2 Information about the technologies

2.1

The technologies included in this early-use assessment apply algorithms (artificial intelligence [AI]-derived or rules-based algorithms) to spirometry to support the diagnosis of lung conditions (see table 1), alongside other clinical factors. They can be used by healthcare professionals in primary care and community diagnostic centres. The technologies provide algorithmic support for spirometry by:

  • quality assessing spirometry performance

  • interpreting spirometry results (for example, recognising whether the spirometry trace is obstructive, restrictive, or otherwise)

  • suggesting a diagnosis based on spirometry results and other clinical factors.

    Technologies included in this guidance may have additional functions or use cases that are outside of the scope of this assessment. The recommendations in this guidance do not apply to the technologies when used to support other aspects of the diagnostic, prognostic or care pathways for asthma and COPD that are out of scope for this assessment.

2.2

All technologies (ArtiQ.Spiro, EasyOne Connect, GoSpiro and LungHealth) are software, but do require spirometry hardware (a spirometer) to obtain spirometry readings. Information on the range of compatible spirometers for each software (at the time of the assessment) is reported in table 2 of the external assessment report. The most up-to-date information on spirometer compatibility may be available on request from manufacturers. Spirometry hardware that is compatible with software for applying algorithms to spirometry is out of scope for this assessment. Additional software that can be integrated with digital technologies for applying algorithms to spirometry to support other aspects of the diagnostic pathway (for example, to enhance data management and workflow) is also out of scope for this assessment. As such, the recommendations in section 1 do not1 apply to the use of spirometer hardware for obtaining spirometry readings, or additional software that can be integrated.

2.3

NuvoAir is no longer available to the NHS, so the committee could not make a recommendation on this technology.

2.4

Information on MIR Spiro was provided to NICE by the technology manufacturer and UK distributor during consultation on the draft guidance. This information was discussed by committee at the second committee meeting. A decision was made by the Committee Chair (following advice from a specialist committee member) that MIR Spiro is not within the scope of this assessment and should be removed from this guidance.

Table 1 Technologies included in the assessment
Technology (company)  CE mark  Population  Type of algorithm  Setting  Component parts 

ArtiQ.Spiro

(Clario)

IIa

5 to 96 years for quality assessment and pattern recognition, 18 years and over for providing a diagnostic suggestion

AI and rules-based (uses ATS and ERS guidelines)

Clinic

Software that is compatible with specified spirometers.

EasyOne Connect (NDD)

IIa

4 years and over

Rules-based (uses ATS and ERS guidelines)

Clinic

Software that is compatible with specified spirometers.

GoSpiro (Monitored Therapeutics)

IIa

5 years and over

AI and rules-based (uses ATS and ERS guidelines)

Clinic

Software that is compatible with specified spirometers.

LungHealth (LungHealth)

I

18 years and over for COPD, 12 years and over for asthma

AI and rules-based (uses BTS, GOLD, NICE and SIGN guidelines)

Clinic

Software that requires input of spirometry results (done using any spirometry hardware).

Abbreviations: AI, artificial intelligence; ATS, American Thoracic Society; BTS, British Thoracic Society; COPD, chronic obstructive pulmonary disease; ERS, European Respiratory Society; GOLD, Global Initiative for Chronic Obstructive Lung Disease; SIGN, Scottish Intercollegiate Guidelines Network.

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