AI in Medical Imaging Round-up – November 2023

Cranfield, UK, 23rd November 2023, Written by Ellie Baker –

Hello everyone! Looking forward to travelling to Chicago at the end of the week ahead of my first ever #RSNA. I’m sure the next few days will be packed with pre-show product launches and partnerships but in the meantime, here’s my round-up for November so far…

1. Annalise.ai has received 12 US-FDA clearances in 2023 so far, an impressive feat for any vendor. The vendor has now packaged these solutions (5 for chest X-ray and 7 for non-contrast head CT) into a solution tailored for the US market: Annalise Triage. However, with a total of 254 possible findings on offer, Annalise has a long way to go before its Annalise Enterprise CTB and Annalise Enterprise CXR are offered in their entirety. Does the US-FDA need to reconsider its positioning on providing clearance for comprehensive solutions?
2. Lunit Cancer Screening has already made three exciting advancements in November, the first of which being the company’s inclusion in CancerX ’s first official project which aims to enhance equity and reduce financial burden in cancer care. The second was Lunit’s US-FDA 510(k) clearance for Lunit INSIGHT DBT. This will enable Lunit Cancer Screening to target the US market more aggressively where DBT is the preferred breast cancer screening technique. However, the company does face strict competition here, with many breast AI vendors active including Hologic, Inc. and iCAD . And finally, Lunit Cancer Screeninghas raised $150 million in new capital which will go towards product development and overseas subsidiaries.
3. Keeping on trend with Signify Research’s recent Venture Capital Funding analysis which highlighted that medical imaging AI companies are raising larger and later funding rounds, Elucid raked in a huge $80M Series C funding round. Elucid has earned its spot in Signify Research Ltd’s ‘$100M club’ with the company’s total funding now at $121M. The funding raised by cardiology AI vendors, with the likes of Cleerly and HeartFlow, Inc , dwarfs the rest of radiology and the question now remains how do radiology AI vendors mirror this success?
4. I want to point your attention to a paper published in NEJM AI which explores the adoption and usage of medical AI devices in the United States by tracking CPT claims. 16 medical AI procedures are billable under a CPT code, however few devices have gained significant market traction, highlighting that the medical imaging AI market is still in the early stages of development. HeartFlow, Inc , Cleerly and Perspectum Ltd topped the list for the greatest number of claims received. Whilst on the topic of reimbursement, the CMS has published its final clinical APC rule for UltromicsEchoGo solution which sees it assigned to APC 5743 with an RVU of $284.88.
5. Cleerly introduced the TRANSFORM trial which aims to enrol 7,500 patients with pre-diabetes or metabolic syndrome across 100-200 US sites. TRANSFORM is a randomised prospective study which sets it apart from many AI studies which use retrospective data. The study is aiming to evaluate personalised heart disease care, with the hope of proving that a personalised care strategy based on Cleerly’s analysis is better at preventing cardiovascular events than traditional cardiovascular risk factors. The results, expected in 2028, will be eagerly awaited and have the potential to aid the earlier prevention of cardiovascular events.
6. Both PIXYL and RapidAI have gained US-FDA clearance in November. PIXYL obtained FDA clearance for Pixyl.Neuro™, their AI software for brain MRI analysis which aids the identification, early diagnosis, and monitoring of neurological disorders. The question remains, will PIXYL be able to tap into the recent Category 3 CPT code for brain MRI quantitative analysis? RapidAIreceived US-FDA clearance for Rapid SDH which detects and notifies suspected acute and chronic subdural hematoma. With SDH cases expected to rise by nearly 80% by 2024, the solution could provide very useful in combating the increase in expected scans.
7. There has been growing momentum in favour of national population-based CT lung screening programs recently with both the HUNCHEST-II and I-ELCAP studies published which demonstrate the advantages. This is great news for those vendors with AI solutions that aid lung CT exams. One such vendor is Riverain Technologies, who also announced a partnership with 3DR Labs in November. This will provide the more than 200 expert radiologic technologists affiliated with 3DR Labs access to Riverain Technologies ClearRead CT solution.

That’s all for now, but if you happen to be in Chicago next week and want to take the opportunity to connect in person, please drop me a note!

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

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