Injectable Liquid Prosthesis to Treat Retinal Diseases Developed

Retinal prostheses promise the restoration of vision to people with age-related macular degeneration, retinitis pigmentosa, and other conditions that lead to the loss of functional photoreceptors. A number of technologies are already in existence that mimics the functionality of the retina by stimulating the inner retinal network, but most of these rely on wearable cameras, special glasses, computers, and wiring to interface with the eye. Moreover, the results are highly lacking and the achieved vision is extremely low resolution. At the IIT-Istituto Italiano di Tecnologia (Italian Institute of Technology), scientists have now come up with an injectable retinal prosthesis that does away with all the complexity and works directly to take over the function of diseased photoreceptors.

The new approach relies on photoactive polymeric nanoparticles that are one-hundredth of a diameter of human hair and behave like photovoltaic cells. These are suspended in a liquid and can be injected en masse under the retina. Once inside, they settle down and can then be used to electrically activate existing retinal neurons when light strikes the nanoparticles.

Photoactive nanoparticles (in red) cover a retinal neuron membrane (nucleus in blue). Credit: IIT-Istituto Italiano di Tecnologia (M. Bramini)

All this was already tried in laboratory rats with retinitis pigmentosa who were effectively blind before the injection of the liquid implant. Following, the nanoparticles were confirmed to have spread throughout the retina and did indeed function as desired, returning functional vision to the animals.

Because the approach involves a liquid substance that can be injected using existing methods, once validated it may be quickly adopted in practice to treat millions of people with lost vision.

“Our experimental results highlight the potential relevance of nanomaterials in the development of second-generation retinal prostheses to treat degenerative retinal blindness, and represents a major step forward,” said Fabio Benfenati, the lead researcher, in a press release. “The creation of a liquid artificial retinal implant has great potential to ensure the wide-field vision and high-resolution vision. Enclosing the photoactive polymers in particles that are smaller than the photoreceptors increases the active surface of interaction with the retinal neurons, and allows to easily cover the entire retinal surface and to scale the photoactivation at the level of a single photoreceptor.”

Via: Istituto Italiano di Tecnologia
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NASA Launches “Lunar Loo” Challenge to Design a Reduced Gravity Toilet

The National Aeronautics and Space Administration (NASA) has set an exciting, yet ambitious timeline to get us back to the moon by 2024! But instead of merely planting a flag, playing a round of golf, and collecting some rocks to bring home, NASA hopes to establish a permanent lunar base that will eventually act as the launching point for crewed missions to Mars.

If humans are to settle on the moon en route to exploring the “final frontier,” they’ll also need to figure out how to perform many tasks in reduced gravity that we terrestrials take for granted, such as using the loo. And so, to help mankind “go” where no man has gone before, NASA just launched the “Lunar Loo Challenge”.

Space toilet on the International Space Station (image credit: NASA)

Though space toilets already exist, they only work in microgravity (weightlessness), and they’re not the most efficient or appealing to use. So NASA is looking to the public to help design a better solution. According to the challenge overview:

NASA is looking for a next-generation device that is smaller, more efficient, and capable of working in both microgravity and lunar gravity.  Getting back to the Moon by 2024 is an ambitious goal, and NASA is already working on approaches to miniaturize and streamline the existing toilets.  But they are also inviting ideas from the global community, knowing that they will approach the problem with a mindset different from traditional aerospace engineering.  This challenge hopes to attract radically new and different approaches to the problem of human waste capture and containment.

Most of the requirements for the winning design are what you’d expect for a moon toilet: it must be able to operate in both lunar and microgravity with specific size, power consumption, and noise level restrictions, and be able to accommodate both males and females of various heights and weights. It must also be able to dispose not only bodily waste, but also female menses and toilet hygiene products. Somewhat humorously, the guidelines also state that “bonus points will be awarded to designs that can capture vomit without requiring the crew member to put his/her head in the toilet.” A suction mask that somehow prevents aspiration pneumonia would probably do the trick, so best of luck to whoever designs the appropriate valve!

If you’re interested in answering NASA’s call to help astronauts answer nature’s call, you can submit your ideas until August 17. The competition is open to anyone (even kids). Winners will be announced on September 30, and the top three winning ideas will share a $35,000 prize and be invited to talk more about their ideas with NASA engineers.

More information and entry form: NASA’s Lunar Loo Challenge
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Go-2 Spinal Stimulator Helps Return Leg Function: Interview with Jan Öhrström, Chairman of the Board, GTX Medical

GTX Medical, a MedTech company with offices in The Netherlands and Switzerland, has announced that it received Breakthrough Device Designation for the Go-2 system, an implant that provides targeted epidural spinal stimulation therapy for patients with spinal cord injuries. The device aims to allow such patients to regain leg motor function and neurological control.

At present, patients with lower-limb paralysis caused by traumatic spinal cord injuries have limited options in terms of regaining substantial functional recovery. The Go-2 systems aim to change this for patients with a sufficient number of remaining spinal nerve fibres. The device imparts electrical pulses to remaining nerve fibres that mimic motor impulses that occur during walking.

These impulses are synchronized with movements the patient makes in real-time and in effect, the device trains the brain to use the remaining nerve fibers to assist with walking. When used over time the device enables neural re-wiring which can result in long-term improvements in patient mobility.

GTX has also developed a non-invasive wearable system called LIFT for patients with upper limb paralysis after spinal cord injury. The LIFT device received FDA Breakthrough Device Designation in 2017.

Medgadget had the opportunity to talk to Jan Öhrström, Chairman of the Board at GTX Medical about this technology.

Conn Hastings, Medgadget: Please give us an overview of the current therapeutic options for people with spinal cord injuries and paralysis.

Jan Öhrström, GTX Medical: The initial therapeutic options after a spinal cord injury are focused on limiting the damage caused by a traumatic event as much as possible by stabilizing the individual, applying neuroprotective therapies, performing surgeries and considering the use of ventilation (more information can be found on the website of the Reeve Foundation). Rehabilitation following a traumatic spinal cord injury cannot start before the acute care phase is completed.

Most therapeutic options are focused on physical rehabilitation and occupational therapy with the aim to recover as much as possible and learning how to live with the condition. Functional goals are set during the rehabilitation program by a multi-disciplinary team of rehab physicians, physical therapists, occupational therapists, psychologists and social workers. Standard rehabilitation usually lasts between 3 and 12 months, depending on the type of injury and the reimbursement of rehabilitation in different geographies. Besides conventional rehabilitation exercises, a number of modern rehabilitation aids are available such as Functional Electrical Stimulation (FES), exoskeletons and gait training with body weight support systems, robotic treadmills, sometimes combined with virtual reality, etc. Once the rehabilitation ends, patients are encouraged to continue exercising to maintain the progress they have gained.

Medgadget: Is there a significant unmet therapeutic need for this patient population?

Jan Öhrström: The standard of care for people who suffer a spinal cord injury is rehabilitation. Initial recovery leading to the maximal extent recovery in the first months with conventional rehabilitation is sometimes enhanced with automated rehab tools. However, neither medical therapies, nor conventional devices like exoskeletons promotes much recovery for wheelchair-bound people. Hence, the message sent by healthcare providers is more about learning to live your life in your new condition rather than focusing on hope of recovery.

For decades, researchers have been searching for curative solutions. Stem cells may be an attractive option one day, but this is still far away from clinical applicability. Neurostimulation is the single breakthrough promoting functional recovery and bringing hope to patients living with spinal cord injury.

Medgadget: How do you anticipate that the Go-2 system will help to address these unmet needs?

Jan Öhrström: In incomplete spinal cord injuries, dormant fibers are still available in the spinal cord. By using targeted epidural spinal cord stimulation (TESS), these intact circuits located below the lesion can be reactivated. The electrical stimulation immediately enables voluntary control of paralyzed muscles during walking.

GTX specifically targets individuals who have sufficient remaining spinal nerve fibers and therefore have the best chance of walking again. Our unique approach with stimulation of the spinal cord focuses on training the brain to use the remaining nerves in the spinal cord to activate individual leg muscles. This method promotes the permanent and previously unimaginable recovery of leg control, leading to a patient’s physical, social and emotional rehabilitation.

While we intend for our therapy to work closely with rehabilitation, our goal is different: we intend for each patient to regain as much function as possible from our therapy, including walking without human assistance. We want them to retain and build on hope, since we offer a truly life-changing solution.

Medgadget: What types of benefits do you anticipate that the system might produce in terms of increased movement and power for patients with paralysis?

Jan Öhrström: Great improvements on the Functional Independence Measure scale have been observed for patients in the feasibility study, even though they had been paralyzed up to 14 years earlier (unpublished data). These improvements might be considered a miracle by those who understand the severity of this condition. The Functional Independence Measure (FIM – scale of 91 motor points) is a clinical test evaluating the amount of assistance required by a person with a disability to perform basic life activities, ranging from complete dependence to full independence. For example, a gain of 20 motor points readily translates to a €0.5M cost reduction per patient over the lifetime (Miller et al. 2016). On average, for each person with spinal cord injury, a €2M overall healthcare associated cost over a 25-year life span is due to decreased independence (bathing, toilet, to and from the bed, mobility inside and outside the house) and organ functions (bladder and bowel control).

Medgadget: How does Targeted Epidural Spinal Stimulation work?

Jan Öhrström: To implement TESS therapy, surgeons implant an electrode array to deliver electrical stimulation in the region controlling motor function. The array delivers precisely timed pulses to specific parts of the spinal cord. These pulses mimic the timing and location of the motor commands from the brain that drive walking. When the right foot is put down, for example, mild stimulation is provided to start raising the left leg in anticipation of taking the next step. When he/she feels the stimulation, the patient will be able to activate the leg muscles and make a step in a natural fashion. The patient always remains in control and will not have the feeling his body became some sort of robot.

It has been shown in early trials that this approach successfully trains the brain both to use the remaining healthy nerves spared by the injury as well as to actually grow new, functional nerve connections. Combined with rehabilitation, TESS therapy leads to recovery of neural pathways controlling movement, even without stimulation. Prof. Courtine published a demonstration of restoring locomotion after paralysis in Nature in 2018.

Over time, TESS promotes an anatomical reorganization of the spinal cord and residual neural pathways spared by the injury. The rewiring restores voluntary control over the legs, even when the stimulation is switched off. This approach enables long-term continuous training at home. This complements the patients’ rehabilitation sessions and helps them to both achieve independence while also improving their condition.

Medgadget: Please tell us about the latest FDA Breakthrough Device Designation and what this will mean for the Go-2 in terms of testing and the pathway to approval.

Jan Öhrström: The FDA Breakthrough Devices Program was established to help patients receive timely access to breakthrough technologies that provide a more effective treatment option compared to the current standard of care for life-threatening, or irreversibly debilitating diseases or conditions.

This Breakthrough Device Designation is an important regulatory milestone, accelerating the regulatory pathway to market approval. It underscores the transformative potential of the Go-2 system and the unmet medical need it addresses.

The designation provides GTX the opportunity to frequently interact with FDA regulatory experts, thereby gaining valuable advice during the premarket review phase, and to receiving a prioritized review of GTX’ submissions.

Medgadget: Please give us an overview of the noninvasive wearable LIFT system that is currently in development.

Jan Öhrström: LIFT is a transcutaneous and wearable stimulation therapy intended to improve hand- and arm function, independence and quality of life in people with tetraplegia after a spinal cord injury. GTX is carrying out further product development in advance of a pivotal Up-LIFT clinical trial in the USA.

Improvement in neuromuscular function is directly linked with an improvement in quality of life. Regaining the ability to hold a spoon or a cup results in increased independence and improved motor skills may allow individuals with a spinal cord injury to operate, for example, a computer.

GTX is developing the transcutaneous LIFT device for non-invasive electrical spinal cord stimulation (NESS) therapy to enable restoration of motor control and function in the upper limbs after spinal cord injury.

The LIFT stimulator delivers non-invasive and painless electrical pulses through a patented waveform to restore the communication between the brain and the spared neural networks below the injury.

Wearable gel electrodes are attached to the skin on the back of the patient’s neck (cervical spine) and controlled via a hand-held stimulator programmed with a tablet. The LIFT device has adjustable settings for current, frequency, waveform and duration of stimulation.

The scientific basis for development of the LIFT system is predicated upon research studies performed on animal and human subjects with spinal cord injury demonstrating residual (spared) sensory and motor pathways are critical in mediating the voluntary movements that are possible when NESS therapy is paired with task-based training by the individual.

The LIFT System is intended to be used at a rehabilitation therapy clinic, in the hospital and at home.

A pivotal study in the USA is planned for Q4 2020, to support an application for market clearance to the FDA in the USA by 2022.

Product info page: Targeted Epidural Spinal Stimulation (TESS)

Link: GTX Medical…

Flashback: Paralyzed People Walk Again, Even Without Neurostimulation
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Dexcom Moves Toward Diabetes Prevention With the G6 Pro System: An Exclusive Look

The introduction of the continuous glucose monitor (CGM) has been a game-changer in the field of diabetes management. For patients, CGMs drastically reduce the number of annoying and painful finger sticks needed to monitor blood glucose. With readings as often as every five minutes (or on-demand), patients can see trends in their glucose levels throughout the day and program alarms that will allow them to more rapidly intervene.

Up until now, the primary beneficiaries of CGMs have been those patients diagnosed with type I or II diabetes, as they require constant monitoring to ensure that blood glucose does not reach dangerously low or high levels. But as the prevalence of diabetes has continually been increasing, much is being invested into preventing diabetes, particularly type II diabetes and its precursor, prediabetes.

Last year, Dexcom announced the G6 Pro, which significantly increases the number of potential users who can benefit from a CGM. The new system, which is now available for pre-order, removes many of the barriers that patients who have not been been diagnosed with diabetes may have in embracing this innovative technology. At its minimum, the G6 Pro is simply a sensor and transmitter unit; up to 10 days of glucose readings are stored on the transmitter which is read and analyzed retrospectively in-clinic. This “blinded mode” may be appropriate for some (but not all) potential users without diabetes who may be more technologically hesitant. For those who have diabetes or benefit from seeing their glucose measurements and trends with alerts, the “unblinded mode” enables these features through the user’s smartphone.

Medgadget recently received a demo of the G6 Pro in our mailbox, but unlike the non-functional, Personal G6 system we looked at previously, our G6 Pro came straight from the factory, ready to wear and see if this editor needed to cut back on the cookies and spend more time on the treadmill!

Our experience kicked off with a virtual “visit” to the Dexcom clinical team who guided me through the sensor application process. Other than the “Pro” marking on the transmitter, everything up to this point was identical to the Personal G6. Inserting the sensor/transmitter was painless (literally) with the entire process only taking about a minute.

From here, the experience diverges, as patients who have not been diagnosed with diabetes will simply wear the sensor for up to 10 days in the “blinded mode” with no intervention; the glucose readings are collected and stored on the transmitter and downloaded later. Our demo kit included a G6 Pro Reader, which was basically a modified Personal touchscreen reader that is used only by clinics to verify that the sensor is working properly and to download the data after patients return to the clinic.

Some without diabetes, like this editor, as well as all patients who have been diagnosed with diabetes, will instead use the Pro system in an “unblinded mode”. After sensor insertion, they’ll pair their sensor/transmitter with their Android or iOS smartphone to receive their glucose readings. This experience is very similar to the Personal system; these patients can use the Dexcom app view trends and set alerts. The only real differences with the Pro system is that the transmitter isn’t reusable, and the patient must have a smartphone.

Our week with the CGM went uneventfully, and we were able to constantly view glucose trends and even ask Siri for the most recent measurement. After seven days, we converted our data into detailed reports using the Dexcom Clarity app and reviewed it with Dr. Daniel Katselnik, a San Antonio based endocrinologist and paid Dexcom spokesman. He shared to our relief that our glucose levels had been within normal ranges, so our junk food consumption, as excessive as it may have sometimes appeared, hadn’t yet led to prediabetes! We also asked Dr. Katselnik about how the G6 Pro might change his practice, and he shared that it would enable him to utilize a CGM on a wider variety of patients and hopefully stop the progression of diabetes earlier.

We wanted to know more about CGM’s role in diabetes prevention, so we also reached out to our friend Dr. David Ahn, an endocrinologist and Program Director at the Mary & Dick Allen Diabetes Center of Hoang Hospital in Newport Beach, California.

“I think diabetes prevention is a really compelling potential market for CGM, and I think the use case for pre-diabetes is definitely there,” said Ahn. “It can be a very fascinating education tool to help people see first-hand how their body is being affected, because most people can’t otherwise tell when their blood sugar is 180 vs 100.”

But Ahn shared that when it comes to healthy people using a CGM to ward off any risk factors for diabetes, it might still be too early to jump to conclusions.

“The data sets are going to be so different for someone with Type 1 diabetes compared to someone without any diabetes,” he said. “Perhaps down the road once we start seeing what CGM tracings look like in the non-diabetes population, we might be able to identify which patterns indicate early risk, but we honestly just don’t have that data yet.”

Moreover, while those with Type I diabetes benefit from wearing a CGM continuously, is around-the-clock monitoring beneficial or even financially feasible for those without?

“These questions are still being answered, but something like the G6 Pro at least offers flexibility, convenience, and a price point that allows these questions to finally be discussed,” said Ahn.

Overall, we think Dexcom has developed a promising product in the G6 Pro. It will certainly continue to help patients who currently have diabetes better manage their glucose levels. It will benefit those with early-diabetes by allowing them to see how their bodies are affected throughout the day and what lifestyle changes can be made. And perhaps for the rest of us, it could someday reveal some insights into the inner workings of the disease and how we can prevent it.

Promo video for the Dexcom G6 Pro:

More information: Dexcom Professional CGM

Flashbacks: Dexcom G6 Pro with Blinded Mode FDA Cleared; A Brief Look at Dexcom G6 Continuous Glucose Monitoring System; Dexcom G6 Continous Glucometer Going on Sale in Europe; Dexcom G6 Continuous Glucometer Doesn’t Require Finger Pricks
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Easily Removable Surgical Tape to Seal Internal Wounds

Researchers at MIT recently developed an adhesive tape that allows surgeons to seal internal wounds and that can readily stick to slippery internal surfaces, as a potential replacement for sutures. However, the adhesive worked a little too well and was difficult to remove or adjust without causing irritation or tissue damage.

Now, the research team has developed a new version of the tape that can be readily detached from the tissue surface by applying a liquid solution. The development makes the tape safer and easier to use, and allows surgeons to remove it once tissue healing has completed or adjust the tape’s position if required.

The tape is conceived as a replacement for internal sutures. “Our goal is to use bioadhesive technologies to replace sutures, which is a thousands-of-years-old wound closure technology without too much innovation,” said Xuanhe Zhao, an MIT researcher involved in the study. “Now we think we have a way to make the next innovation for wound closure.”

The original adhesive included polyacrylic acid and NHS esters, which form long-lasting bonds with the tissue surface. However, these bonds were so strong that it was difficult to remove the tape without causing damage. “Removing the tape could potentially create more of an inflammatory response in tissue, and prolong healing,” said Hyunwoo Yuk, another researcher involved in the study. “It’s a real practical problem.”

To address this, the researchers added a disulfide linker molecule that can be easily severed when exposed to a reducing agent, meaning that the covalent bonds between the adhesive and surface proteins in the tissue can be broken. The resulting tape can be sprayed with a reducing solution and it can then be readily peeled from a tissue surface, regardless of how long it has been in place. Most importantly, the removal is painless and does not cause tissue damage.

“This is like a painless Band-Aid for internal organs,” said Zhao. “You put the adhesive on, and if for any reason you want to take it off, you can do so on-demand, without pain.” Once sprayed, the tape needs to soak in the solution for about five minutes before it can be removed.

“That’s about the time it takes for the solution to diffuse through the tape to the surface where the tape meets the tissue,” said Xiaoyu Chen, a third researcher involved in the study. “At that point, the solution converts this extremely sticky adhesive to just a layer of slippery gel that you can easily peel off.”

Flashback: Bioinspired Double-Sided Surgical Tape Rapidly Seals Tissues Together

Via: MIT

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CIVILITY Mask Lets People See Each Others’ Faces During Pandemic

Since it seems that the virus that causes COVID-19 is going to be with us for a while, face masks will be around as well. As everyone who hasn’t worked in the OR before just noticed, not seeing the entirety of people’s faces influences how we interact with each other. Smiling, for example, completely loses the effect that it is meant to produce in others. And while this is a nuisance and discomfort for most people, those that are deaf or hard of hearing can’t see lip movement and therefore lose important information they use to communicate with others.

We’ve seen clear face masks created earlier in the pandemic, but these were crudely modified surgical masks. A better, albeit a more expensive, solution called CIVILITY has come from a team of French designers.

The CIVILITY mask keeps the important lower face features, including the nose and mouth, visible to others. The filtration components stay to the sides of the mouth, not hiding the face as is common with most masks.

This “smile-through” design, as the developers call it, allows people to communicate more normally. The strap design lets a wide swath of people fit the mask to their faces and maintain a tight fit that doesn’t let unfiltered air through.

Filters within the mask are FFP2 certified in the European Union (minimum 94% filtration of passing particles and maximum of 8% air leakage) and they can be removed and replaced with fresh ones. Each set of filters is designed to last about twelve hours, after which they should be replaced. The rest of the mask is reusable and can be cleaned safely using 70% alcohol solutions.

CIVILITY masks are now in pre-order for 35 euros (~$40) and they’ll come with 30 filters, enough to last for a month of regular usage, and a dustbag.

Here’s a short promo video presenting the CIVILITY mask:

Indiegogo campaign: CIVILITY – Next Gen Transparent Mask

Flashback: Clear Face Masks for The Deaf and Hard of Hearing

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Patch for Melanoma Treatment to Make Chemo Easier, Painless, More Effective

Scientists at Purdue University are reporting a skin patch that can deliver chemotherapy into melanoma tumors in an effective, convenient, and painless way. This may be an important development, as currently chemotherapy delivery options are limited and result in systemic exposure in the whole body and/or poor effectiveness.

Previous attempts at chemotherapy delivery via a patch required the use of large needles, which themselves dissolved way too fast once inside the skin to maintain continuous drug delivery. “We developed a novel wearable patch with fully miniaturized needles, enabling unobtrusive drug delivery through the skin for the management of skin cancers,” said Chi Hwan Lee, an assistant professor of biomedical engineering and mechanical engineering at Purdue in a press release. “Uniquely, this patch is fully dissolvable by body fluids in a programmable manner such that the patch substrate is dissolved within one minute after the introduction of needles into the skin, followed by gradual dissolution of the silicon needles inside the tissues within several months.”

The silicon needles on the new patch are so small that they could be called nanoneedles, and yet they have engineered angular tips, to help them penetrate into the skin, and tiny holes within which chemo agents can be loaded. The nanoneedles are attached to a water soluble film, which dissolves within a minute after application of the patch and all that’s left are the nanoneedles within the skin. Since the silicon nanoneedles take time to break up within the body, they have the time to deliver their therapeutic payload before dissolving.

So far, this is all a matter of laboratory work and a good deal of translational medical research will be required before such technology finds its space in the treatment of melanoma.

Study in ACS Nano: Bioresorbable, Miniaturized Porous Silicon Needles on a Flexible Water-Soluble Backing for Unobtrusive, Sustained Delivery of Chemotherapy

Flashback: Microneedle Patch Releases Immunotherapy Directly Into Melanoma Tumors

Via: Purdue

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Abbott’s Freestyle Libre 2 Advanced Wearable Glucometer FDA Cleared

After a long wait, the FDA has finally cleared Abbott’s FreeStyle Libre 2 continuous glucose monitor in the U.S. for any patients with diabetes over four years of age. The system provides low and high glucose level alarms, which let patients know in real-time if they’re falling outside of their normal range and it doesn’t require any fingersticks to calibrate it. Such technology can allow for significant improvements in patient comfort while offering exciting new capabilities for improved glucose management.

The FreeStyle Libre 2 can take blood glucose readings as often as every minute and a single disposable sensor patch can work for two weeks straight. To download measurements and do spot testing, an accompanying smartphone-like reader is simply placed near the sensor for a second to make the automatic transfer happen. If the sensor detects numbers outside of a set range, it can signal the reader to activate an alarm so that the patient or caretaker can take appropriate action to get the glucose back within range.

Patients can apply the patch all on their own and effectively forget about fingersticks, as according to Abbott, the FreeStyle Libre 2 “has a combined mean absolute relative difference (MARD), a measurement of performance for CGMs, of 9.3% (9.2% for adults and 9.7% for pediatrics), making it the only iCGM sensor sustaining a high level of accuracy over 14 days.”

“Innovations like FreeStyle Libre 2 will change the way people manage their diabetes, especially among children,” said Larry Kurt Midyett, M.D., pediatric endocrinologist, Midwest Women’s and Children’s Specialty Group, in an Abbott press release. “Using this technology can improve time in optimal glucose range and lower HbA1c because we can get a full picture of what a child’s glucose levels are doing without having to disrupt their play or sleep with painful fingersticks. The alarms are a bonus because they provide parents a level of reassurance.”

Here’s a promo video for the FreeStyle Libre 2:

Product page:FreeStyle Libre 2

Flashbacks: FreeStyle Libre 14 day System: Interview with Chris Thomas, Director of Biosensing Technology, Abbott; Abbott’s New FreeStyle Libre 2 Continuous Glucometer with Level Alarms Cleared in EU; Abbott’s FreeStyle Libre 14 Day Flash Glucose Monitor Approved in U.S.

Via: Abbott
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Medtronic Micra AV Transcatheter Heart Pacer Cleared in EU

Medtronic won the European Union CE Mark for its Micra AV pacemaker that’s delivered into the heart, where it resides without requiring any leads, using a minimally invasive transcatheter procedure.

The device is indicated for patients suffering from AV block, a condition that prevents proper electrical signal transfer between the atria and the ventricle. Micra AV addresses this condition by continuously monitoring the physical movement of the heart, using a built-in accelerometer, and adjusting how it paces the ventricle at every heartbeat.

“This new device not only stimulates but is also able to recognize the electrical activity of the whole heart. Our ultimate goal is to bring the latest cardiovascular innovation to patients in our area. Now we can extend this wireless technology to other patients who require dual-chamber stimulation and in whom traditional stimulation cannot be performed or is conditioned by previous infections, occlusions of the vessels of the upper extremities, etc.,” said Dr. José Ramón González Juanatey, director of the Cardiology and Intensive Cardiac Care Department at University Hospital, Santiago de Compostela, Spain, in a Medtronic press release.

Some relevant clinical trial data, according to the company:

The Micra AV approval is based on data from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study, which evaluated the safety and effectiveness of accelerometer-based atrial sensing algorithms. The study evaluated the ability of the Micra’s internal sensor to monitor and detect atrial contractions and enable coordinated pacing between the atrium and ventricle, thereby providing AV synchrony. Results from the study, presented at the American Heart Association 2019 Scientific Sessions and published simultaneously in JACC: Clinical Electrophysiology, showed the primary efficacy objective was met, with a significantly greater percentage of complete heart block patients with normal sinus rhythm having >70% AV synchrony during algorithm-mediated AV synchronous pacing (38 of 40 patients, 95%) than VVI pacing (0 patients, P<0.001 for proportion of patients with >70% synchrony). The study’s primary safety objective was also met, with no pauses or episodes of pacing-induced tachycardia reported during algorithm mediated AV synchronous pacing.

Product page:Micra AV

Flashbacks: Medtronic’s Tiny New Micra AV Pacemaker for AV Block FDA Approved; World’s Smallest Endocardial Pacemaker Getting Implanted in Initial Set of Patients; Medtronic’s Tiny Micra Pacemaker Going on a Space Flight; Medtronic’s Micra Pacemaker Survives Flight to Space; Medtronic’s Tiny Micra Leadless Pacemaker Approved in U.S.; Medtronic Introduces Micra, World’s Smallest Pacemaker; Medtronic Micra, World’s Smallest Pacemaker That Lives Inside Heart, Cleared in Europe

Via: Medtronic
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Neopenda NeoGuard Wearable Vital Signs Monitor for COVID-19: Interview with Sona Shah and Assumpta Nantume

Neopenda, a medical device startup based in Chicago that has been featured on Medgadget previously, has recently adapted its wearable vital signs monitor, originally developed for newborns, to be used with pediatric and adult patients in response to the COVID-19 pandemic.

To date, the neoGuard has been utilized as a monitoring solution for newborn infants in hospitals in Uganda. The wearable wirelessly streams vital signs, such as respiration rate, to a phone or tablet computer, allowing healthcare staff to monitor newborns on the move or remotely.

The technology has been useful in helping to reduce infant mortality in low-resource regions, where a lack of staff and clinical resources can make it difficult to monitor newborns for potentially life-threatening complications.

Now, Neopenda is modifying the Neoguard device so that it can measure vital signs in adults and children, with potential to help with the response to the COVID-19 pandemic. The company predicts that the device will help COVID-19 patients, as it could aid medical staff to respond more quickly to medical emergencies and may even help in identifying suspected cases who are being monitored.

Currently, Neopenda is running a crowdfunding campaign to help raise more money to expand the neoGuard solution to communities in need.

Medgadget had the opportunity to talk to Sona Shah, Neopenda CEO and Co-Founder, and Assumpta Nantume, Neopenda Research Director, Uganda, about the technology and recent developments in light of the pandemic.

Conn Hastings, Medgadget: Please give us an overview of the Neopenda vital signs monitor and how it works.

Sona Shah, Neopenda: neoGuard is a continuous vital signs monitor that measures pulse rate, respiration rate, oxygen saturation, and temperature through a simple headband. The vitals from multiple patients are wirelessly transmitted over bluetooth low energy to a centralized dashboard on a tablet. Our system helps overburdened healthcare workers better manage their patients, and improves speed of action for patients in distress. With just one tablet, nurses and clinicians can simultaneously observe up to 20 patients at a time and receive real-time audio and visual alerts if any of their vital signs exceed preset upper or lower limits. By detecting early warning scores for patients in distress, the neoGuard technology will help trigger more timely and effective clinical interventions and subsequently lower patient morbidity and mortality.

Medgadget: What are the advantages of the technology? How and where has it been used to date?

Assumpta Nantume, Neopenda: neoGuard was designed specifically for resource constrained environments, and as such is a more cost-effective, durable, and easy-to-use system than alternative vital signs monitors. The product has been developed with feedback from more than 400 health workers to ensure that it is appropriate for dynamic clinical settings and users. Neopenda has received a lot of interest and support from government, non-profit and private partners who share our vision for improved quality of care for critically ill patients.

To date, we have conducted several clinical trials both in Uganda and in the US to assess the feasibility, safety and accuracy of the technology. In May 2020, we launched use of neoGuard for remote monitoring of COVID-19 patients in Hawaii through our partnership with Queens Hospital. Between June–July 2020, we will be launching use of neoGuard in COVID-19 treatment facilities in Uganda and neonatal care units in Kenya.

Medgadget: How has the COVID-19 pandemic changed your plans for the monitor?

Sona Shah: We had intended to go-to-market with our neonatal vital signs monitor in mid-2020, starting in Uganda. As we witnessed the entire world becoming constrained in resources during the COVID pandemic, we quickly adapted our solution for use in adult and pediatric patients, and expanded the number of use cases and geographic reach for our product. Instead of cutting back on resources to extend the runway, we have doubled down to get neoGuard to market quicker and help during this pandemic.

While the pivot from our initial strategy has had its challenges, several of our implementing partners have supported our efforts and continued to work with us to equip COVID-19 treatment facilities for an effective response.

Medgadget: Please give us an overview of how the monitor could assist medical staff during the pandemic.

Sona Shah: In light of COVID-19, there has been a growing demand for vital sign monitoring equipment globally. neoGuard is unique in its ability to measure four vital signs as opposed to just one or two vital signs like most equipment.

Vital signs monitoring is crucial to help identify suspected cases for further testing, triage COVID-positive patients, and guide therapy. Since neoGuard has been designed for low-resource environments, we can readily adapt our solution to additional use cases, including isolation facilities, pop-up clinics and remote patient monitoring by community health workers and public health officials. We are currently piloting our remote patient monitoring use case with a hospital in Hawaii, and have engaged Ministries of Health and NGOs to deploy neoGuard as part of their COVID response.

The neoGuard system is also equipped with data capture tools to help synthesize both individual- and facility-level reports that are useful for predictive analytics, as well as planning and budgeting purposes. A technology like this is particularly valuable when handling a new disease like COVID-19 where the capacity to quickly acquire and study clinical insights as they are generated is incredibly important to curbing infections and deaths.

Medgadget: Has the pandemic created any challenges in scaling up production of the adult vital signs monitor?

Assumpta Nantume: Our contract manufacturer (CM) is based in Malaysia, which experienced a shutdown as a result of the pandemic. Our CM was able to receive a permit for limited operations during the shutdown, which allowed us to complete a pilot build. These units are currently being piloted at various facilities to demonstrate the applicability of neoGuard in the COVID response as we ramp up to mass production in the coming months. In parallel, we established a backup supply chain to quickly ramp-up production as needed to help fill the demand we are seeing for our product.

Medgadget: How have the monitors been used during the pandemic to date, and when do you envisage that you will be able to distribute more?

Assumpta Nantume: The monitors are currently being used in pilots to demonstrate the relevance of neoGuard during the COVID-19 pandemic both for remote patient monitoring and in resource-constrained facilities domestically and in emerging markets. We continue to engage new partners and facilities as we scale our solution and go through the appropriate regulatory pathways. We expect to have the ability to distribute at scale in Q3 2020.

Link: Neopenda homepage…

Flashback: Wearable Vital Signs Monitor for Newborns: Interview with Neopenda Co-founders Sona Shah and Teresa Cauvel
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