The new Medical Device Regulations (MDRs) become enforceable May 2022. After that, all new devices set for market in the European market will have to demonstrate compliance with ISO 10993, even if the device has been on the market for years.

Computational modeling is an important supplement to physical testing and clinical trials for design and performance validation of medical devices. The Food and Drug Administration’s (FDA) guidance material, “Reporting of Computational Modeling Studies in Medical Device Submissions”, includes guidelines for providing statistical proof and validation of simulation results such as inclusion of “the sensitivity of the QOI(s) [quantity of interest] on key parameters and provide a systematic analysis of the uncertainty in relation to the key parameters, as appropriate” (FDA Guidance Section 10a, 2016).

New research finds that robotic arm rehabilitation in chronic stroke patients with aphasia, the loss of ability to understand or express speech, may promote speech and language function recovery.

Robotic arm rehabilitation is a commonly used intervention for treating impaired motor function in the arm, wrist, or shoulder subsequent to stroke. The robotic arm rehabilitation in this study targeted the right arm, as the participants had each suffered a left hemisphere stroke leading to a deficit in motor function on their right side. Individuals with left hemisphere strokes affecting motor function are also likely to have deficits in speech and language processing, and the present study investigated whether those individuals may improve in their speech and language performance following treatment aimed at the domain of motor function. The research team observed small but consistent improvement on measures assessing speech articulation and overall language processing in aphasia.

Researchers studied eight gait parameters in order to come up with a very sophisticated software program that uses an avatar to predict how much energy people use when they walk depending on their walking style. The software could be used to design exoskeletons or custom prosthetics.

The avatar — a torso equipped with two legs with feet — can be freely configured. Users start by entering their height and weight and can then set the walking speed, distance between their feet (stride length and stride width), and foot lift, along with the incline of both the torso and the ground. They can also add mass and simulate the effect of being pushed or pulled at different parts of the body. The number of calories burned and the energy consumption are displayed in real time whenever the parameters are modified.

Think of it as mathematics with a bite: Researchers at CU Boulder have uncovered the statistical rules that govern how gigantic colonies of fire ants form bridges, ladders and floating rafts. The findings may also help researchers explore designs for new dynamic networks, including molecular machines that deliver drugs directly to cells.

The research takes a unique look at one of the strangest, and potentially painful, networks in nature. Fire ants (Solenopsis invicta) are resourceful builders, using their own bodies to create gigantic structures made up of hundreds to thousands of insects and more.

A robot could become the weapon of choice for detecting and treating the most common cancer in men, improving results and reducing side effects. Scientists and mathematicians are working on a potentially game-changing way of improving the accuracy of both prostate cancer biopsies and of brachytherapy, which is used to treat some prostate cancers.

The five-year £3.3m EU-funded project brings together robot-design experts in France, a steerable flexible needle designed in the Netherlands, and a system guided by artificial intelligence and mathematical modelling by UK experts at the University of Portsmouth, working with medics and Clinical Scientists at Queen Alexandra Hospital, Portsmouth.

The constant movement of fish that seems random is actually precisely deployed to provide them at any moment with the best sensory feedback they need any to navigate the world, researchers found. The finding enhances our understanding of active sensing behaviors performed by all animals including humans, such as whisking, touching and sniffing, and demonstrates how robots built with better sensors could interact with their environment smarter and more effectively.

For humans, active sensing is when we feel around in the dark for the bathroom light switch, or when we bobble an object up and down in our hands to figure out how much it weighs. We do these things almost unconsciously, and scientists have known little about how and why we adjust our movements according the sensory feedback we get from them.

Researchers have reported that chemically coated ceramic implants successfully guided the regrowth of missing bone in lab animals while steadily dissolving. Surgeons and scientists at NYU School of Medicine and NYU College of Dentistry say their implanted scaffolds were naturally absorbed by the test animals' bodies as new bone gradually replaced the devices.

An international team of researchers have developed a low-cost sensor made from semiconducting plastic that can be used to diagnose or monitor a wide range of health conditions, such as surgical complications or neurodegenerative diseases.

An invention by a team of researchers from the National University of Singapore (NUS) holds promise for a faster, cheaper way to diagnose diseases with high accuracy. Professor Zhang Yong from the Department of Biomedical Engineering at the NUS Faculty of Engineering and his team have developed a tiny microfluidic chip that could effectively detect minute amounts of biomolecules without the need for complex lab equipment.