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HealthTech draft guidance

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2 Information about the technologies

2.1

This assessment included 4 technologies (EchoConfidence, EchoGo Heart Failure, Ligence Heart and Us2.ai) that use artificial intelligence (AI) software to aid the interpretation and quantification of echocardiography images and automate report generation. All the technologies included in this assessment are designed to aid the operator, not replace them.

Table 1 Features of each technology

Technology (company)

Regulatory

and DTAC status

Intended use

Target population

EchoConfidence

(MyCardium)

Class IIb

DTAC in place

  • detecting and diagnosing heart failure through screening or clinical echocardiograms

  • stratifying heart failure

  • monitoring disease progression and treatment response

Adults with or without underlying cardiac disease

EchoGo Heart Failure

(Ultromics)

Class IIa (expected June 2026)

DTAC not in place

Providing adjunctive information on a cardiovascular condition to detect HFpEF

Adults over 25 years of age having routine functional cardiovascular assessment or with suspected heart failure

Ligence Heart

(Ligence UAB)

Class IIa

DTAC not in place

Detecting, measuring and calculating various specifications of structure and function of the heart

Adults 18 years and over who are not in a life-threatening state of health, time is not critical for medical decisions, and no major therapeutic interventions are needed

US2.ai

(EKO Pte Ltd)

Class IIb

DTAC in place

  • processing, analysing and measuring TTE images, to provide automated estimation of several cardiac structural and functional parameters

  • accelerating and standardising detection of most forms of heart failure, independent of ejection fraction

Adults as decision support for detecting heart failure, pulmonary hypertension, cardiac amyloidosis, hypertrophic cardiomyopathy and valve disease (for example, aortic stenosis and mitral regurgitation)

Abbreviations: DTAC, digital technology assessment criteria; HFpEF, heart failure with preserved ejection fraction; TTE, transthoracic echocardiography.

Sustainability

2.2

For information, Carbon Reduction Plans for UK carbon emissions, or a commitment to reducing greenhouse gas emissions and achieving net zero, are published here for each technology: