyses, full features
- Enterprise: £99/month — unlimited, SLA, dedicated support
Target LTV:CAC ratio > 4:1
NHS & Healthcare
- NHS Trust: £10,000–50,000/Trust/year
- Private Clinic: £5,000–20,000/clinic/year
- API Access: £0.50–2.00 per analysis
70–80% gross margin per contract
White-Label & Research
- White-Label: Custom licensing + revenue share
- Targets: Insurance companies, employer health programs
- Academic: Discounted or grant-funded access
Scaled SaaS + API licensing
Built for Clinical-Grade Performance
A modern, scalable stack purpose-built for medical AI — from signal ingestion to clinician-ready reports.
Tech Stack
ML Pipeline
- Signal Ingestion — CSV, EDF, WFDB, RAW, JSON formats supported
- Preprocessing — Bandpass filtering (0.5–45 Hz), baseline wander removal, noise reduction
- Feature Extraction — R-peak detection, RR intervals, HRV metrics (SDNN, RMSSD, pNN50)
- ML Inference — ONNX Runtime, batch processing, optional GPU acceleration
- Post-Processing — Confidence calibration, episode segmentation, severity assignment
- AI Summaries — Natural language clinical reports via Claude API
Clear Regulatory Pathway
A phased regulatory approach targeting MHRA Class IIa clearance, then international expansion through reliance pathways.
MHRA Timeline
ISO 13485-aligned QMS & Design History File
Risk Management (ISO 14971)
MHRA Pre-Submission Meeting
Technical file completion
Class IIa submission
MHRA clearance (targeted)
Positioning Language
Approved Claims
- "Clinical-grade accuracy"
- "Detects potential arrhythmias"
- "Supports healthcare provider decision-making"
- "AI-powered cardiac analysis"
Claims to Avoid (Until Clearance)
- "Diagnoses heart conditions" — use "detects"
- "FDA approved/cleared" — not yet achieved
- "Replaces doctor consultation"
- Specific treatment recommendations
Four-Phase Strategic Roadmap
From foundation to international scale — a clear, milestone-driven path to market leadership.
Foundation & Early Validation
In Progress- 97% sensitivity across 15 arrhythmia categories
- ISO 13485-aligned QMS complete
- 3 NHS Trust pilots active
- Seed round: £250K–£500K
Clinical Validation & Regulatory
H2 2026- MHRA pre-submission meeting (Q3 2026)
- 500+ patient clinical validation study
- MHRA Class IIa submission (Q4 2026)
- Expand to 10+ NHS Trust partnerships
NHS Rollout & Commercial Scale
2027- MHRA Class IIa clearance (Q1–Q2 2027)
- NICE health technology assessment
- NHS framework agreement & procurement
- Consumer subscription launch
Scale & International Expansion
2028+- 50+ NHS Trusts, 50,000+ consumers
- FDA 510(k) & CE MDR pathways
- White-label partnerships (insurers, employers)
- Series A or strategic exit
Risks & Mitigation
We take a proactive approach to risk. Every identified risk has a clear mitigation strategy.
Regulatory Risk
MHRA clearance delays or rejection.
Mitigation: Early MHRA engagement via pre-submission meeting. ISO 13485-aligned QMS already complete. Experienced regulatory consultants engaged. Clear Class IIa pathway established.
Clinical Validation Risk
Clinical studies fail to replicate lab accuracy.
Mitigation: NHS pilot data already showing strong results. Multiple validation datasets used. Continuous model refinement capability. Conservative accuracy claims throughout.
Market Adoption Risk
NHS procurement slower than expected.
Mitigation: Dual B2B + B2C strategy. Private healthcare as parallel channel. Freemium consumer funnel reduces CAC. Multiple NHS pilots de-risk adoption.
Competition Risk
Well-funded competitors enter UK market.
Mitigation: NHS-first strategy creates local advantage. 3 NHS Trust pilots establish relationships. UK regulatory expertise is a barrier to entry. Dual signal analysis is a technical differentiator.
Technical Risk
AI model degradation or security breach.
Mitigation: Continuous model monitoring. HIPAA-compliant architecture. SOC 2 Type II planned. Regular security audits and penetration testing.
Funding Risk
Unable to close seed round on target timeline.
Mitigation: Multiple investor conversations active. Bootstrap capability for 6+ months. Grant funding applications submitted. Flexible round size (£250K–£500K).
Seed Round: £250K–£500K
Fuel for the next 18 months — from clinical validation to commercial NHS contracts.
Use of Funds
Clinical study execution, MHRA submission prep, regulatory consultants, QMS maintenance
ML model refinement, platform scaling, security hardening, new feature development
Sales team hire, NHS relationship building, marketing materials, conference presence
Infrastructure costs, legal & accounting, insurance, buffer
18-Month Milestones
Commercial launch (1st May 2026), MHRA Class IIa submission, 10+ NHS Trust pilot partnerships
Clinical validation study enrolment complete, first paying NHS pilot contracts
500+ patient clinical validation complete, consumer subscription launch
MHRA clearance (targeted), £250K+ ARR
First commercial NHS Trust contracts, £500K+ ARR milestone, 25+ NHS Trust partnerships
The People Behind CardioCareAI
A lean team with deep technical expertise and direct NHS relationships.
Dr Mahdi Torabi
Director / Team Lead and Signal ProcessingMahdi, as a Team leader and Project manager, covers the development of Signal & Image processing, Computer Vision, plus AI (Machine learning & Deep learning) for the project.
Saman Salari
Product Designer & Web DeveloperSaman earned his Master’s degree in Computer Science from the University of Hull in 2023 and is with us as a designer, developer, and technical member of the project.
Dr. Yashar Shokouhi
Academic R&DYashar’s research explores AI, data science, advanced signal processing, and complex system modeling in neuroscience, biomedical applications, and healthcare, covering the academic R&D of the project.