industry news

Researchers at Cardiff University in the UK have developed a new test, dubbed STELA, to quickly predict how a patient with a common type of leukaemia would respond to standard therapy.

The test could help doctors make better decisions on treatment plans for chronic lymphocytic leukaemia (CLL) patients. It is intended to identify whether the cancer will develop and how fast this could happen.

CLL tends to affect white blood cells slowly over many years. It mostly affects people over the age of 60, is rare in people under 40 and almost never affects children.

Unlike its previous versions that took one week to process, the test is said to now deliver results within a day.

STELA is designed to measure the length of DNA sections in cancer cells called telomeres present at the end of chromosomes.

Each time a cell divides to create a new one, telomeres shorten and the chromosome ends are exposed over time. This exposure is said to cause extensive DNA damage that drives cancer progression.

The Cardiff research, which was funded by Bloodwise, revealed that patients carrying very short telomeres at the time of their diagnosis are much more likely to progress faster.

Bloodwise research director Alasdair Rankin said: “People with CLL can experience great anxiety and uncertainty about how their cancer will progress. This test could give people the peace of mind that they will receive the most effective treatment possible if it does. It may even allow some people to be told that their cancer is unlikely to progress.”

To assess the test’s latest version, the team analysed samples from 260 patients. The study aimed to determine STELA’s ability to predict patient response to intensive chemotherapy plus immunotherapy.

The test demonstrated that people with short telomeres relapsed within an average of 3.7 years, compared to 5.5 years in case of those with long telomeres.

Cardiff University School of Medicine professor Duncan Baird said: “Not all patients benefit equally from chemotherapy and this test is the only one available that can accurately predict how patients are likely to respond.”

Calling the new test a ‘game changer’, the researchers said that the technology has the potential for application in other types of cancers, including myeloma and breast cancer.

Researchers at Harvard University in the US have designed a probe that looks, acts and feels like a real neuron so that the brain does not identify it as a foreign object and try to attack it.

Professor Charles Lieber and his lab colleagues authored the study, which has been published in the journal Nature Materials.

The probes have been designed to be directly implanted into brain tissue and survive as long as possible in the organ’s warm and humid environment. Each probe consists of sensors within a protective casing that can send data back to researchers.

Information from the devices, such as how and when individual neurons fire and neural circuits communicate, could highlight ways to treat neurological conditions like Parkinson’s disease, reverse the neural decay linked to Alzheimer’s and ageing, and could even enhance cognitive capabilities, the researchers said.

Current brain implants designed to gather similar results are said to trigger the brain’s foreign body response because they are too stiff and large compared to real neurons and neural tissue. Brain signals are difficult to capture beyond scar tissue and rigid probes cannot move position so become redundant.

Harvard fourth year graduate student and first author of the study Xiao Yang said: “The stereotype of the neural probe is that they are giant compared to the neuron targets that they’re interrogating. But in our case, they are essentially the same.”

To make the microscopic tools, Yang and her colleagues used photolithography, which uses light to transfer a pattern on to material, and built the probe’s four distinct layers of metal and polymer one at a time.

Once built, the team used a syringe to inject 16 of their cell imitators into the hippocampus region of a mouse brain. There, they unfold to create a porous web that imitated the brain’s crisscrossing neuron network.

The study found that newborn neurons may use the artificial neuron-like electronics as a scaffold to reach damaged areas of the brain and help regenerate tissue.

Yang is now working to design even smaller and more flexible probes and explore the potential of neuron-like electronics serving as active scaffolding for regenerating neural tissue in vivo.

Philips has unveiled a new mixed reality concept to aid in minimally invasive surgeries, which it has developed with Microsoft, at the MWC 2019 mobile technology conference in Barcelona, Spain.

The new mixed reality concept intended for the surgeons of the future is based on the Philips Azurion image-guided therapy platform and Microsoft’s HoloLens 2 holographic computing platform.

Current minimally invasive surgeries rely heavily on advanced medical imaging technologies such as ultra-low-dose X-ray imaging and ultrasound, to guide surgical actions inside a patient. Philips often provides high tech interventional suites and hybrid operating rooms for such procedures.

The Philips and Microsoft augmented reality concept, built for HoloLens 2, has been designed to bring live imaging and other sources of vital data currently displayed on large 2D screens into a 3D holographic augmented reality environment that can be easily controlled by the physician.

Philips chief medical officer for image-guided therapy Dr Atul Gupta said: “The transition from open surgery to image-guided procedures has driven a seismic shift in improving patient outcomes and reducing costs, not least by dramatically reducing the length of time a patient stays in a hospital after their procedure.

“On our Azurion platform, we seamlessly integrate a range of data sources in a way that’s intuitive to understand and control. By collaborating with Microsoft and HoloLens 2 we can take it to the next level, immersing the physician in a tailored augmented reality environment.

"This concept allows me to see the real world superimposed with the live data and 3D medical imagery needed to guide our precision therapy, and importantly also lets me control Azurion with voice recognition, eye tracking and advanced gestures. It’s all about keeping our focus on the patient.”

Microsoft AI and mixed reality technical fellow Alex Kipman said: “Mixed reality is giving people new ways to interact with the digital and physical world, bringing the benefits of the digital revolution to entirely new experiences across the globe.

“I am thrilled to see companies in a broad range of industries achieve more using the products that we build with our partners and ecosystem. Mixed reality holds great potential in healthcare, and our collaboration with Philips shows how that potential is already beginning to be realised.”

The US Food and Drug Administration (FDA) has issued draft guidance to drive the development of brain-computer interface (BCI) devices, a new generation of implants that could provide users with direct control.

BCI devices are often used to regulate limb prosthesis. The direct control feature of these implants is expected to enable significantly more mobility and independence for patients.

The regulatory agency added that the devices possess the potential to help people living with severe disabilities by improving their ability to interact with their environment.

Recently, FDA Center for Devices and Radiological Health held a workshop focused on BCI devices, which were defined as brain implants that communicate with a patient’s nerves and muscles in order to help them gain mobility or a sense of touch.

The agency said that an outcome of the workshop was the initiation of the draft guidance, which will be open to public comment as it is finalised. This guidance is intended to help developers, as well as maintain necessary protections for patients.

FDA commissioner Scott Gottlieb referred to the draft guidance as a ‘leap-frog’ guidance to help bridge current technology with future innovations.

Gottlieb added: “This is a critical area of development for the millions of people who suffer from conditions that inhibit their mobility. Today, we’re issuing draft guidance to help spur development of BCI devices for patients with paralysis or amputation, including our nation’s veterans.”

The draft guidance outlines recommendations for developers on non-clinical testing and clinical study design that could be leveraged to create BCI devices for patients with paralysis or amputation.

Specifically, the FDA is offering detailed technical advice and recommendations for study designs to support safety and effectiveness.

The UK Government is considering creating a compulsory medical device register, which could register every implantable device in every patient so that healthcare professionals will be able to tell if a medical device is causing harm to a patient.

Health minister Jackie Doyle-Price revealed the plans during a short parliamentary debate when she was asked to respond to the International Consortium of Investigative Journalists (ICIJ) Implant Files investigation by introducing a compulsory medical device register.

She said: “This is a matter already under consideration by the Department [of Health and Social Care], and it’s linked to our wider digitisation of agenda for the NHS. We have the technology, so we should use it in the interests of patient safety.”

The MPs were speaking during a medical device regulation debate called by Labour Party MP Owen Smith, who is a leading campaigner for women whose health has been negatively impacted by vaginal mesh implants.

At the start of the debate, Smith said: “My principal point this evening is that the regulatory system that we have for medical devices in our country and across Europe, and arguably across the wider world, is simply not fit for purpose and must be properly reformed.”

Last year, the ICIJ, in coordination with the British Medical Journal and various media outlets, carried out an investigation that found that unsafe medical devices have been implanted in patients and have already caused great harm to many.

The probe found that pacemakers, artificial knees, hips and rods to support the spinal cord are among the faulty devices, which have been implanted in patients. It also found that some of these unsafe devices had not even completed patient trials before their commercial launch.

The Royal College of Surgeons has also called for a medical device register to be created, with its president Professor Derek Alderson telling the BBC in November last year: “All implantable devices should be registered and tracked to monitor efficacy and patient safety in the long-term.”

German health ministers proposed a similar register at the start of 2019 as they were also promoted by the ICIJ investigation.

A team of Swiss and Italian researchers has developed a bionic hand to help amputees regain their proprioception, an instant and accurate sense of the position of limbs during and after movement.

The next-generation prosthetic is a result of a collaboration between the École polytechnique fédérale de Lausanne (EPFL) in Switzerland, and the Sant’Anna School of Advanced Studies and A. Gemelli University Polyclinic in Italy.

It is designed to enable patients to reach out for an object and recognise its shape, position, consistency and size without having to look at it. The device offers a subtle close-to-natural sense of touch, according to the team.

The researchers further noted that existing myoelectric prostheses facilitate voluntary motor control of an artificial limb through residual muscle function in the forearm, but lack sensory feedback.

Tested in multiple patients, the new bionic hand demonstrated stimulation of nerves in the amputee’s stump. These nerves provide real-time sensory feedback to the user.

EPFL School of Engineering bioengineering professor Silvestro Micera said: “Our study shows that sensory substitution based on intraneural stimulation can deliver both position feedback and tactile feedback simultaneously and in real time.

“The brain has no problem combining this information, and patients can process both types in real time with excellent results.”

The use of the new bionic hand involves the insertion of electrodes directly into the amputee’s stump. These electrodes send electric pulses that enable intraneural stimulation and restoration of the flow of external information.

Patients will need training to learn translation of the electric pulses into proprioceptive and tactile sensations.

When assessed, two amputees were able to regain high proprioceptive acuity, with results comparable to those in healthy subjects.

EPFL researcher and study lead author Edoardo D’Anna said: “These results show that amputees can effectively process tactile and position information received simultaneously via intraneural stimulation.”

The study has been published in Science Robotics.

BGN Technologies, the technology transfer company of Israel-based Ben-Gurion University (BGU), has unveiled a new artificial intelligence (AI) platform to monitor and predict the progression of neurodegenerative diseases.

Developed by professor Boaz Lerner at BGU’s Department of Industrial Engineering and Management, the platform is expected to enable the identification of markers for personalised patient care and improved drug development.

Initially, the platform will be used to track amyotrophic lateral sclerosis (ALS), with plans to expand its application to other neurodegenerative conditions, including Parkinson’s and Alzheimer’s diseases.

Complicated research and drug development for ALS is attributed to the heterogeneity of the patient population that results in variability in onset symptoms, disease progression rate and pattern, and survival.

BGN Technologies said that the new platform will improve care and quality of life for ALS patients through reliable stratification to homogenous sub-groups, and personalised prediction of disease progression rate and pattern.

The platform will utilise machine learning and data mining algorithms to analyse demographic and clinical data in order to generate models for predicting the rate and pattern of ALS progression.

These models can also be used to identify factors required for the prediction and stratify homogenous sub-groups from the heterogeneous ALS population.

In addition, the platform is expected to improve clinical trials design and the clinical evaluation of treatment by identifying markers of different sub-populations for which treatment is beneficial, in turn enhancing success rates of studies.

Lerner said: “The novel platform, which uses machine learning algorithms, will enable not only accurate prediction of disease progression, a crucial ingredient for better clinical trials, but also identification of interrelationships between demographics and measurable factors from physical examinations and patient functionality that will advance clinical research of this devastating condition.”

BGN Technologies intends to use recent funds from the Israel Innovation Authority to develop a system that will enable implementation of the new technology on PCs, the cloud and cellular applications.

Philips has unveiled its new Zenition mobile C-arm imaging platform, which can provide live image guidance during surgical procedures.

Based on X-ray technology, Zenition features image capture and image processing capabilities similar to the company’s image-guided therapy platform Azurion, which was introduced in 2017.

The new imaging platform is intended to aid hospitals in maximising operating room (OR) performance and boosting clinical capabilities.

In addition, the Zenition mobile C-arm can be moved easily between operating rooms. It is simple to position around the patient and allows intuitive operability.

Philips Image Guided Therapy Systems business leader Ronald Tabaksblat said: “As patient numbers rise and procedures become more complex, equipment up-time, utilisation and usability become ever more important.

“Our new harmonised Zenition mobile C-arm platform offers the proven performance and ease of use needed for surgical teams to work with confidence and precision, now and in the future.”

The health technology company added that the new device supports increased OR performance across the healthcare facility.

Philips Zenition is said to enable fast and intuitive point-and-shoot image capture during any type of interventional or surgical procedure, including orthopaedic, trauma and vascular procedures.

The platform’s Position Memory feature and BodySmart software are said to capture fast and consistent images. The capability is applicable even at the edge of the image intensifier or flat detector, which minimises the need for C-arm repositioning by 45%.

It also incorporates MetalSmart software that automatically adjusts the images’ contrast and brightness in order to improve quality during the presence of metal objects such as implants in the field of view.

Zenition mobile C-arm imaging platform holds the European CE-Mark and the US Food and Drug Administration (FDA) 510(k) clearance.

The device will be commercially available in the US, Germany, Austria and Switzerland in the first half of this year. The company intends to expand it to additional markets in the future.