Mobile phones become ultrasound devices, with numerous players in the handheld ultrasound market: GE, Philips, Feno...

Foreword

Wireless handheld ultrasound systems, also known as handheld ultrasound, transform traditional bulky, large ultrasound desktop machines into portable, mobile-sized color ultrasound devices. They feature powerful functions such as real-time composite imaging technology and automatic scanning, enabling high-quality images even with complex cases. Handheld ultrasound allows doctors to easily obtain rich and rapid diagnostic information, fundamentally improving the diagnostic process and patient care. Therefore, "handheld ultrasound" is also called "the stethoscope of the new era." Early handheld ultrasound devices were relatively expensive and had limited performance. In recent years, with the increasing maturity of technology, a number of innovative products have emerged on the market, including domestic handheld ultrasound devices, leading to greater acceptance of this technology. A Signify Research report statesHandheld ultrasound will experience peak growth from 2020 to 2025. By 2023, the global handheld ultrasound market is expected to exceed US$400 million!       

   Handheld Ultrasound Life Cycle 

I. Handheld Ultrasound Will Replace Traditional Stethoscopes

In 1816, French physician René Laennec invented the stethoscope. For the next two centuries, almost all doctors used stethoscopes. However, apart from electronic stethoscopes that amplify signals and filter noise, there has been little progress in the design and technology of stethoscopes. Ultrasound examinations provide anatomical and functional information without ionizing radiation. In the past five years, ultrasound diagnosis has largely replaced the stethoscope in cardiovascular, obstetric and gynecological, and gastroenterological diseases. Currently, handheld ultrasound has become a useful auxiliary auscultation instrument, allowing doctors to make rapid diagnoses at the bedside. It has been reported that emergency physicians in the United States are now being trained to perform abdominal and cardiac ultrasound examinations using handheld ultrasound. Handheld ultrasound is also used in obstetrics, critical care ultrasound examinations, and catheter replacement. A surprising result is that first-year medical students who received training in the use of handheld ultrasound had a higher accuracy rate in diagnosing cardiac abnormalities than clinical experts who routinely used stethoscopes. It is believed that in the near future, handheld ultrasound diagnostic devices suitable for clinical mass screening will have sound amplification, image display, and remote transmission capabilities, becoming a doctor's portable "visual examination device."  

II. The Future Development of Handheld Ultrasound: Entering the Home
 

Early adopters of handheld ultrasound included cardiologists, emergency room physicians, critical care personnel in intensive care units, and military personnel. Emergency medical care was the largest market for handheld ultrasound in 2018, with a size of approximately US$15 million. However, in recent years, in addition to the expanding application of handheld ultrasound in the traditional POCUS market, clinic doctors in various medical fields (such as urology, gastroenterology, and angiology) are also driving demand. Clinic specialists use handheld ultrasound for rapid examinations and preliminary screenings, as an aid to vehicle-mounted ultrasound. Relevant research shows that to date, the application of handheld ultrasound at the primary care level has been mainly limited to rural areas. In low- and middle-income countries, handheld ultrasound helps more patients obtain access to imaging examinations, mainly used for cardiac screening, pregnancy screening, and the diagnosis of respiratory and abdominal diseases.  Primary care is largely an untapped market for handheld ultrasound and may represent the greatest opportunity, with over 250,000 family doctors in the United States alone. In the past few years, the Price of handheld ultrasound has dropped significantly, making it an economical choice for many family doctors. For example, Butterfly Network began launching the Butterfly iQ product at the end of 2018, priced at US$1999 (plus a US$420 annual fee). In response, GE Healthcare lowered the Price of its Vscan basic version to US$2995 (currently limited to the United States). This Price reduction, combined with the emphasis on training family doctors in ultrasound, will truly bring handheld ultrasound into homes. Furthermore, in February 2020, the US FDA approved the first AI software for cardiac ultrasound imaging, which can help people other than ultrasound doctors obtain high-quality cardiac ultrasound images. In the future, handheld ultrasound will become a personal health management tool.
 

III. Typical Products of Handheld Ultrasound

Butterfly Network: Butterfly iQ 

Founded in 2011, Butterfly Network is one of the world's leading research and development companies of handheld ultrasound imaging devices. It is committed to leading the decentralized transformation of medical imaging through the research and application of "handheld ultrasound + AI." The Butterfly iQ ultrasound product is the world's first FDA-approved personal ultrasound device and the world's first single-probe, full-body ultrasound imager.
 

GE Healthcare: Vscan

GE Healthcare's Vscan handheld color ultrasound entered China in 2011. Its first generation, Vscan 1.0, was launched in the United States in 2008, causing a sensation and being named one of "Time Magazine's 50 Best Inventions of 2009" and "the top 100 technological achievements of 2010." The Size of the Vscan is 135mm × 73mm × 28mm, similar in appearance to a flip phone. It weighs 390 grams, has a battery life of one hour, uses color-coded blood flow imaging technology, and has a built-in beamformer in the probe to ensure image quality. The Vscan visual examination instrument has a wide range of clinical applications, suitable for measurement and analysis of clinical conditions in the abdomen, heart, urinary system, obstetrics and gynecology, and pediatrics, as well as detection of chest wall/pleural movement and effusion, and examinations in special care areas. After entering the Japanese medical market, the Vscan played a life-saving role during the Great East Japan Earthquake and tsunami. In April 2015, GE launched the new generation Vscan 2.0 Dual Probe with an innovative "two-in-one" probe, extending the range of applications for mobile portable ultrasound devices to the extreme. From heart, emergency, ICU to general practice, the new generation Vscan will play a more comprehensive diagnostic value.
 

Philips Healthcare: Lumify

Philips Healthcare launched Lumify in 2015. Lumify is about the Size of an Apple phone (it integrates an ultrasound sensor and special data conversion circuits). Color ultrasound images can be inserted into Smartphones or Others devices via a micro-USB interface and collected via an image management application (APP) on the device. The App can be downloaded from Google Play. This APP can also connect to the cloud, making it easy to share images, add markers, and send emails, so that data and imaging results can be obtained through Philips' HealthSuite digital platform. Users can also update through Philips' targeted platform to obtain new functional applications to improve their user experience. Lumify provides an on-demand, instant diagnosis in multiple interconnected environments.  

Emagine Solutions Technology: VistaScan 

Emagine Solutions Technology is a technology company that provides mobile ultrasound imaging technology. Emagine Solutions Technology's VistaScan allows clinicians to make immediate diagnoses of patients on-site, in transit, or at the bedside. Compared to traditional cart-based ultrasound, it saves both time and 90% of the costs. VistaScan was FDA-approved in February 2020.
 

Domestic
 

Fyeeno: VINNO Q 

Founded in 2010 and headquartered in Suzhou, Feiyino is a provider of digital ultrasound equipment and medical information solutions. It is a high-tech enterprise specializing in the R&D, production, and sales of high-end digital color ultrasound diagnostic instruments and related technologies. Feiyino currently has more than 450 employees, holds over 200 patents, has passed ISO13485:2012 quality system certification, obtained product registration from the National Medical Products Administration (NMPA) and EU CE certification, and won the Italy A'Design Gold Award for Medical Device Design. Its products have been successfully exported to more than 80 countries worldwide. Since its establishment, the company has launched more than 20 color ultrasound diagnostic instrument products, with applications covering cardiovascular, abdominal, obstetrics and gynecology, small organs, musculoskeletal and other clinical Applications. Currently, Feiyino's VINNO Q series handheld ultrasound has three probe Models: convex array, linear array, and phased array, enabling whole-body applications in abdomen, obstetrics and gynecology, superficial tissues, small organs, peripheral vessels, urology, ICU, anesthesiology, emergency, and interventional procedures.
 

U-Tour Technology: MU3C 

Chengdu U-Tour Technology Co., Ltd. was established on June 29, 2011, in Chengdu High-tech Zone. It is a high-tech enterprise focusing on the R&D, production, and sales of portable and intelligent ultrasound imaging equipment. The company's main products include intelligent mobile ultrasound imaging equipment (terminal type and tablet type), ultrasound imaging modules (adaptable to medical integrated machines and various Android/Windows medical devices), and intelligent ultrasound diagnostic application software. The mobile ultrasound imaging equipment produced by the company not only fills the gap in the lack of ultrasound imaging equipment in China's primary medical institutions but can also be widely used as a portable ultrasound visualizer in clinical medicine, replacing traditional stethoscopes, improving clinical diagnostic methods, and increasing clinical diagnostic efficiency. The all-digital handheld ultrasound diagnostic instrument MU3C is China's first handheld ultrasound visualizer.

SonoStar: Handheld Ultrasound 

Guangzhou SonoStar Information Technology Co., Ltd. is a professional medical equipment R&D, manufacturing, and sales company. The company has a strong product development and application team. The main members have extensive industry experience, forming a complete talent team covering acoustics, electronics, software, mechanics, structure and appearance design, and clinical applications. SonoStar has obtained EU CE and ISO certifications from top certification bodies. Products are sold to more than 100 countries and regions worldwide. The company's "Sonostar" Brand is widely recognized by customers and enjoys high reputation domestically and internationally. SonoStar's representative products include a three-in-one wireless probe B-ultrasound/color ultrasound with convex, linear and phased arrays.
 

Why is handheld ultrasound more promising in China?
 

1. Policy Support
 

In 2017, the Ministry of Science and Technology of China listed portable handheld ultrasound as a key national research and development project during the 13th Five-Year Plan. Subsequently, handheld ultrasound began to emerge in major professional forums and exhibitions. For example, at the "Promotion and Application Symposium of Domestic Portable Handheld Ultrasound" held in November 2017, guided by the Chinese Medical Equipment Association and hosted by the Ultrasound Equipment Technology Branch of the Chinese Medical Equipment Association, the importance and necessity of the promotion and application of domestic portable handheld ultrasound in specialized and primary-level medical institutions were fully affirmed. The new favorite "handheld color ultrasound" marks a new development in the industry. Most domestic handheld ultrasound products in China were approved for marketing around 2017. In addition, in recent years, the national government and various provinces have successively introduced a number of policies, setting multiple indicators such as priority use of domestic products and domestic product rate in procurement, strongly supporting the development of domestic medical devices.
 

2. High Demand in Primary Medical Institutions
 

The period of large-scale construction of primary medical institutions in China is still ongoing, and the development of primary medical care continues to expand. The number of secondary hospitals and primary medical institutions and the number of outpatient visits are still in a period of rapid growth. At the same time, the construction of the primary market also depends on the support of professional medical personnel. Data from the "60th Anniversary Academic Conference of Ultrasound Diagnosis in China" shows that in 2017, there were only 120,000 registered ultrasound doctors nationwide, and experts at the conference estimated that the current shortfall is at least another 150,000, indicating significant room for improvement. With the continuous introduction of handheld ultrasound products, the National Health Commission has gradually launched education and training on clinical ultrasound applications, including handheld ultrasound, in order to improve the professional skills of clinical doctors and enhance their "soft power" in health checks and diagnosis. This aims to alleviate the current imbalance in the distribution of medical resources and the shortage of medical equipment in remote areas, promoting fair and universally accessible medical services.  

Conclusion
 

The miniaturization of ultrasound is an increasingly clear development trend. It is hoped that handheld ultrasound can enable ultrasound equipment to move beyond the imaging departments of secondary and tertiary hospitals, reaching primary medical institutions, clinical departments, and even homes, truly solving the problems faced by primary medical care.