Aligning AI Innovation with EU Regulation

Artificial intelligence is revolutionising healthcare, from image analysis to design. For manufacturers competing in the global market, the main challenges for any device are building the technology itself, and the approvals process. In the European Union, this has meant making sure devices were MDR (medical device regulations) compliant. The EU Artificial Intelligence Act 2024/1689 adds an additional layer of regulation. While the MDR addresses clinical safety and effectiveness, the purpose of the AI Act is to allow the development of trustworthy AI while simultaneously ensuring the health, safety, and fundamental rights of people across the European Union.

An Anti-Cancer “GPS” System

The development of custom proteins for therapeutic use has just taken a giant step forward.

In 2024, half of the Nobel Prize in Chemistry went to Google DeepMind researchers John Jumper and Demis Hassabis, for their creation of AlphaFold. AlphaFold, an AI program, successfully predicted a protein’s shape and function from its chemical sequence.The other half of the prize went to David Baker of the University of Washington for solving the opposite problem: starting with the desired function of a protein, and deriving the amino acid sequence that would fold up into a molecule capable of performing that function.

Engineering Surface Patterns to Combat Infection

In a time when bacterial resistance to current antibiotics is rising, medical science needs all the new tools it can fit into its infection-fighting toolbox. In addition to new antimicrobial drugs, and repurposing older drugs to fight bacteria, new technologies are under development that may be able to stop infection without any drugs whatsoever.

Researchers at the University of Nottingham have come up with a way to halt, and even prevent infections on plastic medical devices, which relies on alterations to the surface of the plastic itself. Their research could not only help to prevent infection through medical devices, but could also lead to technologies that help the body to eliminate bacteria before infections take hold.

Perceptualized Date

“Humans possess more than one sense,” says Lutz Bornmann of the Max Planck Society in Germany, in his article The Sound of Science, “and there is no biological reason not to use the other ones.” When he puts it that way, it sounds quite reasonable. Much of western culture is geared toward visual representation of data–in images and text–but humans also have a highly evolved and very sophisticated system of auditory processing. Could we not also represent data through sound? 

Next-Generation Hearing Technology

Cochlear implants have been life-changing for many people with severe hearing loss. But cochlear implants have a number of limitations, and they don’t work for all types of hearing loss, for example when the cochlear nerve isn’t functional, as can be the case for patients with Neurofibromatosis type 2, cochlear ossification, certain types of head trauma, and other conditions. Auditory brainstem implants could offer an alternative to people for whom cochlear implants aren’t an option. 

Printing Tissue

Scientists at the Feinberg Lab at Carnegie Mellon University have created the first collagen-based microphysiologic system using FRESH 3D bioprinting. 

Traditional human tissue models, such as organ-on-chip devices, are restricted by available manufacturing techniques. They are made from silicone rubber, plastics, or other synthetic materials. As a result, they’re unable to fully replicate natural tissue environments, so their effectiveness is limited.

FDA Issues 3p510K Guidance

On November 21, 2024, the US Food and Drug Administration (FDA) published its final guidance for manufacturers seeking to authorize low-to-medium risk devices through the Third Party 510K (3P510K) Review Program. The program uses qualified third parties to conduct initial reviews of 510K device submissions. The FDA’s guidance also describes the use of third party review organizations for Emergency Use Authorization (EUA) requests.

Assistive Tech’s Rapid Growth

Between 2024 and 2025, the market value for assistive technologies grew from $2.9 billion to $4.97 billion. This figure is projected to grow to $30.9 billion by 2033. The growth is being driven by an aging population, increasing numbers of disabilities, and technological development. The United States leads the growth in demand, comprising 35 percent of the market, and of this, mobility devices–wheelchairs and walking aids–make up 40 percent. But in addition to mobility assistance, there are some exciting new advancements in products addressing other needs, including sensory assistance–hearing, sight, and even touch–exoskeletons, neural network grafts, and more.

Unveiling Secrets of the Universe

The Vera Rubin Observatory is set to begin its first mission: to scan the skies for cosmic events and objects. Its enormous camera will enable scientists to investigate cosmic phenomena on a scale–and at a resolution–previously unseen. Three particular phenomena of interest to the Observatory will be dark matter, dark energy, and Type Ia supernovae. For the next ten years, the Observatory will perform regular scans of the skies, looking for these and other objects and events. The Rubin Observatory plans to begin its survey, the Legacy Survey of Space and Time, in late 2025, and will release its first data set 12 to 14 months later.

Revolutionizing Health and Wellness with Tech

The 2025 Consumer Electronics Show, which ran from 7-10 January, introduced a wealth of new and exciting innovations, especially in the field of health and fitness technology. And yes, AI is in everything. Well, almost everything.

Complimentary Tools to Traditional Therapy

Smartphone apps aimed at supporting mental health are nothing new. Users looking for mood tracking apps, affirmations delivered by smartphone, digitally guided mindfulness and meditation, and virtual therapist sessions have plenty of options. However, until now, there have been no apps approved by the FDA as treatment for mental health conditions. The approval of the Rejoyn app as a treatment for depression is an exciting development, as it could help to increase the effectiveness of traditional talk and medication therapy. In addition, it could help to pave the way for cheaper, more accessible mental health care via smartphone.

A New Era in Insulin Delivery

The first insulin pump, the Biostator, was created in 1974. Continuous subcutaneous insulin infusion (CSII) devices have come a long way from that clunky bedside model. Many of today’s pumps can fit in the palm of the hand. Until recently, however, all of these devices were appropriate only for the treatment of Type 1 Diabetes. Insulin pump technology for Type 2 Diabetes had remained elusive. However, the FDA has recently cleared the very first automated insulin pump for adults with Type 2 diabetes, Insulet’s Omnipod system.

Sustainable Approach to Manufacturing

Green engineering means designing products for sustainable manufacture and use. That is, reducing waste and pollution during manufacture, promoting sustainability throughout the product’s life cycle, and minimizing the impact on both the environment and human health without sacrificing either efficiency or economic viability. The Sandestin Declaration of 2003 laid out the general principles of green engineering as:

Revolutions in OECTs

Organic electrochemical transistors (OECTs) have shown promise for different healthcare applications, from bioelectronics to biosensors and wearables. However current OECTs are subject to certain limitations, notably slow switching speeds and low temporal and operational stability. Studies are showing that a different architecture may be able to overcome some of these limitations. And this could be great news for medical applications.

How Materials are Shaping Medical Innovation

From e-skin that doesn’t lose sensitivity when it stretches, to a new substrate for implantable tech, materials science is breaking new ground every day. Here are eight recent developments in materials science that are paving the way for innovation in medical technology.

The Union of Engineering & Medicine

The union of engineering and medicine is creating new opportunities for innovations in human health. A recent study published in the Open Journal of Engineering in Medicine and Biology identifies several research areas in which biomedical engineering is poised to impact both engineering and medicine. These include: precision medicine, immuno-engineering,  the engineering of cells and genomes, developing systems for human function augmentation, and “Exo-Brain,” that is, engineering the brain, including with AI.

Is the Future of Phlebotomy Robotic?

The first use of robots in surgery took place in 1984, when a team at the University of British Columbia Hospital in Vancouver used the voice-operated “Arthrobot” to assist with positioning a patient’s leg for orthopedic surgery. Over the next year, robots assisted with 60 more surgeries at that hospital. Since then, the use of surgical robots, and the diversity of their tasks, have grown exponentially and with great success.

Relieving Cognitive Burdens

Optimizing tools and technology for the user's physical needs has long been a concern in the workplace. In addition to increasing safety and comfort, ergonomic design aims to increase efficiency and productivity and reduce error. As technology advances and the cognitive load of work increases, optimizing the workplace for users’ cognitive needs is increasingly important. This is especially true in the medical field, where the needs of service providers, recipients, and institutions must be considered and where avoidable error on any side can cost lives.

Creating System Harmony

As IoT and smart technologies continue to develop, cyber-physical systems, which integrate computational components with physical processes, are paving the way for unprecedented innovation in industries such as manufacturing, transportation, and healthcare, to name a few. These systems integrate sensing, actuation, computation, and communications capabilities to interact with the physical world, leveraging these to improve the overall performance, reliability, and safety of the physical systems.

Challenges exist, of course, including security, hardware lead times, and the necessity of changing corporate communication and structure. However, in terms of productivity, scalability, and efficiency, the investment is already bearing fruit.

A Changing Task Environment

A study from the University of Zurich reports that developers use an average of 16 tools in the course of their day, and spend their time switching between a wide variety of tasks. The resulting complexity can be exhausting for individuals and can result in inefficiency for the organization. Amanda Silver, general manager for Microsoft’s platform engineering team, believes that platform engineering can improve the developer experience and optimize the software development lifecycle.
 
Platform engineering is already becoming crucial to IT development. According to one report, more than 80 percent of developers spend less than 30 percent of their time writing code–and sometimes as little as 12.5 percent. It’s estimated that by 2026, 80 percent of software engineering companies could be using platform teams as internal contributors for tools for application technology, reusable services, components, and more.