Global Breakthrough: FGC2.3 Feline Vocalization Project Nears Record Reads — Over 14,000 Scientists Engage With Cat-Human Translation Research

Global Breakthrough: FGC2.3 Feline Vocalization Project Nears Record Reads — Over 14,000 Scientists Engage With Cat-Human Translation Research

MIAMI, FL — The FGC2.3: Feline Vocalization Classification and Cat Translation Project, authored by Dr. Vladislav Reznikov, has crossed a critical scientific milestone — surpassing 14,000 reads on ResearchGate and rapidly climbing toward record-setting levels in the field of animal communication and artificial intelligence. This pioneering work aims to develop the world’s first scientifically grounded…

Tariff-Free Relocation to the US

Tariff-Free Relocation to the US

EU, China, and more are now in the crosshairs. How’s next? It’s time to act. The Trump administration has announced sweeping tariff hikes, as high as 50%, on imports from the European Union, China, and other major markets. Affected industries? Pharmaceuticals, Biotech, Medical Devices, IVD, and Food Supplements — core sectors now facing crippling costs,…

Global Distribution of the NRAs Maturity Levels as of the WHO Global Benchmarking Tool and the ICH data

Global Distribution of the NRAs Maturity Levels as of the WHO Global Benchmarking Tool and the ICH data

This study presents the GDP Matrix by Dr. Vlad Reznikov, a bubble chart designed to clarify the complex relationships between GDP, PPP, and population data by categorizing countries into four quadrants—ROCKSTARS, HONEYBEES, MAVERICKS, and UNDERDOGS depending on National Regulatory Authorities (NRAs) Maturity Level (ML) of the regulatory affairs requirements for healthcare products. Find more details…

This Brain-Computer Interaction Has Transformed into a Bidirectional Channel

This Brain-Computer Interaction Has Transformed into a Bidirectional Channel

For years, researchers have been exploring how sensors can detect brain activity and use this data to give paralyzed patients control over their bodies. But that technical challenge is only half of the problem: People also need to receive tactile feedback from their environment in order to achieve desired tasks. Without this feedback, a task as simple as drinking from a cup can be impossible.

Chad Bouton, the vice president of advanced engineering at Feinstein Institutes for Medical Research in Manhasset, New York, leads a team of researchers that has been working on brain-computer interface technology for years. One of their early studies focused on sensing impulses from the brain, which were decoded to drive electrical impulses that enabled a paralyzed patient to move his arm just by thinking about it.

That 2015 study involved the creation of a “neural bypass” using a single chip that contained an array of electrodes, which was then implanted in the motor cortex of the patient’s brain. The neural activity of his brain was detected by this sensor, and an AI model interpreted the intended movements that these signals represented.

Bouton’s team has made great strides in the ensuing 10 years. Their most recent project is the creation of a “double neural bypass.” Instead of simply reading the brain signals of the intended movement, they added a second channel that stimulated the part of the brain that senses touch. To accomplish this, they implanted a total of five chips in the brain of Keith Thomas, a patient who was paralyzed from the chest down after a diving accident. Two electrode arrays were implanted into the motor cortex; the additional electrodes provide more data for the system to analyze about the subject’s intended movements. The team also implanted three additional chips into the patient’s somatosensory cortex—the part of the brain that processes touch. In total, 224 electrodes were implanted in Thomas’ brain.

The researchers then trained an AI model to process Thomas’ brain signals and control his hand. Information from the motor cortex is “decoded” by the AI and then used to stimulate an electrode array on the patient’s neck to modulate his spinal cord. He also was fitted with electrode patches on his forearm to stimulate muscles that control his hand movements.

Advances in Brain-Computer Interfaces

Initially, Thomas was only able to lift his arm about an inch off his wheelchair. After receiving spinal cord stimulation through the patch on his neck, he now has developed enough arm strength that he can lift his hand and wipe his face without assistance.

A man in a wheelchair holding and drinking from a cup with the assistance of sensors connected to his arm and brain.
Keith Thomas, who has lived with paralysis since a diving accident in 2020, lifts and drinks from a cup on his own.Feinstein Institutes

Meanwhile, tiny sensors applied to Thomas’ fingers and palms send touch and pressure data back to the computer, which then stimulates appropriate parts of his somatosensory cortex, leading to the sensation of touch. This feedback has resulted in his ability to “feel” with his hand and use those sensations during his movements. Thomas “can now pick up an empty eggshell without cracking it,” says Bouton.

Thomas is also able to pick up a cup and drink from it, just by thinking about performing this task. What’s more, he can sense touch in his forearm and wrist, even when he is not connected to the neural bypass system. It’s not clear what physical mechanism is at work that made this happen—for example, it could be an instance of neuroplasticity forming new connections with nerves and the brain.

According to Bouton, “it is known from animal experiments electrical stimulation can promote neuronal growth, but here it is unclear whether it’s more about strengthening spared connections at the spinal cord injury site. Right now, we just know the results are significant and leading to functional and meaningful outcomes.”

With these promising results, double neural bypass systems could be a potential treatment to help other patients with spinal cord injuries, as well as other conditions such as stroke, Parkinson’s disease, or traumatic brain injury.

Minuscule Pacemaker Disintegrates After Its Usefulness Is Over

Minuscule Pacemaker Disintegrates After Its Usefulness Is Over

The world’s tiniest known pacemaker, a device smaller than a grain of rice, can be implanted using minimally invasive techniques and dissolves when no longer needed. Researchers described their invention today in the journal Nature.

Pacemakers are implantable devices that electrically stimulate cardiac muscles to control heart rates. Many patients require temporary pacemakers for short-term heart problems, such as slow heart rates during recovery from cardiac surgery.

Conventional temporary pacemakers require invasive surgeries to implant them and then remove the devices. These procedures pose significant risks, such as infection or damage to heart muscles. Such complications are why Neil Armstrong died. He received a temporary pacemaker after a bypass surgery, but when the wires were removed he experienced fatal internal bleeding, says Igor Efimov, a professor of biomedical engineering and cardiology at Northwestern University, in Chicago.

To avoid problems resulting from pacemaker removals, Efimov and his colleagues developed the first dissolvable pacemaker in 2021. Although this quarter-size device performed well in animal experiments, cardiac surgeons asked if it was possible to further miniaturize such pacemakers for pediatric use.

“We were motivated by an unmet need: children born with congenital heart defects,” Efimov says.

Roughly 1 percent of children are born with congenital heart defects, Efimov explains. After surgeries treating such defects, children generally only need temporary pacemakers, as their hearts usually repair themselves after seven days or so. The goal was to make a temporary pacemaker that was as tiny as possible for the small, fragile hearts of newborns, Efimov says.

How the Tiny Dissolving Pacemaker Works

The new 13.8-milligram pacemaker is just 1.8 by 3.5 by 1 millimeter in size, capable of fitting inside the tip of a syringe. In their experiments, the researchers could implant it with an injection through a skin incision less than 3 mm wide.

“The small size of the pacemaker is without precedent,” Efimov says.

The quarter-sized pacemaker from 2021 was powered with the help of a built-in antenna that limited attempts at further miniaturization. In contrast, the new device has electrodes that when exposed to body fluids generate an electrical current. This design eliminates the need for an external power source, wires leading out of the body, and an antenna.

The new device is biodegradable, dissolving and being absorbed by the body after its useful lifetime—no surgical removal is required. The new pacemaker also does not interfere with magnetic resonance imaging and computed tomography scans, which is of benefit for patients who require routine medical imaging.

The researchers paired the new pacemaker with a small, soft, flexible, wearable patch that sits on a patient’s chest. When this patch detects an irregular heartbeat, it automatically emits pulses of near-infrared light. These shine through a patient’s skin, breastbone, and muscles to wirelessly control the pacemaker, flashing on and off at a rate that corresponds to the desired heart rate.

In experiments, the scientists found their new pacemakers proved effective in small and large animals such as mice, rats, dogs, and pigs, as well as human hearts from organ donors. Despite its size, it delivered as much stimulation as a full-size pacemaker.

The pacemakers are so tiny that the researchers could safely deploy arrays of multiple devices across the heart. This setup could enable more-complex stimulation of multiple areas of the heart to restore a regular heartbeat. The scientists add that they could also incorporate the new pacemakers into other medical devices, such as heart-valve replacements to help cardiologists address complications that might occur during a patient’s recovery.

The researchers note that these small biodegradable implants might have a number of uses beyond the heart. For instance, they say the devices could find use as electrical stimulators used in nerve and bone regeneration, wound therapy, and pain management.

Intricate Haptic Feedback: Experience a Pinch, Stretch, or Tap Sensation

Intricate Haptic Feedback: Experience a Pinch, Stretch, or Tap Sensation

Most haptic interfaces today are limited to simple vibrations. While visual displays and audio systems have continued to progress, those using our sense of touch have largely stagnated. Now, researchers have developed a haptics system that creates more complex tactile feedback. Beyond just buzzing, the device simulates sensations like pinching, stretching, and tapping for a more realistic experience.

“The sensation of touch is the most personal connection that you can have with another individual,” says John Rogers, a professor at Northwestern University in Evanston, Ill., who led the project. “It’s really important, but it’s much more difficult than audio or video.”

Co-led by Rogers and Yonggang Huang, also a professor at Northwestern, the work is largely geared toward medical applications. But the technology could be used in a wide range of uses, including virtual or augmented reality and the ability to feel the texture of clothing fabric or other items while shopping online. The research was published in the journal Science on 27 March.

A Nuanced Sense of Touch

Today’s haptic interfaces mostly rely on vibrating actuators, which are fairly simple to construct. “It’s a great place to start,” says Rogers. But going beyond vibration could help add the vibrancy of real-world interactions to the technology, he adds.

These types of interactions require more-sophisticated mechanical forces, which include a combination of both normal forces directed perpendicular to the skin’s surface and shear forces directed parallel to the skin. Whether through vibration or applying pressure, forces directed vertically into the skin have been the main focus of haptic designs, according to Rogers. But these don’t fully engage the many receptors embedded in our skin.

The researchers aimed to build an actuator that offers full freedom of motion, which they achieved with “very old physics,” Rogers says—namely, electromagnetism. The basic design of the device consists of three nested copper coils and a small magnet. Running current through the coils generates a magnetic field that then moves the magnet, which delivers force to the skin.

“What we’ve put together is an engineering embodiment [of the physics] that provides a very compact force delivery system and offers full programmability in direction, amplitude, and temporal characteristics,” says Rogers. For a more elaborate setup, the researchers also developed a version that uses a collection of four magnets with different orientations of north and south poles. This creates even more complex sensations of pinching, stretching, and twisting.

Haptics at Your Fingertips—or Anywhere

Hand wearing finger splints and wrist support against a plain background.
Because fingertips are highly sensitive, only small forces are needed for this application. John A. Rogers/Northwestern University

Although much of the previous work in haptics has focused on fingertips and the hands, these devices could be placed elsewhere on the body, including the back, chest, or arms. However, these applications may have different requirements. Compared with places like the back, the fingertips are highly sensitive—both in terms of the force needed and the spatial density of receptors.

“The fingertips are probably the most challenging in terms of density, but they’re easiest in terms of the forces that you need to deliver,” says Rogers. In other use cases, delivering enough power may be a challenge, he acknowledges.

The force possible may also be limited by the size of the coils, says Gregory Gerling, a systems engineering professor at the University of Virginia and former chair of the IEEE Technical Committee on Haptics. The coil size dictates how much force you can generate, and at a certain point, the device won’t be wearable. However, he believes it is sufficient for VR applications.

Gerling, an IEEE senior member, finds the use of magnetism in multiple directions interesting. Compared with other approaches that are based on hydraulics or air pressure, this system doesn’t require pumping fluids or gases. “You can be kind of untethered,” Gerling says. “Overall, it’s a very interesting, novel device, and maybe it takes the field in a slightly new direction.”

Applications in VR, Neuropathy, and More

The clearest application of the device is probably in virtual or augmented reality, says Rogers. These environments now have highly sophisticated audio and video inputs, “but the tactile component of that experience is still a work in progress,” he says.

Their lab, however, is primarily focused on medical applications, including sensory substitution for patients who have lost sensation in a part of the body. A complex haptics interface could reproduce the sensation in another part of the body.

For example, nerve damage in people with diabetic neuropathy makes it difficult for them to walk without looking at their feet. The lab is experimenting with placing an array of pressure sensors into the base of these patients’ shoes, then reproducing the pattern of pressure using a haptic array mounted on their upper thighs, where they still have sensation. The researchers are working with a rehabilitation facility in Chicago to test the approach, mainly with this population.

Continuing to develop these medical applications will be a focus moving forward, says Rogers. In terms of engineering, he would like to further miniaturize the actuators to make dense arrays possible in regions of the body like the fingertips.

Feeling the Music

Additionally, the researchers explored the possibility of using the device to increase engagement in musical performances. Apart from perhaps feeling vibrations of the bass line, performances usually rely on sight and sound. Adding a tactile element could make for a more immersive experience, or help people with hearing impairment engage with the music.

With the current tech, basic vibrating actuators can change the frequency of vibration to match the notes being played. While this can convey a simple melody, it lacks the richness of different instruments and musical components.

The researchers’ full-freedom-of-motion actuator can convey a more vibrant sound. Voice, guitar, and drums, for instance, can each be converted into a delivery mechanism for a particular force. Like with vibration alone, the frequency of each force can be modulated to match the music. The experiment was exploratory, Rogers says, but it exploits the advanced capabilities of the system.

105 Days Living with an Electromagnetic Heart

105 Days Living with an Electromagnetic Heart

Earlier this year, a man went shopping in Sydney with a new type of artificial heart buried in his chest. He was the first person to use the device outside of a hospital setting.

The company Bivacor announced last week that the Australian clinical-trial patient used its total artificial heart for a record 105 days before receiving a heart transplant in early March. The patient was also able to leave the hospital and stayed out for almost four weeks before being called back for transplantation surgery. None of the five U.S. patients who tried out a Bivacor heart last year had the device for longer than a month, and none left the hospital in that time.

Passing the 100-day milestone and the hospital discharge are meaningful firsts for Bivacor, though not unheard of in total artificial hearts. They are steps on a long journey to regulatory approval as a short-term life saver for patients awaiting transplantation, and perhaps eventually, as a long-term alternative to a donor organ.

“It’s a continuous process,” says Daniel Timms, founder and chief technology officer of Bivacor. “My analogy for that is the space program—we’re not going to Mars straightaway.”

How the Bivacor Artificial Heart Works

The Bivacor heart uses electromagnets to spin a core in a chamber that propels blood. This sets it apart from alternative devices, which generally have more potential physical failure points in their various valves, seals, and moving parts. Bivacor hopes this durability will prove out, with patients able to use the device for 10 to 20 years. Donor hearts are generally expected to last 10 years.

Bivacor engineers described the technology in greater detail for IEEE Spectrum in 2019. The device uses a single magnetically levitated rotor to pump blood to both the lungs and the body, replacing the function of both heart ventricles. With its one moving part levitating in a magnetic field, there’s no worry that friction and mechanical wear will cause the machine to give out.

Since 2019, says Timms, though no major technical details have changed, the team has been pleasantly surprised at how responsive the heart has been to changes in patient activity. They’ve also been satisfied by how naturalistic the artificial pulse has proven, even detectable by the standard techniques of fingers, pulse oximeter, and wrist cuff.

Some patients in advanced stages of heart failure require mechanical assistance pumping blood to the lungs and throughout the body. If only part of the heart is malfunctioning, they may receive a ventricular assist device, a small implanted pump that gives a boost to blood flow. But for complete heart failure, heart transplantation is currently the preferred long-term treatment. Total artificial hearts, such as the Bivacor device, are being used and investigated to serve as a “bridge to transplantation,” keeping patients alive for the days or months until suitable organs are found and keeping them healthy enough for transplantation.

Illustration of an artificial heart that has been successfully implanted in a patient's chest.
Bivacor’s artificial heart can replace a failing heart and keep a patient alive until transplant surgery. BiVACOR

The Need for Artificial Hearts

Around 5,000 heart transplants are performed every year globally, according to the International Society for Heart and Lung Transplantation, but there are 10 times as many people awaiting a donor organ at any given time.

“I am very optimistic that it will be extremely helpful for patients,” says Francisco Arabía, an artificial heart expert with Banner Health in Phoenix, a U.S. Bivacor trial site. “Now, compared to other [total artificial hearts], time will tell.” Another 15 patients are expected to take part in early feasibility and safety research in the United States, and a larger pivotal study would follow. That whole process could take three to five years, he says.

In the meantime, Timms highlights the bravery of trial participants, when device failure likely means death. “That’s an incredible leap of faith they’re taking,” says Timms.

In the United States, there is just one alternative total artificial heart that’s been approved by regulators, produced by SynCardia; its current device is a descendant of the first-ever artificial heart, the Jarvik 7 device, which was first implanted in a patient in 1982. SynCardia’s device is pneumatically powered, so users carry around a large and somewhat noisy pneumatic driver. Other total artificial hearts are also in development. For example, a Swedish company called Real Heart is seeking a humanitarian device exemption from U.S. regulators that would facilitate use of its total artificial heart, a lighter and quieter device with pumps powered by batteries.

For Timms, an Australian who began designing the Bivacor heart in his Ph.D. research more than 20 years ago, the first Australian patient also marks a significant return of the technology, which has traveled around the world with him in development. He was inspired to create the heart when his father, a plumber and a tinkerer, was diagnosed with heart failure. The two built the first prototype together in the family’s backyard shed.