Precision and diagnostic accuracy will be the key factors deciding acceptance and market penetration of about 176 diagnostic imaging devices currently at various stages of development. This article uses the Medical eTrack Products Pipeline Database to identify those products and technologies that are expected to revolutionalise the way healthcare professionals diagnose and treat life-threatening conditions.
There are about 24 mammography products under different stages of clinical investigations, but the following devices, when launched, are the ones expected to make diagnosis of breast cancer more accurate with minimum instances of false positives and false negatives.
Digital breast tomosynthesis (DBT)
Being developed independently by GE Healthcare, Siemens Healthcare, the US-based Hologic and the UK-based Dexela Limited, the DBT-based mammography system acquires, processes and visualises data from 3D X-ray images making it easier than ever before to detect tumors even in dense breast tissues. DBT reconstructs a 3D composite image from a series of 11, low-dose 2D images, enabling physicians to view the interior of the breast without hindrance from surrounding superimposed breast tissues.
This results in identification of tumors that are easy to miss with the conventional 2D approach. Currently under clinical investigations, the system, once approved, is expected to redefine the breast cancer diagnosis and treatment landscape.
Computed tomography laser mammography (CTLM) system
Currently under development, the CTLM system from Imaging Diagnostic Systems Inc. is a non-invasive device that uses lasers to image the breast. Unlike an X-ray mammography system, CTLM images blood haemoglobin and the process of new vessel formation, a physiological development often associated with breast cancer.
The system images through breast implants and dense breast tissue easily, which traditional mammography finds difficult to penetrate. With its ability to visualise tumors in the evolving process, CTLM is expected to provide early diagnosis and hence early treatment, leading to breast-sparing surgery and less trauma to the patient.
Imaging Diagnostic Systems, Inc. is currently collecting data from clinical sites for the future filing of a US Food and Drug Administration (FDA) Premarket Approval (PMA) for its CTLM system.
Amulet full field digital mammography (FFDM) system
Fujifilm Corporation’s Amulet is the world’s first digital mammography system equipped with the direct conversion flat panel detector (FPD) technology. The system provides a small pixel size of 50µm yet produces both high-resolution and low-noise images, making image quality its key feature.
The product is also said to offer the opportunity for reduced dose and enhanced workflow efficiency. Already launched in Japan, it is awaiting FDA approval nod for sale in the US, where it is expected to be marketed under the Aspire brand of breast imaging products.
The US launch of this system will make Fujifilm the first women’s healthcare company offering both computed radiography (CR) and digital radiography (DR) FFDM solutions.
Computer tomography (CT)
Dominion Vi 3D medical imaging scanner
The Dominion Vi 3D medical imaging scanner being developed by the Californian-based Imaging3 Inc. employs high-resolution photo-fluoroscopy to produce 3D diagnostic images on a real-time basis. Since these images are produced real time, they have the potential to be used for any current or new medical procedure that requires multiple frames of reference to perform the procedure in the human body.
In April 2008 Imaging3 received the US FDA approval to begin distributing the product for evaluating its effectiveness in the clinical setting. Touted by the company as a safer and cost-effective alternative to CT scanning, the device stands to benefit many medical specialities, including trauma, cardiology, pain management, paediatrics, orthopaedics, sports medicine, vascular, and neuro-vascular.
Magnetic resonance imaging (MRI)
There are about 20 MRI systems at various stages of development that will transform the MRI technology landscape. Several, however, are expected to revolutionise MRI-based diagnosis.
11.7T MRI system
Being developed by the French Atomic Energy Commission (CEA) in collaboration with Siemens Healthcare and Alstom Magnets and Superconductors, within the framework of the French-German consortium Iseult/INUMAC (Imaging of Neuro disease Using high field MAgnetic resonance and Contrastophores), the 11.7T MRI system is expected to address clinical applications of ultra high-field (UHF) MRI.
7T MRI system
The 7T MRI system, while offering the potential for microscopic spatial resolution, also enables the observation and analysis of tissue metabolism and function.
A Siemens Healthcare development, 7T MRI systems are investigational devices and are not available for clinical use. Currently, they are being used only for clinical research and not for clinical diagnosis.
It is expected that the 7T MRI system will make it possible to study neuronal function at the sub-millimeter scale. Potential clinical applications include neurodegenerative diseases like Alzheimer’s.
Renaissance system 1000
The product of a partnership between US-based ViewRay, Inc. and Siemens Healthcare, the Renaissance System 1000 combines MRI and gamma ray radiotherapy technologies to provide real-time beam-on imaging and targeting of the tumor.
MRI coil devices
Being developed by the US-based Tursiop Technologies LLC, the nanomaterial-based MRI coil devices are expected to produce better image quality and faster scan times, thus boosting the functional capabilities of any installed MRI system.
XCounter AB from Sweden is behind the XCT -3T, a 3D digital tomosynthesis technology that captures 3D digital X-ray images, resulting in high-resolution imaging at low levels of radiation. The Swedish company is pursuing the development of four systems.
They are the XC Mammo -3T, a prototype system for 3D digital breast tomosynthesis screening; the XC MP-3T, a 3D general-body imaging system; XC Cardio -3T, a cardiac-imaging system designed for 3D functional imaging of the heart; the Cardio -4T, a cardiac-imaging system designed for repetitive 3D imaging of the heart.
Magnetic particle imaging (MPI)
Magnetic particle imaging (MPI) technology uses magnetic properties of iron-oxide nanoparticles injected into the bloodstream to generate real-time images of arterial blood flow and volumetric heart motion. Because the human body doesn’t naturally contain nanoparticles, the MPI technology, by combining high spatial resolution with short image acquisition times, captures dynamic concentration changes as the nanoparticles flow along with the bloodstream.
Currently in pre-clinical stages, the first 3D imaging results with this system were announced by Philips Healthcare, the company developing the technology, in March 2009. The company was the first in the world to demonstrate the use of MPI in producing real-time in-vivo images, which capture cardiovascular activities, accurately and in real-time.
It noted that by augmenting important functional details to the anatomical data obtained from conventional modalities such as CT and MR, the MPI technology has the potential to help in the diagnosis and treatment planning of major cardiovascular diseases such as atherosclerosis and congenital heart defects.
Academia in action
Researchers at the University of California, Davis Campus in the US have successfully combined the technological capabilities of positron emission tomography (PET) and magnetic resonance imaging (MRI) to build a single scanner – the MRI/PET scanner. While combination scanners that combine computer-assisted tomography (CAT) and PET scans are already available in the market, the fact that CAT scans provide less structural details (especially of soft tissues) than MRI scans, makes the MRI/PET scanner a breakthrough technology, which is under development. As standalone units, MRI scans provide high-quality structural images but hardly any functional detail; whereas PET scans show body processes but no structural detail.
Fe8 Scientists at the National Institute of Standards and Technology in collaboration with researchers at the Florida State University and the University of Colorado at Boulder in the US have invented a magnetic molecule, named Fe8, that is harmless, predictable and thus a highly effective contrast solution with potential to be used in medical imaging.
As should be clear from our product and technology profiles, precision and diagnostic accuracy remain the key innovation areas of interest, and it’s not just the imaging giants but also the small and medium manufacturers that are expected to bring dynamism to the diagnostic imaging technology landscape.
imaging on the way
There are 176 diagnostic imaging devices currently at various stages of development.
About 24 mammography products are under different stages of clinical investigations at present.
It is estimated that some 20 MRI systems are at various stages of development.
In 2008 the global diagnostic imaging market was worth $16bn.
State of the global diagnostic imaging market
In 2008 GE Healthcare, Philips Healthcare and Siemens Healthcare together accounted for more than 70% of the global diagnostic imaging market, which was valued at $16 billion. With a combined pipeline portfolio of about 20 products at different stages of clinical investigations, GE, Philips and Siemens are well positioned to further penetrate a market that is forecast to grow at 6% annually for the next seven years to reach $24.2 billion by 2015.
Source: Medical eTrack