Three companies (Gleamer, Milvue and Radiobotics) submitted a request for information (RFI) response to inform this assessment, no RFI was received from AZmed or Qure.ai. As part of the RFI responses, each company provided details about evaluations of their technologies that may be relevant for consideration within this assessment. These studies were screened using the same methods described in the protocol2 for the assessment, meaning that they were included where they met the inclusion criteria for the evidence reviews. This included two unpublished manuscripts, currently in preparation, submitted by Radiobotics. Studies that were excluded during screening are listed in Appendix 3 alongside the reasons for exclusion.
A number of studies described by companies in their RFI responses were identified by the EAG as plausibly relevant but there was insufficient information to determine their eligibility for the assessment. This included studies where:
- It was unclear whether the technology was evaluated as a stand-alone diagnostic tool or whether the technology was used in conjunction with clinician judgement.
- An incomplete citation was provided by the company, and it was not possible to identify the publication source.
- Results were not provided for any of the outcomes in the NICE scope,1 or data were presented in an unusable format.
In all such cases, the EAG submitted a request for clarification from the companies who submitted RFIs (Gleamer, Milvue, and Radiobotics).
Similar uncertainties were identified for several studies identified by the EAG in its evidence review, in addition to uncertainties regarding the name of the technology evaluated. Requests for clarification were submitted to companies where they were listed as a study sponsor and/or where staff from the company were listed as a study sponsor (Gleamer, Milvue, AZmed, and Radiobotics).
Where no clarification response was received by the companies, any studies that did not clearly meet the review eligibility criteria, as outlined above, were excluded.