ClearSky Medical Diagnostics

What ClearSky Medical Diagnostics does

ClearSky Medical Diagnostics is a privately-held UK medical device and AI services company founded in 2013 as a university spin-out from collaborations between Leeds General Infirmary, Heriot-Watt University, and the University of York. The company develops CE-marked, non-invasive medical devices—PD-Monitor, LID-Monitor, and MCI-Monitor—that use proprietary white-box evolutionary algorithms to objectively measure motor and cognitive symptoms associated with Parkinson's, Huntington's, and Alzheimer's diseases. Underlying these products is the Neuro-AI platform, a set of biologically-inspired machine learning classifiers that prioritize transparency and efficient handling of limited clinical data.

The company operates four revenue streams: hardware sales of CE-marked devices, clinical research services for pharmaceutical and biotech trial sponsors, custom algorithm development, and end-to-end product development support including hardware sourcing, regulatory documentation, and clinical study design. Customers include NHS hospital trusts, academic medical centres, and pharmaceutical/biotech sponsors conducting neurodegenerative disease trials. Notable engagements include the Exenatide-PD clinical trial (200 participants across 15 UK hospital centres) and the TAP-HD Huntington's disease study (205 participants, partnered with CHDI Foundation).

ClearSky employs 1-10 staff across offices in York, UK and New Zealand, and generates demand primarily through direct enterprise sales, industry conference presence (MDS Congress, EHDN), and clinical research partnerships. Pricing is quote-based and not publicly disclosed. The company holds no disclosed external venture capital or private equity investment, appears founder-controlled under Managing Director Prof. Stephen Smith, and reports no public revenue figures.

Name

ClearSky Medical Diagnostics

Legal name

ClearSky Medical Diagnostics Limited

Website

https://clearskymd.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

1–10 employees

Ownership category

akta.pro rank

Product category

Medical Devices for Neurodegenerative Disease Diagnostics

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Neurological Monitoring (EEG, Seizure/Sleep/Neuro Wearables) (HLAHACAE)

akta.pro secondary industries

SaMD – Imaging & Signal Analysis (AI/ML) (HLACANAG), SaMD – Digital Biomarkers & Algorithmic Endpoints (HLACANAF), Neurology RPM (epilepsy, Parkinson’s, MS monitoring) (HLALAFAJ)

Keywords

• Medical device diagnostics
• Neurodegenerative disease monitoring
• Wearable movement sensors
• Clinical research AI services
• Machine learning healthcare

Headquarters

HQ city

Cottingham

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain, Infrastructure

Revenue model

1. Medical Device Sales: Sale of CE-marked intelligent medical devices (PD-Monitor, LID-Monitor) for clinical diagnostics and monitoring of neurodegenerative conditions.
2. Clinical Research Services: AI/ML services for clinical research including protocol development, data collection, statistical analysis, and machine learning application for pharmaceutical and medical device companies.
3. Algorithm Development Services: Custom algorithm development tailored to customer research needs, covering protocol design, data collection, and machine learning techniques for neurodegenerative disease assessment.
4. Product Development Services: Comprehensive product development support including algorithm development, hardware sourcing/validation, regulatory documentation, and clinical study design and implementation.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels6 records

Core offering

ClearSky develops and sells CE-marked, non-invasive medical devices (PD-Monitor, LID-Monitor, MCI-Monitor) that use proprietary white-box evolutionary algorithms to objectively measure and monitor symptoms of neurodegenerative diseases including Parkinson's, Huntington's, and Alzheimer's. The company also provides AI/ML clinical research services and custom algorithm development to pharmaceutical companies and clinical researchers.

Product overview

ClearSky Medical Diagnostics offers a portfolio of clinically validated intelligent medical devices and AI/ML services for neurodegenerative disease assessment. The core portfolio consists of three CE-marked devices: PD-Monitor (for Parkinson's disease diagnosis via finger tapping analysis), LID-Monitor (for 24-hour levodopa-induced dyskinesia monitoring), and MCI-Monitor (for Mild Cognitive Impairment evaluation via reach-and-grasp tasks and eye saccades). These devices share a common technological foundation—ClearSky's proprietary white-box evolutionary algorithms that process movement data from wearable sensors. The company also provides drawing-based cognitive tests for visuospatial assessment. Complementing the device portfolio, ClearSky offers AI/ML services including clinical research support (protocol development, data collection, statistical analysis, machine learning application) and product development services (algorithm development, hardware sourcing/validation, regulatory documentation, clinical study design). The services leverage the same AI expertise that powers the devices, enabling customized solutions for pharmaceutical companies and clinical researchers.

Differentiator

Problem solved

Functional benefit

Products and services

• PD-Monitor A CE-marked medical device that provides objective measurement of finger tapping in Parkinson's motor examination. Small non-invasive sensors are positioned on the finger and thumb to measure patient movements during the finger-tapping test. Data is analyzed by ClearSky's white-box algorithms to recognize tremor and bradykinesia, key symptoms of Parkinson's disease. The device is intended for clinicians and clinical researchers diagnosing and monitoring Parkinson's disease.
• LID-Monitor A CE-marked wearable medical device providing 24-hour continuous at-home monitoring of levodopa-induced dyskinesia in Parkinson's disease patients. Six wireless sensors are worn around the home to recognize dyskinesia and Parkinson's symptoms, with data transmitted electronically to specialists in an easy-to-interpret graphical format. The device is for clinicians managing Parkinson's patients who require objective, ongoing monitoring between visits.
• MCI-Monitor A novel cognitive assessment device for evaluating Mild Cognitive Impairment (MCI). Patients wear smart glasses and a data glove while performing reach-and-grasp tasks, with data processed by specialized software to provide objective assessment of visuospatial ability, memory, and executive function. The device is intended for clinicians and researchers assessing early cognitive decline related to Alzheimer's and other dementias.
• Drawing-based Cognitive Tests Digitized drawing-based cognitive tests used to grade cognitive functions. ClearSky has developed capabilities to quantify drawing test assessments by sourcing and validating off-the-shelf hardware for pen movement data collection from digitized drawings. Intended for clinicians and researchers evaluating visuospatial ability and cognitive function.
• AI & Machine Learning Healthcare Solutions White-box machine learning solutions using evolutionary algorithms for solving complex medical problems. The approach provides transparent, interpretable AI for medical diagnostics, enabling healthcare professionals to understand how decisions are made. Offered to clinical researchers and healthcare organizations requiring bespoke AI applications.
• Clinical Research Services AI/ML services for clinical research including protocol development, data collection, statistical analysis, and machine learning application for pharmaceutical and medical device companies. The services are targeted at clinical research organizations and pharmaceutical sponsors undertaking neurodegenerative disease studies.
• Algorithm Development Services Custom algorithm development tailored to customer research needs, covering protocol design, data collection, and machine learning techniques for neurodegenerative disease assessment. The offering is for clinical researchers and pharmaceutical companies requiring bespoke analytical models.
• Product Development Services Comprehensive product development support including algorithm development, hardware sourcing and validation, regulatory documentation, and clinical study design and implementation. The service supports medical device and pharmaceutical partners seeking end-to-end development capabilities for neurodegenerative disease solutions.

Quantifiable outcome

• Objective motor assessment for Parkinson's diagnosis using finger tapping analysis
• +3 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability4 records

Feature5 records

Partnerships

Three partnerships are on record, tiered core and minor.

• Shimmer Research (Verisense Sensor Platform)coreTechnology or Integration · 21 June 2019Partnership between ClearSky and Shimmer Research combines the Verisense wearable sensor platform with ClearSky's algorithms and machine learning expertise to provide AI-empowered digital solutions for central nervous system diseases including Parkinson's, epilepsy, and dystonia. Verisense sensors provide continuous raw motion data for sophisticated algorithms while placing minimal burden on participants.
• CHDI FoundationcoreStrategic or Co-development PartnerCollaboration with CHDI Foundation, a privately funded nonprofit biomedical research organization dedicated to developing therapeutics for Huntington's Disease. ClearSky contributed digital tracking technology to the TAP-HD study, using motor and eye movement tracking to capture subtle changes in individuals with Huntington's disease.
• UCL Queen Square Institute of NeurologyminorStrategic or Co-development PartnerChief investigator Dr Thomas Foltynie at UCL Queen Square Institute of Neurology leads the Exenatide-PD clinical trial using ClearSky's PD-Monitor. Trial involves 200 participants from 15 hospital centres across the UK testing exenatide for Parkinson's disease.

Scale indicators6 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• IXICO: UK-based digital health company providing AI-enabled imaging and digital biomarker technologies for neurodegenerative disease clinical trials, with overlapping customer base (global pharma sponsors) and comparable focus on Huntington's, Alzheimer's and Parkinson's disease trials.
• Cumulus Neuroscience: UK-based digital biomarker company developing a multi-domain CNS assessment platform for clinical trials, with overlapping focus on neurodegenerative indications and objective at-home neurological measurement.
• VivoSense: US digital biomarker company developing wearable-derived endpoints for CNS and other clinical trials, including Parkinson's disease programs, directly comparable to ClearSky's clinical research services and digital endpoint offering.
• Empatica: Developer of medical-grade wearables and AI for neurological monitoring (epilepsy, Parkinson's), with FDA-cleared Embrace watch; competes with ClearSky in neuro-wearable monitoring and CNS clinical research partnerships.
• ActiGraph: Leading provider of wearable actigraphy sensors and digital endpoint solutions for pharmaceutical clinical trials, with comparable GTM targeting pharma sponsors and CROs for objective activity and movement data capture.
• Great Lakes NeuroTechnologies: US-based developer of the Kinesia family of wearable sensors and objective measurement tools for Parkinson's disease motor assessment, directly competing with ClearSky's PD-Monitor and LID-Monitor in movement-disorder clinical trials and clinical practice.
• Koneksa Health: Digital health company focused on developing and validating digital biomarkers for use in clinical trials across CNS and other indications, comparable in providing algorithm-backed sensor analytics to pharma sponsors.

Broad incumbents

• Medidata (Dassault Systèmes): Enterprise clinical trial platform with sensor and decentralized trial capabilities acquired via integrations; competes at the platform layer for pharma trial endpoint contracts that ClearSky also targets.
• Signant Health: Large clinical trial technology vendor providing eCOA, ePRO, and digital sensor solutions across therapeutic areas including CNS; broader portfolio but overlaps with ClearSky in objective digital endpoint delivery for pharma trials.

Emerging players

• Biofourmis: Digital therapeutics and remote monitoring platform with wearable biosensors applied to CNS and other therapeutic areas; broader portfolio but overlapping pharma clinical trial endpoint use cases and AI-based analytics.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/clearskymd
• YouTubeyoutube.com/@clearskymedicaldiagnostics9657
• Facebookfacebook.com/clearskymedical
• LinkedInlinkedin.com/company/clearsky-medical-diagnostics

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about ClearSky Medical Diagnostics