Hand-held X-rays have been used extensively in dental and industrial applications over the last two decades. The first hand-held portable dental X-ray devices date back to the early 90’s with intended use in the military field. 2018 was the year the launch of the hand-held X-ray devices in an envisioned medical application; Fujifilm’s Calneo Xair was launched in October 2018, and the Micro C device also was launched in September 2018. However, speculation still looms over how successful these novel X-ray devices will be in proving their clinical and economical benefit. Will hand-held X-ray devices be embraced with the same triumph as the hand-held ultrasound market?
Applications of hand-held X-ray systems
Hand-held X-rays are expected to have highest usage in specific cases where it is impractical or impossible to transfer the patient to a fixed mounted X-ray installation. Such examples include:
- Operation theatres where no fixed mounted X-ray unit is available, and the patient is under general anesthesia or sedation
- Emergency rooms, surgical suites, patient rooms, or other hospital facilities for immobile patients
- Nursing homes or residential care facilities, where patients that have limited mobility and who are unable to attend a healthcare facility
- Prison or detention center facilities where inmates are physically confined
- Sedated and special needs patients
- Emergency transportation for pre hospital assessment
- Outreach programmes such as dental camps
- Home healthcare
- Forensic work
Hand-held X-ray versus conventional X-ray
The design of hand-held X-ray systems is tailored towards overcoming some of the barriers which conventional mobile X-ray imaging systems currently present. Hand-held X-ray systems provide immediate diagnosis for critically ill patients, where there is a higher propensity amongst the rapidly aging society, as well as being able to provide pre-hospital medical treatment.
Challenges faced by hand-held X-ray devices
Despite the numerous advantages from a clinical, ergonomic and financial standpoint that hand-held X-ray systems offer, there are still significant considerations and drawbacks which need to be addressed for successful uptake of these innovative products:
- The main drawback is that the gold standard for dose administration, As Low As Reasonably Achievable (ALARA) principal, is not followed
- The device must be angled, and the operator cannot be within the protection zone
- Occasionally the radiofrequency which is used to produce X-ray can disturb other operating machines
- An experienced operator is required
- The lack of water resistance of the X‐ray radiating apparatus, and the cassette potentially unable to work well at low temperatures
- It is time consuming to set up the frame in the emergency setting
- A compulsory lead apron is required to be worn by the operator
- Quality of the X‐ray image when the system is operated by medical staff who are not radiologists
How do the Calneo Xair and the Micro C device compare?
The Calneo Xair is designed for intended use in out of hospital settings to provide remote healthcare and diagnostic imaging capabilities, whereas the Micro C device has a different proposition with the main application being in orthopaedic surgery.
Fujifilm’s Calneo Xair (Fujifilm's first-ever portable X-ray unit) was introduced first at RSNA 2018 and re-showcased at RSNA 2019. However, with FDA approval still pending, there has been no real progress with real clinical or economic analysis, to prove the competitive or clinical advantage of the hand-held X-ray device against more conventional mobile X-ray solutions.
As the movement of ‘out-of-hospital’ care continues to soar globally, alongside the global rise in the geriatric population, there is an increasing need to ensure care is provided for patients who are unable to attend a hospital facility. As a result, the Calneo Xair is believed to be a potential game changer to address this universal trend, enabling high quality X-ray imaging in the form of remote diagnosis and plans to eliminate the heavy reliance of C-arm systems. The Calneo Xair has been designed to reduce the physical burden on physicians and technicians in terms of transfer and preparation.
The Micro C on the other hand, is designed for surgeons and physicians treating disorders of the extremities and combines a compact, hand-held X-ray and digital and infrared camera and image receptor with software and consumables. The Micro C device is positioned to offer a fluoroscopy solution for both clinical and surgical applications that is faster, safer and more agile than current C-arm technology. The markets where Micro C devices are considered to have highest uptake and usage are tier 1 hospitals and surgeries, military and correctional facilities, and nursing homes and home healthcare.
FDA clearance for the Micro C device has also been pending for several years but it is alleged that FDA clearance will be granted by early 2020, with subsequent initial distribution of 20 Micro C systems in the United States. FDA approval and first-time usage of Micro C systems will then initiate studies to assess image quality, radiation emission and clinical testing of efficiencies against traditional devices, with findings to further fuel enhancements for a greater relaunch towards the end of 2020.
Future studies are needed to assess the utility of hand-held X-ray devices
The Fujifilm Calneo Xair is currently being tested in emergency transportation cases in Japan. However, more extensive studies are required to fully assess the true effectiveness of this product, with no real studies comparing their clinical effectiveness or cost effectiveness. In the trauma setting, portable ultrasound machines are a new effective and sensitive tool for evaluating chest trauma, such as cardiac tamponade, pneumothorax, hemothorax, or even rib fracture, which could be a potential threat for hand-held X-ray devices in this setting. However, ultrasound is a point‐of‐care system and is not appropriate for diagnosing abnormalities in the entire chest structure, such as the volume of pneumothorax, the number of rib fractures, mediastinal abnormality, or the position of foreign bodies, including iatrogenic foreign bodies. Case studies have currently failed to find any improvement of the patient's final outcomes using hand-held X-ray systems. However, once FDA approval has been authorized for either devices, and more extensive clinical use cases will fuel product enhancements, the mobile X-ray imaging landscape is forecast to promise change in 2021. It is predicted that Micro C will be at the forefront of adoption of hand-held X-ray technology with FPA approval almost being in arms reach.
IHS Markit Healthcare Technology will continue to track this market qualitatively as part of its X-ray Intelligence Service.