Reliable Data

Are you measuring at the right moment?

Man taking blood pressure at home

THE PROBLEM: WHEN IS THE RIGHT MOMENT TO MEASURE?

An estimated 1.4 billion adults aged 30-79 years worldwide have hypertension, with 44% unaware of their condition (WHO)[1].

Blood Pressure is intended to be measured when a person is in a relaxed physiological state[2]. The World Health Organization (WHO) Guidelines mandate:

  • Relax & sit with straight back for at least 5 minutes.
  • No talking while relaxing before measurement.
  • Repeated measurements and average the readings.

All in a busy home or 10-15 minute GP consultation?

Clinical Reality 77% of Doctors, 96% of Nurses do not wait and 93% of Patients do not follow the WHO measurement wait time guidelines.[3]

OUR SOLUTION: ASSESS BEFORE YOU MEASURE

By determining the physiological state of a patient, we can drastically optimize the clinical workflow while improving:

Measurement Reliability
Patient Outcomes
Clinical Decisions

Our patent-pending technology (PCT) unlocks huge market potential by assessing physiological state before measurement. Using advanced algorithms and bio-signals (ECG/PPG), our platform identifies the perfect moment to take a reading, delivering a frictionless, world-class user experience.

Clinical Breakthrough Clinical findings suggest ECG interpeak (R-to-R) standard deviation analysis can effectively reduce the 5-minute wait to just 35 seconds.[4]
Advanced ECG bio-signal analysis
Commercial Vision Phases 1 – 3

The Opportunity

Wavescope’s ambition doesn’t stop at blood pressure readiness. It expands into primary healthcare and AI-driven clinical decision support.

PHASE 1 2 – 3 yrs
Blood Pressure Measurement IP Platform
PHASE 2 3 – 5 yrs
Pre Clinic Vital Signs Assessment (PCVSA) in Primary Healthcare[5]
PHASE 3 4 – 6 yrs
Enables Data Business & Decision Support System
Systematic multi-phase progression from vital signs readiness to primary care decision support.
MLR Ref: MLR-WS-REG-2026-V1 Investigational / Pre-Market Strategy

Regulatory & Reimbursement

Target Regulatory Pathway

Target pathway prioritizes US FDA premarket clearance followed by European CE Mark Certification (Class IIa MDR).

Target 510(k) Pathway under 21 CFR 870.1130

Class II predicate pathway (Product Code DXN: Noninvasive blood pressure measurement system). Investigational technology currently in development; not cleared for commercial diagnostic marketing.

Prospective Reimbursement Alignment

Commercial strategy is architected to integrate into established clinical reimbursement frameworks upon regulatory clearance.

Designed for Established CPT & RPM Frameworks

Designed to support clinical workflows under CPT 99473/99474 (self-measured blood pressure setup and monthly analysis) and CPT 99453–99458 (Remote Patient Monitoring). Aims to support provider clinical quality benchmarks including MIPS Quality 236 (Controlling High Blood Pressure).
Full regulatory filing dossiers and commercial health economic models require authorized recipient validation.
Access Regulated Dossier

*Statements describe investigational development targets. Wavescope is not currently cleared by the FDA or CE notified bodies for diagnostic use or commercial billing.

Partners & Consortium

AINM DTIF Consortium & Backers

Supported by €1 million in non-dilutive matched funding from the Irish Government via the Disruptive Technologies Innovation Fund.

The importance of taking patient vital signs in primary healthcare should not be underestimated!

International Guidelines for General Practice Physicians

A Wavescope survey of healthcare professionals in Ireland shows that the number one factor restricting the measurement of vital signs is TIME.

Wavescope Survey 2024

Leadership

Our Team

Headshot of Alan Gormley. Chief Commercial Officer.

Alan Gormley

Chief Commercial Officer

Innovator, influencer, strategist, expert in global standards and product commercialization.

Headshot of Sean McMahon. CEO and Co-Founder.

Sean McMahon

CEO & Co-Founder

MedTech engineer and AI researcher pioneering high-precision bio-signal devices, clinical workflow optimization, and neural network diagnostics to deliver reliable, actionable vital signs data.

Headshot of Dr Jennifer Grant. Chief Medical Officer.

Dr Jennifer Grant

Chief Medical Officer

Qualified Doctor & Pharmacist. Clinical Lead at Beacon Health Check. Over 20 years clinical experience.

Headshot of James Sheil. Head of Design.

James Sheil

Head of Design

20 years experience in Digital Product, Human Factors, Usability, and UX Design.

Advisory Board

Our Advisors

Headshot of Steen Gordon. Commercial Advisor.

Steen Gordon

Commercial Advisor

Expert in strategic growth, partnerships, and commercial development.

Headshot of Peter Corscadden. Advisor.

Peter Corscadden

Strategic Advisor

Executive expert in health technology scale-up and enterprise AI solutions.

What's New

Clinical Evidence & News

Contact

Contact Us

Our Location

Wavescope Ltd, Workhub
51 Bracken Road, D18CV48, Ireland

Send Us a Message

Our clinical and technical team will respond promptly.