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Cranfield, UK, 28th March 2024, Written by Mustafa Hassan –
How is it Spring already? 2024 seems to be flying by! Also flying are the latest ultrasound news stories, which shows no signs of slowing down so far. March was another month of notable partnership and regulatory announcements.
In this monthly news round-up, we offer some of the latest news and developments impacting the Ultrasound market that has caught our attention in the last month.
New Solutions Receive Regulatory Clearance
1. ThinkSono announced it has received CE class IIb approval for its deep vein thrombosis (DVT) solution. The guidance DVT solution aids untrained clinical staff to screen suspected DVT patients for blood clots using ultrasound. This solution decreases patient wait times and enables treatment pathways to be started sooner, reducing the risk of pulmonary embolisms and other DVT-related complications. ThinkSono is available on both the Butterfly Network and Clarius Marketplace. It is in a good position for immediate financial returns, especially once the iOS version of its solution is available.
2. GE HealthCare has launched its latest AI solution, Prostate Volume Assist (PVA). PVA will be available on the bkActiv, bk3000/5000 and bkSpecto and will improve the workflow for the urologist in capturing prostate volume. PVA can also calculate and measure the prostate with one-click. This will be helpful in identifying prostate cancer, where prostate volume is an essential measurement. GE HealthCare is the dominant market leader in the urology market, and this AI solution will help maintain its market lead. It is also the latest AI solution designed to optimise workflow and help ease the burden on healthcare workers, currently one of the biggest factors impacting the whole healthcare market.
3. Butterfly Network, Inc. has also received EU clearancefor its iQ3 device, enabling the company to deliver its new Pulse Wave Doppler and AI-enabled Auto B-line counter features to its European customers. The new functionalities will be commercially available in the second quarter of 2024. All key European markets will have access to these new features as well as other markets that accept the CE mark including Australia and New Zealand. Following a difficult 2023, where the company saw a decline in its device sales, the EU clearance of the iQ3 should help it recover some of the market share it had lost in 2023.
4. Clarius Mobile Health has received Health Canada regulatory approvalfor its PAL HD3 whole body ultrasound scanner with bladder AI, enabling auto measurement of bladder volume providing real-time feedback.
5. Lantheus has announced FDA clearance for their ultrasound contrast agent, DEFINITY for use in paediatric patients. The ultrasound enhancing agent , now indicated for use on paediatric patients, is able to enhance the left ventricular chamber and improve the delineation of the left ventricular endocardial boarder on echocardiograms. The contrast can aid in enhancing suboptimal imaging reducing the need for repeat imaging and the scanning time for paediatric patients.
6. Edgecare has now obtained FDA Clearance for its ultrasound bladder scanner EdgeFlow UH10. The scanner uses high-resolution ultrasound imaging to measure bladder volume non-invasively. EdgeFlow UH10 utilises LiveContour and MaxContour deep-learning AI functionalities. The AI solutions aid in the location and assessment of the bladder enabling clinicians of all levels to easily perform the scan. The portability of the scanner coupled with the AI functionality increases the accessibility of the scanner in non-clinical settings and developing regions.
New Partnerships
7. SmartAlpha announced its partnership with Siemens Healthineers at a signing ceremony at the European Conference for Radiology. The partnership aims to advance AI-powered workflow efficiencies in ultrasound to optimise performance across care settings. SmartAlpha’s application supports the interpretation of ultrasound scans helping to make high-quality care more accessible. With many of the recent ultrasound partnerships and acquisitions between ultrasound OEMs and AI vendors being announced by GE HealthCare and Philips, this relationship further highlights the need for vendors like Siemens Healthineers to keep pace with their rivals. With SmartAlpha’s Anaesthesia AI solution receiving CE (MDR) Mark in 2023, this partnership can lead to immediate revenue returns.
8. Samsung Medison and Bracco announced their Memorandum of Understanding at ECR 2024, to pioneer a new area for diagnostic ultrasound device and contrast agent. The agreement will see the companies combine their research efforts to diversify the use of contrast agents and increase image resolution in different settings and specialties. Bracco Imaging’s quantitative diagnostic analysis software will be integrated with Samsung Medison’s diagnostic ultrasound equipment to enhance image reporting and improve convenience for medical staff. This announcement was closely followed by Boston Imaging – A Subsidiary of Samsung Electronics Co., Ltd. being awarded the HHM Health’s Healthcare Innovator Award. The award was for its SonoSync technology and the companies’ contributions to addressing healthcare disparities in underserved communities. SonoSync enables real-time collaboration between clinicians and experts to improve the quality of patient care in areas that lack access to specialists. Samsung is also developing new AI solutions such as Live BreastAssist, which enables users to track breast lesions in real time, highlighting Samsung as another ultrasound vendor taking a serious approach to the use of AI.
9. Also looking to increase its AI capabilities is EDAN Instruments, Inc., who is collaborating with GH Labs to develop AI-enabled ultrasound devices. Under the agreement, both companies will combine their expertise to create AI-powered ultrasound solutions that enable healthcare providers in low-and middle income countries to identify high-risk pregnancies. This will allow timely interventions to be made, ultimately enhancing prenatal care worldwide. This collaboration is reflective of the growing interest and investment in AI solutions for women’s health and addressing the disparities in pre and postnatal care quality globally. The Bill & Melinda Gates Foundation, who created GH Labs, has been responsible for a significant proportion of the investment, totalling more than $90m since 2022.
Funding
10. March has proved a productive month for ThinkSono. Alongside announcing its CE Mark this month, it has also secured £2.1M in funding. The investment round was led by Id4 Ventures with participation from Brandenburg Kapital, Calm Storm Ventures, Dubai Angel Investors, CrowdCube and Cur8 Capital. This brings its total funding to £5M.
11. Flosonics Medical announced that it had raised $20m USD in Series C funding. The funding was led by New Leaf Venture Partners, with participation from previous investors Arboretum Ventures, Genesys Capital, and iGan Partners. The company, which has developed FloPatch, the first wearable doppler ultrasound system, will use the funding to accelerate its commercial growth, expand indications for use, and continue evidence generation.
Other
12. Also looking to advance its ultrasound wearable technology is Scottish company novosound, who secured a patent for its Slanj digital platform. This wearable, Wi-Fi-enabled ultrasound device uses gel-free sensors to solve issues associated with traditional ultrasound technology. The patent gives Novosound exclusive rights to sell its technology in the United States and the United Kingdom. With the patent, Novosound will hope to license its technology to be integrated into smartwatches to enable 24/7 blood pressure monitoring.
The topic of ultrasound patches has gained traction in the last year, due recent articles highlighting the potential of regular monitoring for various body areas. However, ultrasound patches are still in the academic research stage. The success of products like FloPatch and Slanj, could serve as a blueprint as to how wearable ultrasound devices can best be utilised in the market. This will enable better and more streamlined patient care, as well as reducing the burden on hospitals.
13. MRI/Ultrasound combination imaging has shown effectiveness for the treatment of prostate cancer. The technique involves integrating MRI and transurethral ultrasound ablation. Studies show that this procedure was a viable minimally invasive alternative to surgery or radiation whilst minimizing damage to the surrounding prostate area and maintaining urinary continence. The combination treatment offers a more favorable, less invasive treatment pathway for men with prostate cancer. It is believed it will offer a higher quality of life post disease, with decreased long-term side effects like urinary incontinence and erectile disfunction.
14. GE HealthCare have utilised the AI technology of NVIDIA to aid in the creation of their SonoSAMTrack foundation model. The model is designed to enhance ultrasound image segmentation of anatomies and lesions, to help improve the efficiency and accuracy of imaging systems and increase the quality of patient care. SonoSAMTrack has shown effectiveness in multiple clinical applications including heart, prenatal, women’s health and MSK. However, SonoSAMTrack has yet to receive clinical approval. Whilst it can offer swift adaptation to a variety of medical conditions without extensive training requirements, it is likely to have the same initial user resistance, and regulatory approval hurdles as machine learning AI solutions.
With Easter falling at the end of March, I have uploaded the roundup a few days early. Any news I’ve missed between now and the end of the month I’ll add to the April round up. I hope you all have a wonderful Easter.
Until next time, stay connected.
Are there any stories you believe we have missed? If so, please let us know. We welcome further conversations on the trends specifically impacting the markets highlighted.
Signify Research covers the market dynamics impacting the ultrasound market in its annual Ultrasound Service. The 2024 service will include:
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· Ultrasound Transducers and Catheters
· Ultrasound AI
· Ultrasound Equipment 6 – month update
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Ultrasound Market Intelligence Service – 2024
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About The Authors
Mustafa Hassan – Mustafa joined Signify Research in 2020 as part of the Medical Imaging team which covers areas such as ultrasound, general radiography and machine learning in medical imaging. Prior to that he obtained a PhD in Pharmacy and Physiology from the University of Kent and has three years of post-doctoral experience working on optimising healthcare for genetic Cardiac diseases.
Aiyana Amess – Aiyana joined Signify Research in 2023 as part of the Medical Imaging team. She graduated from Loughborough University with a BSC in Medicinal and Pharmaceutical Chemistry, receiving a diploma in industrial studies after completing an internship at Roche.
About the Medical Imaging Team
Signify Research’s Medical Imaging team formulates expert market intelligence for some of the leading Ultrasound, CT, MRI, and X-ray 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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