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The European Medical Device Regulation has formally replaced the Medical Device Directive, imposing a new set of requirements on the marketing of medical devices in the EU that will significantly alter the way that manufacturers organise and approach translations for product packaging. We hear from Professor Dr Herman Pieterse to find out how the new system will impact packaging and labelling requirements in Europe, and what companies can do to prepare for compliance.

With machine learning primed to break into the mainstream over the next few years, we take a look at the latest studies and technological developments helping to make a name for AI in the medical field, and find out how Cyberdyne’s Hybrid Assistive Limb exoskeleton will fit into the market for rehabilitation devices in the US. Plus, ALE healthcare division leader Nicole Hill explains how healthcare providers can prepare for the second wave of digitisation, with technology now involved in every step of the patient journey

As always, we also round up the latest news from the medical device industry, and get comment and analysis from GlobalData’s healthcare analysts on market dynamics, product innovation, regional developments and regulatory issues.

In this issue

The FDA turns its focus to medical device cybersecurity

As technology advances, global healthcare services are becoming increasingly digitised and connected to the internet, which allows for superior integration between services, devices, caregivers, and patients.
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How can technology influence the patient-physician relationship?
The advancement of technology within healthcare has not only drastically improved the health of populations through innovative treatment and efficiency of care, but has also contributed to the shift in the dynamics of the patient-physician relationship.
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Neurolife: a brain implant that may circumvent paralysis
Millions of people worldwide suffer from diseases that lead to paralysis. Research in neural prosthetic devices has substantially grown over the past few years to combat this condition. NeuroLife is an experimental device that aims to treat paralysis by creating an artificial link between the brain and the body.
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Is artificial intelligence the future of drug discovery?
For many pharmaceutical companies, machine learning is the most important aspect of AI, with the potential to allow machines to ultimately surpass the intelligence levels of humans.
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What can AI bring to healthcare and medical research?
Artificial intelligence (AI) and machine learning (ML) continues to be in the spotlight in the healthcare industry, with a number of transformational applications of AI and ML in different sectors of healthcare industry being recently announced.
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Learning together: tetraplegic humans work with machines to win race
One of modern medicine’s proudest triumphs is its ability to decipher the electrical patterns generated by neurones firing in the brain and translate them into tangible thoughts or desires. As a result, brain computer interfaces (BCIs) have become increasingly prevalent in clinic and research settings since the 1970s.
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New liver transplantation technology being used in hospitals
A hospital has become the first in the UK to start using a perfusion machine routinely before liver transplantation. The perfusion machine maintains the liver in a physiological state, keeping it warm and pumping it with blood, nutrients and, if required, medicine.
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EU medical device regulation: manufacturers’ responsibilities
From device tracking to local label translations, the demands on device companies are considerable and must be taken seriously, warns Professor Dr Herman Pieterse of the University of Ghent and Profess Medical Consultancy.
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Tech watch: machine learning in healthcare
From modelling disease risk to helping with diagnosis, artificial intelligence is starting to make itself felt in the medical field. Abi Millar looks at the latest studies and technological developments.
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One small step for man: meet HAL, the Japanese cyborg medical exoskeleton helping US patients walk again
Cyberdyne is bringing its Hybrid Assistive Limb (HAL) exoskeleton, designed to rehabilitate patients who have lower limb disorders, to the US market under a new partnership with Brooks Rehabilitation and the Brooks Cybernic Treatment Center of Jacksonville, Florida. Elliot Gardner takes a look at the technology, which has been in use in Japan since 2011, and finds out how it will fit into the market for rehabilitation devices in the US.
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Optimising the care pathway: a vision of connected healthcare delivery
Healthcare is entering a second wave of digitisation, which moves beyond electronic medical records with technology that touches every step of the patient journey. Nicole Hill, leader of the healthcare division at global networking and communications provider ALE, explains why now is the time to capitalise on this by creating a strategy for the digital transformation of healthcare providers.
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Next issue preview

Researchers at MIT have created a new in vivo networking system that can wirelessly power and communicate with medical devices inside the body. We speak to the team to find out how eliminating the need for batteries in devices opens up new opportunities.

Also in this issue, we sit down with remote pre-hospital and emergency care systems developer, Remote Diagnostic Technologies, to discuss the future of communications tech in emergency care following the company’s acquisition by health-tech giant Royal Philips.

Plus, we speak to Dr Maria Daniela Angione of Trinity College Dublin to find out more about the development of a disposable electronic chip made from a molecularly-engineered biopolymeric material, which is said to be suitable for use in remote, low-income settings, and explore the fast-growing medical technology sector in Costa Rica, where medical devices have overtaken the agricultural industry to become the country’s biggest export.

Finally, we round up the latest news from the medical device industry, and get comment and analysis from GlobalData’s healthcare analysts on market dynamics, product innovation, regional developments and regulatory issues.