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Cranfield, UK, 4th September 2024, Written by Amy Thompson –
Firstly, I’m excited to share that Felix Beacher, PhD has joined Signify Research Ltd this month and will be working with myself on our AI coverage. Any questions on the below, or if we have missed any announced, please reach out to Felix or I.
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Another busy month in the Medical Imaging AI market! I’ve shared a summary of news that has caught my attention this month.
Reimbursement
Let’s start off with the latest in reimbursement, Annalise.ai announced that it has secured a Medicare New Technology Add-on Payment (NTAP). CMS has granted the NTAP for the use of Annalise – Obstructive Hydrocephalus, part of the Annalise Critical Care AI Solution, to triage non-contrast brain CT scans suspected of obstructive hydrocephalus (OH). A significant milestone for AI vendors, and one that signals Annalise’s strategy to mitigate the challenges of the US regulatory market. Although the vendors comprehensive solution is yet to receive full approval, this is a noteworthy announcement and one that will offer a commercial driver whilst regulatory progress continues.
Acquisition & Partnerships
Although technically a September announcement, I didn’t want to miss the opportunity to include the latest acquisition to hit the ultrasound AI market, with Samsung Medison acquiring Sonio. Following the completion of the transaction, Sonio will remain an independent company headquartered in France and will continue its commercial growth independently. Unsurprisingly, the flurry of acquisition remains with the modality vendors seeking solution that optimise devices and the pre-acquisition workflow. Despite the impending consolidation in the AI market (ISV and platform), the acquirers are expected to remain larger AI and platform vendors, alongside device / modality vendors, as opposed to PACS vendors…for now.
In addition to the acquisition, August observed a number of partnerships. Partnerships that can be categorised into 2 groups.
(1) Expansion of AI platforms with new AI ISV partnerships.
For example, CARPL – Radiology AI Platform announced a partnership with CASIS – CArdiac Simulation & Imaging Software to offer it’s QIR Suite on the CAPRL platform. Additionally, Blackford made two announcements this month, firstly Imbio, to integrate Imbio’s Lung Density Analysis and RV/LV Analysis software, and secondly, CureMetrix and the integration of it’s cmAngio solution.
Us2.ai will collaborate with M3 and Japanese hospital, Juntendo University, to drive market development for Us2.ai in Japan. M3AI is an AI platform vendor in Japan, formed through a joint vendor with PSP Corporation, a Japanese PACS vendor.
(2) AI platform partnerships with imaging IT vendors.
Ferrum Health, Inc. announced a strategic partnership with PaxeraHealth. Although this is not the first integration Ferrum has completed with an Imaging IT vendor, with the vendor touting the ability to integrate with several PACS and RIS vendors. This is however, one of the first strategic partnerships where alliances have been more closely drawn. Paxera can prove a good choice if Ferrum is evaluating new markets such as the Middle East and Africa, however in the domestic US market, Paxera is yet to hold a leading position in radiology IT. Strengths for the vendor, and a synergy between the two vendors is in outpatient and teleradiology market – whereby a complementary fit is expected.
Following the partnership with CASIS, CARPL – Radiology AI Platform also announced a partnership with United Imaging Intelligence. This is an interesting partnership, as United Imaging has a wide range of post-processing capability, although primarily a hardware vendor with an aggressive strategy to expand beyond the Asia Pacific market. The integration includes uAI Discover solutions for CCTA, Pulmonary Nodules and Bony Thorax Fractures. For CARPL, this creates an opportunity to explore an alternative sales channel with a predominantly advanced visualisation vendor, as opposed to the traditional PACS partners previously announced.
Funding Announcements
Sadly, the spike in funding announcements witnessed in July, was not replicated in August, with no VC-led funding announcements. However, Cortechs.ai did announce that it received a 3-year multi-million dollar NIH grant. The grant has been awarded to support the development of additional analysis software to automatically detect and quantify the Amyloid Related Imaging Abnormalities (ARIA) throughout the treatment of Alzheimer’s patients to monitor the effects of the therapeutic intervention and to improve patient management.
Regulatory Approvals
August was a big month of approvals, starting with the list of approvals the FDA published, which outlined the 950 AI/ML devices that have been authorised since it began keeping track. The FDA has maintained double-digit growth of AI authorizations for the last several years – evidence of the opportunity the US market offers for AI, but also the increased competition observed in the market. Although many AI vendors are targeting the US market –
For vendor announcements this month, let’s start with AIRS Medical, building from the funding round confirmed in July, the vendor secured Health Canada approval for SwiftMR. SwiftMR, is a vendor neutral application for MRI scan reconstruction.
Nanox AI received FDA Clearance for HealthCCSng V2.0, an upgraded version of Nanox.AI’s cardiac solution, HealthCCSng, which identifies patients at high risk of coronary artery disease. The update introduces new features, such as, Zero coronary artery calcium (CAC) Category, Numerical CAC Scoring and CAC Category Configuration.
Qure.ai announced 510(k) FDA clearance for its new solution, qCT LN Quant. The solution supports radiologists and pulmonologists in analysing lung nodules on non-contrast chest CT scans and tracking volumetric growth as part of progression monitoring. The vendor has also reported that the qCT LN Quant solution is potentially eligible under two CPT codes for reimbursement – tissue quantification CPT 0722T for CT and 3D reconstruction code.
The latest version of CoLumbo AI Spine Assistant has secured FDA 510(k) clearance. Version 3 now supports DICOM images for patients with scoliosis and fractures, providing further assistance in measuring and reporting spinal conditions.
Lung Screening in Austria
Austria is the latest country to assess the opportunity and demand for Lung Screening initiatives, with a study published by Berge et. al in July evaluated the cost-effectiveness of a Lung Cancer Screening programme. The evidence of the model demonstrated the effectiveness of a screening programme alongside the need, with lung cancer representing 11% of all newly diagnosed cancers in Austria. Although this does not signal formal steps from the government, it’s a solid first step in identifying the need and the feasibility in creating such an initiative.
That’s all for this month but do subscribe to receive regular updates!
If you have any questions, or would like to delve further into any of the announcements discussed above, please don’t hesitate to drop me a message!
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 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
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