AI in Medical Imaging Round-Up – October 2023

Publication Date: 06/11/2023

Written by

Ellie Baker

Cranfield, UK, 6th November 2023, Written by Ellie Baker –

Hello! I am following in the footsteps of several of my Signify Research colleagues in providing a monthly round-up of exciting news and developments impacting the medical imaging AI market. Here are some of the headlines from last month:

NICE published their guidelines on the use of AI to analyse chest X-rays for suspected lung cancer in primary care referrals. In this particular setting, NICE did not find substantial evidence for the clinical effectiveness and cost impact of AI. The guidance stated that AI should not currently be used to inform clinical care in England’s NHS and instead only be used in research to resolve some of the uncertainty. NICE are open to allow re-assessment in the future when further data is available. Prior to this assessment by NICE, a study published in Radiology highlighted that four commercially available chest X-Ray solutions were found to produce more false-positive findings than radiology reports. The performance of the algorithms also decreased for smaller-sized target findings and when multiple findings were present. Overall, these findings highlight a need for more comprehensive clinical trials when testing AI. Conducting prospective rather than retrospective studies, including the correct patient populations and ensuring AI algorithms are trained on more complex images are steps vendors can take to ensure guidelines do not hinder the success and adoption of AI in the clinic.
VUNO Inc. recieved its first US-FDA 510(k) clearance. It was awarded for VUNO Med-DeepBrain which segments the brain into more than 100 parts and provides quantitative volumetric information along with normative percentiles by quantifying atrophy. This clearance will allow VUNO to target the US market, potentially tapping into reimbursement initiatives such as the Category III CPT code for AI-related brain MRI quantification software.
The US-FDA publisheda list of regulatory approved AI/ML-enabled medical devices which highlighted two key findings. The first was the dominance radiology AI has, with 79% of approved applications being within this area. The second was the projected 30% growth of AI/ML-enabled devices receiving approval in 2023 compared to 2022. This points towards increasing maturity of the medical imaging AI market as an increasing number of AI algorithms become commercially available in the US.
In the world of AI platforms, Blackford Analysis and Enlitic announced a strategic commerical partnership to integrate Enltic’s ENDEX technology within the platform. This will promote data standardisation of medical imaging data, improving operational efficiency and addressing one of the key issues AI aims to tackle: saving time for radiologists. TeraRecon, Inc.also increased its offerings to include a cardiology suite, highlighting that AI platform vendors are maturing in this market.
CureMetrix recieved US-FDA 510(k) clearance for its cmAngio solution. The algorithm analyses FFDM and DBT mammograms to identify women who have breast arterial calcification (BAC), which has been associated with a range of conditions, including coronary artery disease, strokes, hypertension, chronic kidney disease. Volpara Healthhad previously been awarded a US patent for a BAC algorithm, outlining that competition in this market may just be round the corner.
Both Unilab, Inc. and @Humanbytes entered into strategic partnerships with Annalise.ai in October. Unilabs provides Annalise.ai with access to its teleradiology services in acute and trauma care whilst HumanBytes expands Annalise.ai‘s geographical reach to the Nordics. Are there more partnerships to come? With Annalise.ai‘s increasing number of US-FDA approvals it would be wise to watch this space.
Quibim entered a non-exclusive partnership with Philipswhich will see Philips integrate Quibim’s QP prostate solution into MR prostate exams. With evidence mounting in favour of using MR scans over PSA tests to aid the diagnosis and personalised treatment of prostate cancer, this was a necessary step for Philips. Quibim will benefit from the increased deployment of their solution as well as the possibility to integrate additional solutions directly into Philips’ MRI machines in the future.
Signify Research Ltd‘s recent VC funding analysis also highlighted some key insights. The amount of funding raised over the first three quarters of 2023 is at its lowest level since 2019 and there has also been a comparably lower deal volume in the first three quarters of 2023 compared to the same period in 2022 (24 vs 40 respectively). What does this mean for those vendors whose funding runways are running out?

The list could go on… Several other regulatory clearances were granted including DeepTek‘s US-FDA for CXR Analyzer and Lucida Medical LtdClass IIb CE Mark for its Pi solution. The general conversation around AI caught more attention as the AI Safety Summit, which was hosted less than half an hour away from Signify Research’s office, saw the likes of Rishi Sunak and Elon Musk wade in on the conversation.

Anything I’ve missed, feel free to comment below. I’ll be visiting RSNA at the end of the month and look forward to hearing of the new product developments and market trends at the conference. If you would like to arrange a meeting, please get in touch.

About The Author

Ellie joined Signify Research in 2023 as part of the Medical Imaging team. She holds a BSc in Biomedical Sciences from the University of Bath and an MSc in Clinical Drug Development from University College London.

About the AI in Healthcare Team

Signify Research’s AI in Medical Imaging service provides expert market intelligence and detailed insights for several of the leading AI and Imaging IT vendors. Combining primary data collection and in-depth discussions with industry stakeholders, our thorough research approach yields credible quantitative and qualitative analysis, helping our customers make critical business decisions with confidence. Furthermore, our commitment to seeking a plurality of perspectives across the markets we cover guarantees that our insights remain independent and balanced.

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Signify Research provides healthtech market intelligence powered by data that you can trust. We blend insights collected from in-depth interviews with technology vendors and healthcare professionals with sales data reported to us by leading vendors to provide a complete and balanced view of the market trends. Our coverage areas are Medical Imaging, Clinical Care, Digital Health, Diagnostic and Lifesciences and Healthcare IT.

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