Ultrasound News Round Up - October

As October is ultrasound awareness month, it’s a great opportunity to recognise the essential role of ultrasound in healthcare. Once primarily limited to obstetrics and abdominal imaging, ultrasound now plays a key role across all clinical areas. Innovations like 3D and 4D ultrasound, elastography, and contrast-enhanced ultrasound have expanded ultrasound’s capabilities across healthcare, as has the development of handheld ultrasound devices, bringing high-quality imaging to remote and underserved areas.

 The growth of the Ultrasound market will be driven by the rising demand for non-invasive diagnostic methods, improvements in AI integration, and the expansion of portable and wearable ultrasound devices.

 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 Launches

1.     GE HealthCare launched its new Versana Premier AI enabled ultrasound system for primary care. The system promotes improved workflow and enhances clinical efficiency through a variety of AI features including Whizz for image enhancement and Whizz RenderLive and V-Line 2.0 for to capture 3D/4D images to track foetal development. The system was launched a month after the company released its new POCUS system Venue Sprint. Both of the recent releases demonstrate the demand for versatile multi-application systems and the growing demand for imaging in the primary care space to help combat the scanning backlogs in hospitals. GE HealthCare has been utilising AI features to enable easy and faster scanning to save time and enable clinicians with different experience levels to conduct efficient and accurate scanning.

 2.     MicroPort MicroImaging, a subsidiary of MicroPort Scientific Corporation, has received NMPA approval for its Decypher IVUS system and Outsight disposable IVUS diagnostic catheter. The Decypher™ system has a pullback speed of 40mm/s, enabling rapid imaging of coronary vessels and providing detailed images with 20μm resolution. It also includes an integrated controller, which will simplify catheter handling and reduces the need for disposable parts, making it more sustainable. The main use of IVUS catheters are in percutaneous coronary interventions (PCI’s). The use of IVUS catheters in PCI’s is currently below 30% and is expected to increase in the coming years. Whilst Boston Scientific currently dominate the China market with over 50% market share, more local vendors are expected to continue to enter the market. Alongside the Decypher system from MicroPort MicroImaging, SonoScape Medical also introduced its own IVUS system in 2023.

 3.     Novosound has developed a wearable ultrasound device to support remote blood pressure monitoring. The Scottish technology company has created a technology that is wearable within a smartwatch or ring and delivers accurate results comparable with the current standard of devices. The company leverage the pre-existing Slanj platform that has a broad range of health and wellness tracking features. Slowly but surely the ultrasound market is moving towards wearable devices for tracking and monitoring, but with development and research limited to the in the academic space. There are a variety of applications being review for wearable devices including breast screening, but cardiac functionality monitoring appears to be the most appropriate. This is due to the high rates of cardiovascular diseases globally and the 24/7-time frame of monitoring compared to other application areas where only a few hours/days are necessary.

 Approvals

 4.     Ventripoint Diagnostic received CE certification for its VMS+ 4.0 cardiac ultrasound AI solution. The software solution automates the image processing of the ultrasound scanning process, cutting down the time clinicians spend on manual workflow tasks. VMS+ 4.0 received its medical device license in Canada earlier this year and is currently under review by the FDA. Ventipoint plans to market VMS+ 4.0 as a premium product to compliment the V3.2. A common barrier Independent Software Vendors (ISVs) face in the medical imaging AI space is users not seeing the value of AI solutions at higher price points. By Ventripoint marketing the solution as a more premium product with a higher pricing point, it could create a slower uptake from the users with many just opting for the base V3.2 product only.

 5.     iCardio.ai has received FDA 510(k) clearance for its echocardiography AI solution, the approval is for the company’s first foundation model system that interprets echo exams and gives feedback to provide diagnostic guidance to clinicians. The software auto-measures several parameters including Ventricular diameter, interventricular septum and posterior wall, as well as being able to calculate multiple variables like wall dimensions, at systolic and diastolic. iCardio.ai has made a variety of commercial partnerships in different spaces including featuring on AI marketplaces and developing relationships with PACs vendors over the last few years. It also recently joined the Ceder Sanai Accelerator. These developments will act as a launching pad for its break into the market. The diversification of access points will allow for versatility when integrating with hospital IT infrastructure minimising some of the barriers to adoption.

 6.     Arrayus Technologies received Health Canada approval for its MRI-guided focused ultrasound therapy system. Its system is designed to non-invasively treat uterine fibroids and is the first to feature a fully phased array. This will allow for high-precision, real-time monitoring, enabling clinicians to target and ablate fibroid tissue without incisions or general anaesthesia. This clearance enhances the company's ability to attract investment and partnerships as it seeks to advance non-invasive treatment options in Canada and potentially other markets​. This is also another example of a fusion system entering the market. As discussed in our Ultrasound Equipment 2024 Report, we forecast fusion imaging to be a growth market.

 Funding

7.     Sonavex has raised $15M through a Series A-2 financing round to support the evidence gathering process for its EchoMark and EchoSure platforms, part of which is its 304-patient randomised control trial that is currently enrolling patients. Sonavex has developed EchoMark a novel polymeric implant to enhance the imaging. The implant helps its EchoSure technology to collect arteriovenous fistula volumetric flow rate, diameter and depth information to support with maturation assessments at dialysis clinics.

 Partnerships/Acquisitions

8.     EchoNous has partnered with healthcare technology company Mendaera, which develops robotics and AI for medical procedures. The partnership will leverage Mendaera’s robotic platform and EchoNous’ Kosmos ultrasound platform to enable percutaneous procedures to be performed safely and more efficiently by providers. EchoNous’ technology will be offered as an add on option to Mendaera customers. The handheld ultrasound market is one that is challenging for vendors to be profitable in due to the lower cost of the devices. This will provide an additional revenue stream for EchoNous in a similar manner to how other vendors use subscription/membership platforms.

 9.     Smith+Nephew has entered a co-marketing agreement with JointVue for its OrthoSonic 3D Surgery Planning Technology. JointVue is currently the only company to deliver a 3D preoperative planning solution. The agreement will allow surgeons using the Smith+Nephew CORI Surgical System to create a surgical plan that is personalised to each Individual patient’s case, accounting for any anatomical differentiations. This will help to provide a more robust plan before a patient’s operation, to increase the efficiency of the procedure and enable the correct implants for the anatomy to be chosen ahead of time.

 10.  Hologic has reached a deal to acquire Gynesonics, a developer of intra-uterine ultrasound imaging, for $350 million. The Gynesonics Sonata system is a transcervical fibroid ablation treatment for uterine fibroids. It is the only intrauterine fibroid ablation system to use ultrasound technology to enhance targeting and improve the safety of the procedure. Hologic has a wide portfolio of healthcare solutions across women’s health. The addition of the Gynesonics technology further supports and expands upon its work to address healthcare inequities and provide women with minimally invasive options. With Hologic recently selling Supersonic Imagine, which had its breast ultrasound portfolio, it could suggest that Hologic sees the potential of ultrasound more in its obstetrics and gynaecology portfolio, rather than in breast imaging.

 11.  Deski  launched its new HeartFocus education app in partnership with Butterfly Network. The app will support new clinicians in learning to perform the 10 vital cardiac views with greater accuracy. The app supports personalised learning through customised and self-paced AI learning. The tool is available when using the Butterly iQ3 and iQ+ probes, and is available with a free six-month licence for the app when signing up on Deski’s customer portal. The app launch expands on the Deski’s partnership established earlier this year in June when the HeartFocus app joined the Butterfly Garden, Butterfly Networks ultrasound AI marketplace.

 Education is becoming increasingly important in POCUS, to help newer, less experienced users adopt ultrasound. The launch of the HeartFocus education app follows Inteleos’ POC academy and ThinkSono partnering in July 2024 to enhance healthcare professionals’ skills in detecting DVT. In May 2024, Clarius was integrated with POCUS Pro, which supports users learning ultrasound.

 12.  Pulsenmore has expanded its partnership with Clalit Health Services, Israel's largest HMO. Under the partnership Pulsenmore will supply 25,000 units, over five years, of its at home ultrasound device to support Clalit’s work to improve accessibility of high-quality prenatal care. The device will enable pregnant women to conduct both app guided, and clinician guided scans from home.

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 includes:

·       Ultrasound Equipment 2024

·       Ultrasound Transducers and Catheters

·       Ultrasound AI

·       Ultrasound Equipment 6 – month update

If you are interested in learning more about our Ultrasound service, please reach out.

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