Ultrasound News Round Up - February

February was another busy month awash with ultrasound announcements. Most of these announcements were for products receiving regulatory clearance, including several educational solutions. 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, including those from the ongoing ECR conference.

ECR

1.     GE HealthCare launched its new LOGIQ ultrasound system, LOGIQ Totus. It has been designed to be an accessible and affordable shared service solution to customers, with AI tools (the breast and thyroid solution from Koios Medical), and tools such as Scan Assistant and Voice Control to help streamline workflows. The LOGIQ Totus also integrates the handheld Vscan Air CL probe. This will allow the LOGIQ Totus to be used wirelessly to assess patient needs in a variety of clinical scenarios, such as in interventional radiology. This is also now available with the other LOGIQ systems, E10, E10s and Fortis.

In addition of launching LOGIQ Totus, GE HealthCare has also added the LOGIQ AppAPI, to integrate third-party applications beyond Verisound digital offerings. LOGIQ AppAPI will allow collaboration with third parties on applications that run directly on the LOGIQ system, or use real-time streaming of ultrasound data to run side-by-side with the LOGIQ system. PIUR IMAGING’s ‘PIUR tUS inside’ is one of the first integrated LOGIQ AppAPI partners, along with Koios Medical.

The LOGIQ Totus will allow GE HealthCare to cater to customers with different clinical needs and budgets. This follows the trend of more affordable solution launches from other vendors. However, GE HealthCare hopes its AI tools and new voice control solution will set it apart. The voice control solutions is like tools by Clarius Mobile Health (for handheld ultrasound devices), and FUJIFILM Sonosite, Inc. for its compact systems (see point 7). This should also position LOGIQ Totus, and its other LOGIQ systems, ahead of its nearest cart-based competitors in the radiology market. The LOGIQ AppAPI is another example of the GE HealthCare’s aggressive strategy to stay progressive in the ultrasound AI/software side, with its investment in Pulsenmore and its acquisition of Caption Health being other examples.

 2.     Canon Medical Systems Corporation unveiled its new Aplio Me shared service system. Highlights of the system include; high performance and compactness, versatility, quietness when in use, to ensure a calm environment for both patients and healthcare professionals, AI Integration to enhances workflow efficiency, and sustainability regarding its energy consumption.

 3.     Philips has also launched new versions of its radiology portfolio to the European Market at ECR; the Epiq Elite, Affinity and Compact 5000. This release comes with a focus on consistency across systems to aid users when switching from one machine to another. It also comes with new features such as AutoScan to optimise the workflow and reduce keystrokes, expanded use of its Collaboration Live solution and a new hockey stick transducer, which won the Prix innovation 2023 award.

These releases by GE HealthCare, Canon medical and Philips are further examples of vendors widening and refreshing their product portfolio to meet the varying needs, and budgets of customers.

 New Solutions Receive Regulatory Clearance

4.     Taihao Medical Inc. received MFDS approval for its BR-FHUS Smart System solution enabling them to enter the Korean market. The BR-FHUS Smart System is a breast screening AI solution designed for handheld ultrasound, enabling lesions to be recorded and alerted in real time. With the solution also having CE mark, Chinese NMPA Class II, Japan PMDA and FDA clearance, it is becoming an increasingly available offering for customers looking to conduct breast imaging in rural areas.

5.     iCardio.ai announced in February that is has received FDA Breakthrough Device Designation for its Aortic Stenosis screening product. The AI solution is designed for detection of Aortic Stenosis in point of care settings. iCardio.ai can accurately identify moderate to severe aortic stenosis enabling early and accurate diagnosis facilitating timely interventions. The company’s partnership with Butterfly Network, Inc. will enable better cardiac care outside of the clinical setting and within rural areas.

New Product/Solution Releases

6.     The announcements don’t stop there for icardio.ai. As well as an FDA breakthrough registration and following on from their partnership with UltraLinQ Healthcare Solutions in January, in February they have also partnered with deepc. With iCardio.ai partnered with Butterfly Network, UltraLinQ and now deepc, they are fast becoming an ultrasound AI vendor with one of the most accessible solutions.

 7.     FUJIFILM Sonosite, Inc. has released a voice command solution available in some of its SonoSite ultrasound units. It allows the ultrasound systems to be controlled from a distance, which is useful for sterile procedures.  The voice command allows sonographers to access most of the system's critical features, such as the ability to freeze and save images, adjust gain settings and add colour flow, without the need to touch the unit. The voice command feature also allows for an assistant to help complete an exam without needing to be in the same room as a patient, facilitating a safer, cleaner environment.

Clarius were the first to introduce a voice control feature in May 2023 for its handheld devices. The solution from Fujifilm SonoSite is the first to be available for compact ultrasound systems. Whilst this solution is unlikely to win sales on its own, it can certainly be the icing on the cake to keep Fujifilm SonoSite ahead of its closest rivals in the competitive POCUS market; GE HealthCare and Mindray.

 8.     PIUR IMAGING GmbH launched its new solution, the PIUR tUS Infinity 4, which can be added to any standard ultrasound system to provide diagnostic tomographic 3D imaging of the thyroid. An entire thyroid lobe can be captured in a single sweep.

The PIUR tUS Infinity 4 introduces improvements over its predecessor including; enabling tomographic ultrasound acquisitions twice as fast, a new user interface; advanced background image processing to speed up image analysis; a next Generation PIUR Sensor G3; one-click segmentation of thyroid nodules and enhanced manual correction tools

Due to the time it takes to interpret thyroid studies, providers make little or no profit on these exams. Solutions like PIUR tUS Infinity 4, as well as AI solutions being developed to assist with thyroid imaging, will aim to simplify the complex process of thyroid imaging.

Educational Product/Solution Releases

9.     Ahead of the SMFM pregnancy meeting, Boston Imaging - A Subsidiary of Samsung Electronics Co., Ltd. launched the Samsung Ultrasound Institute of Technology and Education (theSUITE). This is a new Women's Health ultrasound digital platform for sonologists, sonographers and healthcare professionals. theSuite provides access to live training events, community forums where users can interact and network, and an education hub for obstetrics and gynaecological clinical specialties. theSUITE is equipped with application tips to help users maximise their use of Samsung’s ultrasound systems and keep them aware of the latest industry breakthroughs.

 10.  After receiving its CE Mark for its PAL HD3 scanner and FDA approval for its Bladder AI solution in January, in February Clarius Mobile Health has released its AI-based educational ultrasound anatomy tool - T-Mode TM AI. This solution creates a split screen during an exam that displays a colourful anatomical image with labels next to the grayscale ultrasound image. It is available now for aesthetics and plastic surgery applications with Clarius' wireless ultrasound devices, and is intended for educational and training purposes only. With many newer users of ultrasound in the aesthetics and plastic surgery market, this solution can help to build user confidence in the modality.

 11.  Intelligent Ultrasound unveiled its portable 'NeedleTrainer Plus', an ultrasound-guided needling training simulator. It is catered to military field-based hospitals and clinical networks in remote areas, and comes equipped with a GE HealthCare Vscan handheld ultrasound device. It uses a retractable needle and virtual image overlays to replicate needling procedures on live volunteers, facilitated by real-time ultrasound scans.

 Partnerships and Other

12.  UltraSight announced its partnership with SELVAS Healthcare, Inc., which start the introduction of UltraSight's real-time AI guidance technology in Asia. This will begin with the regulatory process for approvals that may lead to eventual commercialisation and distribution in Korea and the Southeast Asian market.

13.  Sonus Microsystems has raised $2.1M in pre-seed funding totalling nearly $3M raised by the company. Sonus Microsystems has developed customisable Polymer-based Capacitive Micromachined Ultrasound Transducers (PolyCMUTs). The technology enables the transducers to be utilised in various applications including screening, diagnostic imaging and monitoring as a wearable device. With the funding, the company will look to grow its engineering capacity and identify new application areas. Whilst new handheld vendors such as Sonus Microsystems will further increase market competition, (when it receives FDA clearance) it is unlikely to directly compete with the major established handheld ultrasound vendors, instead focusing its strategy on new clinical areas and remote monitoring.  

 14.  Deepecho has deployed its Fetal Ultrasound AI on Butterfly Garden. DeepEcho is utilising Butterfly’s software development kit to aid in the build and deployment of prenatal solutions. The partnership aims to improve new born health services by increasing the efficiency and accuracy of prenatal diagnostics through the development of an antenatal AI guidance solution. Developing prenatal AI solutions for handheld ultrasound devices increases women's accessibility to high-quality antenatal care in rural and developing areas. This announcement will further strengthen the new Butterfly Garden, which will be further bolstered as more solutions receive commercial clearance.

 15.  There was further good news for Butterfly Network, Inc. who, after officially launched the Butterfly iQ3 in the United States. However, there was also some less positive news for Butterfly Network with its annual financial results published at the end of February. Despite 12% growth in its software sales, its device sales were down 20%, with overall sales down 10% versus 2022. Whilst Butterfly Network saw 2023 as a transition year, as it refocused its growth and product strategy, this is still a blow for the company. The company will hope that as handheld ultrasound becomes more widely used, its new IQ3 device, and increased software capabilities will help the company recover its declining device sales and return to profit.

 16.  Researchers from the USC Viterbi School of Engineering, Keck School of Medicine of the University of Southern California, and the MIT Department of Mechanical Engineering (MechE), have developed an adhesive “wearable ultrasound” shear wave elastography, known as BAUS-E.  Scholars at USC incorporated a bio-adhesive hydrogel fabricated by MIT researchers to adhere a wearable ultrasound device to the skin for ongoing monitoring of the liver stiffness changes for a period of two days (48 hours). The wearable ultrasound device developed by USC and MIT researchers was able to identify liver stiffnesses within six hours of its onset. This isa timeframe that if applied to post-operative liver transplant recipients and could allow a window of opportunity for doctors to tend to a patient’s deteriorating condition. Their paper was published in Science Advances and it is believed to be the first wearable ultrasound device that can perform ultrasound shear wave elastography with longitudinal measurements in organs.

Similar technology has been developed already for other clinical areas, such as the patch developed by Hu et al., for continuous cardiac imaging. These patches are very much at the academic research stage, and it will be years before they enter the commercial market. However, the potential impact of these patches could be huge and will be fascinating to follow. Not only can they improve patient care, by negating the patient need for regular hospital visits, but also improve hospital efficiency by reducing the number of people going to hospitals for imaging. 

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:

·       Ultrasound Equipment 2024

·       Ultrasound Transducers and Catheters

·       Ultrasound AI

·       Ultrasound Equipment 6 – month update

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