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Cranfield, UK, 8th October 2024 – Co written with Dr Felix Beacher, PhD – It’s that time of the month again, where Felix and I are excited to share the highlights from a very busy September month! Any questions on the below, or if we have missed any announced, please reach out.
Funding
It’s been a busy month of VC funding announcements in the world of medical imaging AI, after a slow 1H, Q3 has certainly ramped up, both in terms of the volume of deals, and the amounts raised.
Qure.ai completed a $65 million Series D funding round. The latest round brings Qure into the esteemed $100m funding club, with the vendor raising over $125m to date. The investment is intended to support the vendors expansion into the US and other markets, enhancing AI model development, and enabling acquisitions in the field.
CEREBRIU raised €17.4M in a Series A funding round, which will enable the company to expand internationally, and further develop its AI tools for MRI diagnostics. Echo IQ (ASX:EIQ) also secured $7.1 million through a share placement to institutional investments. The funds will advance the development of Echo IQ’s cardiac tools and support FDA applications.
Moving beyond image analysis, Ferrum Health, Inc., raised $16 million in a Series A funding round led by Foundry, bringing its total funding to $31 million. These funds will be used to enhance product development and expand partnerships.
Lastly and by no means least, Segmed, Inc., a vendor that offers a iRWD solution for AI development and clinical research, completed a $10.4 million Series A funding round. The opportunity of de-identified and curated imaging data to support RWD has increased rapidly this year, with technology vendors and the lifescience sector recognising the value of data.
Partnerships
In the realm of AI platforms, a couple of partnerships were announced in September. Firstly, Blackford has added Coreline Soft to its platform, making Coreline’s AVIEW solution available to its customers.
Secondly, was the coming together of Viz.ai and Cleerly. Bringing Cleerly’s CCTA solutions into the Viz.ai One platform. This partnership expands Viz’s cardiac AI portfolio, with existing solutions for ECG AI, echo AI and chest CT. Does this partnership signal a strategic move from the vendors to more aggressively take on HeartFlow?
Milvue announced two partnerships in September. Firstly with Olea Medical – Improved Diagnosis for Life , part of Canon Medical Informatics. This is an interesting partnership as it begins to bridge the gap between advanced visualisation and AI ISV competitive ecosystem. This collaboration complements the breadth and scalability of the Olea portfolio, with the depth of Milvue’s AI tools. The second announcement, sneaking it on the last day of the month, was Milvue’s partnerships with Coreline Soft. “TechCare Chest” is a commercial offering that combines Milvue’s emergency chest x-ray solution, with the AVIEW LCS Plus.
Generative AI Evolution in Clinical AI
Two big announcements were made involving generative AI this month; firstly Harrison.ai revealed the concept of “Harrison.rad.1” a foundation model that intends to support in capabilities such as detection, generating structured reports, and the ability for radiologist to participate in open-ended chat to investigate findings for example. This is not a commercialised product, but is intended to demonstrate the potential of foundation models in radiology. The long-term ambition of the solution would be to move towards autonomous reporting – once regulatory challenges and market readiness improves.
Secondly, RadNet’s DeepHealth and HOPPR announced a partnership. The collaboration will commercialise a medical-grade generalised foundation model and foster the development of fine-tuned models for breast, prostate and lung cancer detection. Through the utilisation of the foundation model, product development can be faster and more efficient – which poses interesting questions for the competitive market of clinical AI. For those that leverage such strategies, the ability to bolster new clinical capability quicker, and the opportunity to offer solutions at a competitive price-point due to reduced R&D costs, could cause disruption to the market standing mid-term. Any foundation model will not be the answer however, with AI vendors needing to evaluate the quality of the data and any risks associated to biases or hallucinations.
Pre-Determined Change Control Plans: Regulatory Approval Process
One of the most fundamental problems in the development of medical AI systems is that the pace of technical progress far outstrips the ability of regulators to keep up. To address this, the FDA, along with Health Canada and the UK’s MHRA, have been exploring so-called Pre-determined Change Control Plans (PCCPs). The idea is to facilitate regular updates to software-based medical devices without requiring new regulatory submissions. A PCCP is a structured plan that manufacturers create to manage changes to its devices, ensuring these changes do not significantly deviate from the approved intended use. This plan would be submitted for regulatory review and used for updates. This initiative would significantly reduce the regulatory burden on medical AI developers and could address one of the many barriers facing the clinical (and generative) AI market.
Regulatory Approvals
This month has witnessed several approvals announced. Let’s start with Aidoc , the vendor introduced seven new CE-marked AI tools to the European market. These include tools for detecting urgent pathologies like vessel occlusion and aortic dissection, as well as quantification tools for cardiovascular and neurological conditions. Aidoc now has 26 AI solutions approved in Europe.
Other approvals included:
- Elucid announced its FDA 510(k) clearance yesterday, for its PlaqueIQ. Elucid is currently performing beta testing on PlaqueIQ and anticipates making the software available for limited release later in Q4 2024.
- AZmed received FDA 510(k) clearance for its solution ‘Rayvolve’, which detects fractures on paediatric X-rays. This approval comes two years after gaining clearance for adult fracture detection.
- See-Mode Technologies received 510(k) clearance from the FDA for its thyroid ultrasound analysis and reporting software. This automatically detects and classifies thyroid nodules, according to a standard rating system. The software generates a report and preliminary impressions for clinician review.
- Smart Soft Healthcare software has announced CE mark certification for CoLumbo, the tool supports detection of abnormalities on lumbar MRI scans.
- Avicenna.AI received 510(k) clearance from the FDA for its CINA-CSpine tool, which aids in the detection and triaging of cervical spine fractures from CT scans.
Advancements in Alzheimer related AI tools
icometrix announced the CE mark approval of icobrain aria, an AI-based solution for monitoring Amyloid-Related Imaging Abnormalities (ARIA). This is a significant development in Neurology, namely due to the emergence of amyloid-targeting therapies (such as Aducanumab). icobrain aria automates the detection and severity scoring of these so that amyloid-targeting therapies can be administered more safely. icobrain aria has now gained market approval in Europe, Israel, Japan, Switzerland, and the United Kingdom.
Similarly, Cortechs.ai announced FDA 510(k) clearance for its NeuroQuant 5.0 software. The updates include the improved segmentation for ARIA in patients undergoing anti-amyloid treatment for Alzheimer’s Disease. This builds from the vendors 3-year multi-million dollar NIH grant announcement last month.
Darmiyan launched its BrainSee Platform, integrating the FDA-approved BrainSee Test for Alzheimer’s disease. The Brainsee Test uses data from brain MRIs and cognitive tests to yield a risk score for progression to Alzheimer’s disease within five years. The outcome of such tests could potentially guide early treatment and lifestyle changes. This is a significant step that could have huge societal impact of this disease.
That’s it for this month but do subscribe to receive regular updates.
If you have any questions on any of the announcements discussed above or would like to learn more about Signify Research’s AI coverage, please feel free to get in touch.
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About Amy Thompson
Amy joined Signify Research in 2020, starting as an Analyst in the Imaging IT market, and since progressing to become Research Manager. In Amy’s role, she manages the Imaging IT, AI in Medical Imaging and Teleradiology research portfolio. She brings over eight years of experience as an Analyst in the healthcare sector.
About Dr Felix Beacher, PhD
Felix joined the Signify Team in 2024 as part of our AI in Healthcare department. Felix has a PhD in brain-based diagnostics from the Institute of Psychiatry, London. He led breakthrough research in AI for clinical trials and drug development. He also founded ‘The Medical AI Podcast’.
About the Medical Imaging / Healthcare IT Team
Signify Research’s imaging IT service provides expert market intelligence and detailed insights across radiology IT, cardiology IT, and advanced visualisation IT, alongside operational workflow & business intelligence tools. 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.
About Signify Research
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, Healthcare IT and AI in Medical Imaging.
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