RPFT study - Registered Pulmonary Function Technologist Updated: 2023

In the ever-evolving landscape of healthcare, technology plays a pivotal role in shaping the future. The year 2024 promises to be a transformative one for the medical field, with groundbreaking innovations and emerging trends poised to revolutionize patient care, diagnostics, and healthcare systems. From artificial intelligence and telemedicine to wearable devices and genomics, these developments are set to usher in a new era of healthcare. In this article, we will explore the healthcare technology trends of 2024 and their potential impact on the medical industry.

Introduction

Artificial Intelligence (AI) in Healthcare

Artificial intelligence is becoming increasingly integral to healthcare, and 2024 is set to see a significant surge in its applications. AI-driven algorithms can analyze vast amounts of patient data to provide personalized treatment recommendations, improving diagnostic accuracy and treatment outcomes. From predicting disease progression to optimizing treatment plans, AI is transforming the way healthcare professionals make decisions. Machine learning algorithms are enabling early detection of diseases, such as cancer, by identifying subtle patterns and anomalies in medical imaging data. This not only enhances patient care but also reduces the burden on healthcare resources.

Telemedicine and Remote Patient Monitoring

Telemedicine has experienced unprecedented growth in recent years, and it’s set to become even more prevalent in 2024. With the ongoing demand for remote healthcare services, telemedicine is revolutionizing the way patients access medical care. Telehealth platforms allow patients to consult with healthcare professionals via video calls, making healthcare accessible and convenient, particularly for those in remote areas. Remote patient monitoring devices, which include wearables, help doctors track patients’ vital signs and health data from a distance. This trend is crucial in providing continuous care and early intervention for chronic conditions.

Wearable Health Devices

Wearable health devices have gained popularity over the years, and the trend is poised to escalate in 2024. These devices, such as smartwatches and fitness trackers, provide individuals with real-time health data, including heart rate, sleep patterns, and physical activity. They encourage people to take an active role in managing their health. Moreover, wearable devices can transmit data to healthcare providers, enabling proactive healthcare interventions and reducing hospital admissions. As these devices become more sophisticated, they will play a crucial role in health monitoring and preventive care.

Genomics and Personalized Medicine

Genomic medicine is on the brink of a major breakthrough in 2024. The study of an individual’s DNA can provide insights into their susceptibility to certain diseases and how they may respond to specific treatments. With advancements in genomics, healthcare professionals can offer personalized treatment plans tailored to a patient’s genetic makeup. This not only enhances the effectiveness of treatments but also reduces adverse effects. The integration of genomics into routine clinical practice is set to revolutionize the healthcare landscape, particularly in the field of oncology.

Blockchain for Health Records

Data security and patient privacy are paramount in healthcare, and blockchain technology is poised to address these concerns. Blockchain provides a secure and transparent way to store and share health records. In 2024, we can expect to see an increasing adoption of blockchain for managing electronic health records. Patients can have more control over their data, granting access to healthcare providers as needed while ensuring their information remains confidential and tamper-proof.

Virtual Reality (VR) in Medical Training

Virtual reality is not just for gaming; it’s making significant inroads into medical training and education. Medical students and professionals can now immerse themselves in realistic, 3D medical simulations. These simulations allow for hands-on practice in a risk-free environment, improving skills and knowledge retention. In 2024, we can anticipate a more extensive use of VR in medical training, leading to better-prepared healthcare providers.

3D Printing in Healthcare

The use of 3D printing in healthcare is expanding rapidly, and 2024 will witness its continued growth. Researchers and healthcare professionals are using 3D printing technology to produce custom implants, prosthetics, and even organs. This technology holds immense potential for enhancing patient outcomes and lowering healthcare costs. From manufacturing dental implants to creating orthopedic devices, 3D printing is transforming the production and customization of healthcare products.

Health Informatics and Big Data Analytics

The accumulation of healthcare data is growing exponentially, and harnessing this data through health informatics and big data analytics is pivotal in making informed decisions. In 2024, we can expect to see further advancements in data analysis tools that help healthcare providers identify trends, optimize resource allocation, and enhance patient care. Big data analytics can uncover insights into disease outbreaks, treatment efficacy, and healthcare system performance, ultimately improving healthcare delivery.

Robotics in Surgery

In 2024, surgical robots will play an expanding role in operating rooms. They will offer precise, minimally invasive surgery, thereby reducing patient trauma and recovery times. Surgeons will control robotic arms remotely, ensuring high precision and dexterity in delicate procedures. As the technology advances, we can anticipate the assistance of surgical robots in performing even more complex surgeries.

Augmented Reality (AR) for Medical Visualization

Augmented reality is enhancing medical visualization and surgical planning. Surgeons can overlay digital information onto the patient’s body during surgery, providing real-time guidance and improving accuracy. In 2024, we expect the growth of AR technology integration to make complex surgeries safer and more efficient.

Conclusion

In conclusion, the year 2024 promises to be a remarkable year for healthcare technology, with numerous trends and innovations poised to reshape the medical field.  By harnessing the power of these technologies, the healthcare industry can provide more personalized, efficient, and accessible care to patients around the world. The future of healthcare is bright, and the ongoing fusion of technology and medicine is revolutionizing the way we approach healthcare delivery. As these trends continue to evolve, we can look forward to a healthier and more technologically advanced world of medicine.

An international team of scientists has uncovered the vital role of microglia, the immune cells in the brain that acts as its dedicated defense team, in early human brain development. By incorporating microglia into lab-grown brain organoids, scientists were able mimic the complex environment within the developing human brain to understand how microglia influence brain cell growth and development.

This research represents a significant leap forward in the development of human brain organoids and has the potential to significantly impact our understanding of brain development and disorders.

The study, "iPS-cell-derived microglia promote brain organoid maturation via cholesterol transfer" was published in Nature on 1 November 2023.

To investigate microglia's crucial role in early human brain development, scientists from A*STAR's Singapore Immunology Network (SIgN) led by Professor Florent Ginhoux, utilized cutting-edge technology to create brain-like structures called organoids, also known as "mini-brains" in the laboratory. These brain organoids closely resemble the development of the human brain. However, previous models were lacking in microglia, a key component of early brain development.

To bridge this gap, A*STAR researchers designed a unique protocol to introduce microglia-like cells generated from the same human stem cells used to create the brain organoids. These introduced cells not only behaved like real microglia but also influenced the development of other brain cells within the organoids.

A*STAR's Institute of Molecular and Cell Biology (IMCB)'s Dr. Radoslaw Sobota and his team at the SingMass National Laboratory for Mass Spectrometry applied cutting edge quantitative proteomics approach to uncover changes in protein. Their analysis provided crucial insights into the protein composition of the organoids, further confirming the study's findings.

What sets this study apart is the discovery of a unique pathway through which microglia interact with other brain cells. The study found that microglia play a crucial role in regulating cholesterol levels in the brain. The microglia-like cells were found to contain lipid droplets containing cholesterol, which were released and taken up by other developing brain cells in the organoids. This cholesterol exchange was shown to significantly enhance the growth and development of these brain cells, especially their progenitors.

Cholesterol, makes up about 25% of the body's total cholesterol content, is abundantly present in the brain and is essential for the structure and function of neurons. Abnormal cholesterol metabolism has been linked to various neurological disorders, including Alzheimer's and Parkinson's Disease.

To investigate the roles of lipids in brain development and disease, researchers from the Department of Biochemistry at the Yong Loo Lin School of Medicine (NUS Medicine), led by Professor Markus Wenk, took on the crucial task of data acquisition, particularly in the field of lipidomics to draw valuable insights into the lipid composition and dynamics within the brain organoids containing microglia.

Using this information, another team from the Department of Microbiology and Immunology at NUS Medicine and led by Associate Professor Veronique Angeli, found that cholesterol affects the growth and development of young brain cells in human brain models. Microglia use a specific protein to release cholesterol, and when this process is blocked, it causes the organoid cells to grow more, leading to larger brain models.

"It has always been known that the microglia is key to brain development, however their precise role remains poorly understood. This finding from our team at the Department of Microbiology and Immunology is particularly impactful because we finally understand how cholesterol is transported. Our next focus will be finding out how we can regulate cholesterol release to optimize brain development and slow down, or prevent, the onset of neurological conditions," said Assoc Prof Veronique, who is also Director of the Immunology Translational Research Program at NUS Medicine.

Moreover, Dr. Olivier Cexus from the University of Surrey and formerly at A*STAR, progressively deciphered the complex molecular interactions within the brain organoids using proteomic and lipidomic analysis. This provided valuable insights into the metabolic cross-talks involved in brain development and potential implications for diseases.

Together, these collective efforts were instrumental in deepening our understanding of the roles of microglia and the molecular components within brain organoids and its implications for human health.

Prof Florent Ginhoux, Senior Principal Investigator at A*STAR's SIgN and Senior author of the study said, "Understanding the complex roles of microglia in brain development and function is an active area of research. Our findings not only advance our understanding of human brain development but also have the potential to impact our knowledge of brain disorders. This opens up new possibilities for future research into neurodevelopmental conditions and potential therapies."

Co-author of the study, Professor Jerry Chan, Senior Consultant, Department of Reproductive Medicine, KK Women's and Children's Hospital, and Senior National Medical Research Council Clinician Scientist, added, "There is currently a lack of tools to study how microglia interacts with the developing brain. This has hampered the understanding of microglia-associated diseases that play an important role during the early development of conditions such as autism, schizophrenia, and neurodegenerative diseases such as Alzheimer's and Parkinson's disease.

"The development of these novel microglia-associated brain organoids with same-donor pluripotent stem cells gives us an opportunity to study the complex interactions between microglia and neurons during early brain development. Consequentially, this may enable us to study the role of microglia in the setting of diseases and suggest ways to develop new therapies in time."

Jiang Li, Ph.D., is the Founder and CEO of Vivalink, Inc.

Wearable technology has become a valuable tool for managing patient conditions and gathering real-time data, whether in routine healthcare monitoring or decentralized clinical trials. However, ensuring patient adherence to wearables remains a primary challenge in remote patient monitoring (RPM).

Patient adherence to the technologies associated with remote data collection is crucial for the success of RPM and clinical trials. Reliable data collection hinges on patients following the directions for using RPM devices to fully maximize their potential. And the older the age group, the bigger the challenge with technology.

Historically, patients have grappled with adherence, with approximately 50% of prescribed medications for chronic diseases not being taken as directed. The challenge extends to medical devices, and ensuring patient adherence to wearables is equally important for successful healthcare.

Wearable device manufacturers and providers can implement measures to address patient adherence challenges. By introducing innovative solutions and prioritizing user-centric design, they play a crucial role in improving patient adherence, ultimately contributing to enhanced healthcare outcomes and advancements.

Factors Affecting Patient Adherence

To effectively tackle patient adherence obstacles, healthcare providers, researchers and developers must have a comprehensive grasp of the underlying factors. These key challenges include:

• Technology Complexity: The complexity of some wearable devices can be a significant barrier to patient adherence. Patients, especially those unfamiliar with mobile devices and wearables, may find the technology overwhelming, deterring them from effectively using them.

• Lifestyle Compatibility: A patient's lifestyle plays a crucial role in adhering to wearables. For instance, if a device is bulky and must be removed before activities like showering, patients may find it inconvenient and opt to skip wearing it during such times.

• Physical Limitations: Physical limitations, often prevalent in older or chronically ill patients, can hinder their ability to use wearables effectively.

• Forgetfulness And Lack Of Motivation: Patients, no matter how well-intentioned, can sometimes forget to wear their devices or neglect them for various reasons. It's not uncommon for a patient to overlook wearing a device, especially if they don't perceive immediate benefits or if using the device disrupts their routine.

Age And Disease Considerations

Age significantly influences wearable usage and adherence, resulting in distinct challenges and preferences among age groups. Most users of medical-grade wearables are older individuals managing chronic conditions like cardiovascular issues, diabetes and respiratory ailments or following an acute procedure such as post-surgery.

Older patients may face initial hurdles in adhering to wearables, due in part to limited technology exposure and apprehension about the device. Younger, more tech-savvy patients are more likely to embrace wearables for health tracking and management.

However, individual proficiency levels can vary greatly. To effectively cater to the diverse needs of patients across different age groups, it's crucial to avoid making sweeping assumptions and offer customized support and training across all patient demographics.

Patients' disease states also influence wearable adherence. For example, chronic conditions like diabetes and hypertension require continuous monitoring and data sharing. Patients with such conditions are more likely to embrace wearables that facilitate daily health tracking and data sharing with providers.

Acute health issues from injuries or sudden illnesses may require temporary wearable devices for diagnostic or follow-up purposes, with varying degrees of adherence. Recognizing the interplay between age and disease states enables providers and researchers to customize their approach, enhancing the overall healthcare experience for patients.

Clinical Trials Vs. Healthcare

Patient adherence varies between clinical trials and healthcare settings. In clinical trials, researchers typically assess adherence after the trial concludes. Patients' awareness of their participation may motivate them to follow the study protocol. However, incomplete or inaccurate data can compromise trial outcomes and conclusions. To maintain data integrity, researchers should consider employing strategies such as compliance monitoring and robust data analysis.

In healthcare, continuous or real-time data is more widely used, but it's especially critical in acute situations in which active monitoring may be required over a continuous period. When patients experience their actions' impact on their health and are engaged in managing their well-being, they're more likely to adhere to using wearables and follow treatment plans.

Providers, researchers and developers must understand the differences in patient adherence between clinical trials and healthcare settings. They can develop tailored strategies and solutions for optimizing adherence, enhancing patient outcomes and improving trial data quality.

Addressing Adherence Challenges

Overcoming patient adherence challenges requires multifaceted solutions. Wearable manufacturers and developers must design easy-to-use interfaces. For older or less tech-savvy users, larger font sizes and clear instructions are essential accessibility features. Simplifying the setup process by bundling cellular connections can minimize technical challenges, ensuring users can activate their devices with ease.

Another crucial aspect of improving adherence is ensuring wearable technology aligns with patients' lifestyles. Manufacturers typically offer a range of devices, each optimized to perform effectively in its intended scenario. Selecting the right wearable and considering factors like water resistance, durability and comfort is crucial. Manufacturers should customize their technology to specific customer needs, tailoring it to each study or application's specific requirements.

To address physical limitations, especially in older or ill patients, healthcare professionals can apply wearables in the clinic, ensuring proper and comfortable device placement for patients. In cases in which physical limitations or remote locations pose challenges, clinicians could consider home visits. Patients with physical limitations can benefit from customizable devices, such as those equipped with adhesive patches and adjustable straps.

Integrated reminders, whether within wearable apps or as push notifications, encourage consistent device usage. In one study, atrial fibrillation patients who received smartwatch notifications alongside standard care were more likely to adhere to medication regimens. Compliance dashboards allow clinicians to track which devices have been active on specific days and assess the overall connectivity percentage, enabling prompt intervention when detecting non-adherence.

Patient Adherence And The Future Of Medical Wearables

Patient adherence is critical to unlocking medical wearables' full potential. Without high adherence levels, devices can't maximize remote patient monitoring and clinical trials. To further advance the field, ongoing research and development is imperative. Manufacturers must continue to innovate and customize solutions to overcome adherence challenges.

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A new study has revealed that the body’s hormone stress response is why some people develop post-traumatic stress disorder following trauma exposure, and others don’t. The finding could lead to more targeted treatments for the condition.

Some people develop post-traumatic stress disorder (PTSD) following exposure to a traumatic event or events, causing notable impairments such as intrusive thoughts, avoiding behaviors, sleep disturbance and hypervigilance.

Crucial to identifying the condition early, and treating it effectively, is understanding why some people, and not others, develop PTSD. Now, a new study by researchers at the Swiss Federal Institute of Technology Lausanne (EPFL) has shown why a subset of people are more vulnerable, and it has to do with the body’s stress hormone response.

“There are considerable differences in the levels of glucocorticoids that individuals release to the bloodstream when stressed,” said Carmen Sandi, one of the study’s corresponding authors. “Low glucocorticoid levels are frequently observed in PTSD patients following trauma exposure and were initially suspected to be a consequence of trauma exposure.”

Glucocorticoids are steroid hormones produced by the adrenal glands, which sit atop each kidney. The essential glucocorticoid the body produces is cortisol, the primary stress hormone that works with certain parts of the brain to control mood, motivation, and fear. Following the fight-or-flight response, if the brain continues to perceive something as dangerous, it triggers a pathway that results in the release of cortisol.

While low glucocorticoid levels and a smaller hippocampus, the area of the brain involved in long-term memory formation and memory retrieval, were originally thought to result from trauma, they’re currently viewed as potential risk factors for PTSD. However, establishing their causal role in the condition has proven difficult.

“The possibility that this could be a trait constituting a preexisting PTSD risk factor has been an outstanding open question for many years, but tackling it has been challenging due to the difficulties of both collecting biological measures before trauma exposure and having access to relevant animal models in which the causal role of these traits can be investigated," said Sandi.

To examine how a reduced hormonal response to stress might be linked to PTSD symptoms, the researchers used rats that had been genetically modified to mimic humans with a blunted response to cortisol. They measured the volume of different brain regions, trained rats to associate a cue with fear, recorded their sleep patterns, and measured their brain activity.

The researchers discovered that decreased responsiveness to glucocorticoids led to several pivotal PTSD vulnerability traits, including impaired fear extinction (in male rats), reduced hippocampal volume, and rapid-eye-movement sleep (REMS) disturbances. Fear extinction is a process by which a conditioned fear response diminishes over time; problems with fear extinction mark PTSD. REMS is crucial for memory consolidation, and people with PTSD often experience REMS disturbances. From this, the researchers concluded these traits are biologically interconnected and not independent risk factors.

Next, the rats were given the equivalent of cognitive behavioral therapy to reduce their learned fears and then administered corticosterone, the murine version of cortisol. The researchers noted that both excessive fear and REM sleep disturbances abated. In addition, increased levels of the fight-or-flight neurotransmitter norepinephrine in the brain returned to normal.

“Our study provides causal evidence of a direct implication of low glucocorticoid responsiveness in the development of PTSD symptomatology following exposure to traumatic experiences, i.e., impaired fear extinction,” Sandi said. “In addition, it shows that low glucocorticoids are causally implicated in the determination of other risk factors and symptoms that were until now only independently related to PTSD.”

The study’s findings open the door to potential treatment for people with PTSD.

“Our research illuminates previously elusive aspects of PTSD, revealing that blunted corticosteroid responsiveness not only predicts but may also contribute causally to core PTSD symptoms,” the researchers said. “This suggests potential benefits of glucocorticoid treatments for patients with diminished glucocorticoid responsiveness.”

The study was published in the journal Biological Psychiatry.

Source: EPFL

Air filtration systems do not reduce the risk of picking up viral infections, according to new research from the University of East Anglia.

A new study published today reveals that technologies designed to make social interactions safer in indoor spaces are not effective in the real world.

The team studied technologies including air filtration, germicidal lights and ionizers.

They looked at all the available evidence but found little to support hopes that these technologies can make air safe from respiratory or gastrointestinal infections.

Air cleaners are designed to filter pollutants or contaminants out of the air that passes through them.

When the Covid pandemic hit, many large companies and governments - including the NHS, the British military, and New York City and regional German governments - investigated installing this type of technology in a bid to reduce airborne virus particles in buildings and small spaces.

But air treatment technologies can be expensive. So it's reasonable to weigh up the benefits against costs, and to understand the current capabilities of such technologies."

Prof Paul Hunter, from UEA's Norwich Medical School

The research team studied evidence about whether air cleaning technologies make people safe from catching airborne respiratory or gastrointestinal infections.

They analyzed evidence about microbial infections or symptoms in people exposed or not to air treatment technologies in 32 studies, all conducted in real world settings like schools or care homes. So far none of the studies of air treatment started during the Covid era have been published.

Lead researcher Dr Julii Brainard, also from UEA's Norwich Medical School, said: "The kinds of technologies that we considered included filtration, germicidal lights, ionisers and any other way of safely removing viruses or deactivating them in breathable air.

"In short, we found no strong evidence that air treatment technologies are likely to protect people in real world settings.

"There is a lot of existing evidence that environmental and surface contamination can be reduced by several air treatment strategies, especially germicidal lights and high efficiency particulate air filtration (HEPA). But the combined evidence was that these technologies don't stop or reduce illness.

"There was some weak evidence that the air treatment methods reduced likelihood of infection, but this evidence seems biased and imbalanced.

"We strongly suspect that there were some relevant studies with very minor or no effect but these were never published.

"Our findings are disappointing - but it is vital that public health decision makers have a full picture.

"Hopefully those studies that have been done during Covid will be published soon and we can make a more informed judgment about what the value of air treatment may have been during the pandemic."

This research was led by the University of East Anglia with collaborators at University College London, the University of Essex, the Norfolk and Norwich University Hospital Trust, and the University of Surrey.

It was funded by the National Institute for Health and Care Research Health Protection Unit in Emergency Preparedness and Response, led by Kings College London and UEA in collaboration with the UK Health Security Agency.

'Effectiveness of filtering or decontaminating air to reduce or prevent respiratory infections: A systematic review' is published in Preventive Medicine.

SALT LAKE CITY, Utah (Ivanhoe Newswire) – In a surprising healthcare revelation, some hospitals have found that life-saving solutions don’t always come from the latest technology or costly equipment. A simple shift in how doctors conduct their rounds is making a monumental difference in patient care and, more importantly, in saving lives.

Outside the hospital room of Allison’s eight-year-old daughter, a team of medical experts are working on a treatment plan.

“Within 24 hours, she went from a little rash showing up on her ankle to, in the ER, dangerous blood pressure drop, swollen face and hands,” she recalls.

But Allison knows when it comes to her daughter, she is the expert, and at Primary Children’s Hospital, she is treated like one.

“They weren’t just coming to me and telling everything they were going to do, we were making a plan together, like, ‘This is what we can offer, this is what we can do, what do you think? How will this work best for her?’ And it just has been, I didn’t know that hospitals could work like this and I love it,” Allison expresses.

University of Utah Health and Intermountain Primary Children’s Hospital doctor, Irene Kocolas, MD says, “We’re really able to engage our families and our parents. Who knows a child best than their family?”

The traditional way of patient care often left parents in the dark, their input overlooked or ignored by the medical team. But family-centered rounding is reshaping how medical teams communicate with families – planning with them instead of for them. Such a simple change is redefining patient care.

“When we’re all working together, the parent, the nurse and the physician team, not only do we feel like we have better communication, we decrease our errors,” Dr. Kocolas mentions.

Allison tells Ivanhoe, “I feel like I have a family that are all taking care of me. I feel like I can trust them and I can open my mouth about anything on my mind and they will listen and see what they can do about it.”

A recent study found a 38 percent decrease in preventable medical errors when family-centered rounding was implemented.

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The Recor Medical Paradise ultrasound RDN system uses a water-filled balloon catheter for 360-degree sonification to ablate overactive nerves in the walls of the renal arteries. [Illustration courtesy of Recor Medical]

Recor Medical held a companywide town hall for employees to celebrate winning premarket approval (PMA) for their Paradise Ultrasound RDN system. While they were celebrating, the team learned that the very first commercial procedure had just been completed.

“After a pretty long journey of many years — the rigorous clinical trials that we ran, and all the work that they’ve done —  they were actually seeing, finally, this wonderful result of a PMA,” Recor President and CEO Lara Barghout said. “We hit the ground running immediately. … It was such an incredible, emotional moment for the team to be talking together at a townhall and then getting the news about the patient.”

In an interview with Medical Design & Outsourcing, Barghout discussed the long road to approval, the technology that made it possible, and how Recor accomplished what medtech giants could not over the past decade.

“It’s incredible to have the first renal denervation therapy launched through a company with this passion and technology. … We also want to get it to as many patients as we can,” she said. “And it was great to see that we were able to do that so quickly after approval.”

Dueling RDN technologies

Recor won a race that Medtronic — now the largest medical device manufacturer in the world —  has been running since buying RDN developer Ardien in 2011. Boston Scientific was a contender with its Vessix RDN technology, but bowed out after a failed trial in 2018.

The stakes are huge. More than 1.2 billion people have hypertension worldwide, but most don’t have it under control, causing heart attacks, strokes, kidney damage and premature deaths. Medtronic estimates renal denervation could be a multibillion-dollar business.

“Getting a renal denervation therapy to market is one of the biggest wins that the world of devices has seen in a really long time,” Barghout said.

Medtronic and Recor designed their competing systems to ablate overactive nerves between the brain and the kidneys that help regulate blood pressure. RDN therapy uses minimally invasive catheters inside the renal arteries to apply energy and calm those nerves in the artery walls, lowering a patient’s blood pressure.

Recor seemed lined up for approval in August when medical and statistical experts on the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee determined the Paradise Ultrasound RDN system was safe and effective. One day later, the same experts voted that the risks of competing technology from Medtronic outweighed its benefits.

Recor’s first-of-its-kind ultrasound RDN system hit all of its primary endpoints in its clinical trials. While Medtronic’s clinical trials hit their safety targets both in 2022 and 2014, they missed their primary endpoints on efficacy.

Medtronic’s Symplicity Spyral RDN system uses a self-expanding radiofrequency catheter with four electrodes to apply that energy.

The Recor Medical Paradise ultrasound RDN system delivers 360-degree sonications to ablate overactive nerves inside the renal arteries, lowering a patient’s blood pressure. [Illustration courtesy of Recor Medical]

“The most important thing as the denervation procedure is being done is to be able to reach the nerves in the renal artery to make sure there’s been denervation and that the therapy is actually effective,” Barghout said. “Having a 360 sonication is one of the biggest differentiators besides the fact that it’s an ultrasound wave.”

Medtronic congratulated Recor for its FDA approval in a statement shared with MassDevice, calling it “a significant milestone in the field of RDN and for patients and physicians.”

“Medtronic welcomes innovation in the field of renal denervation as it provides further validation of the therapy as a complementary treatment option in reducing blood pressure for patients, in addition to medications and lifestyle changes,” the company said. “Medtronic remains confident in the therapy and continues to have productive discussions with FDA regarding our PMA submission. We look forward to hearing soon from FDA.”

Recor’s believers

Recor Medical CEO and President Lara Barghout [Photo courtesy of Recor Medical]

One of the things she’s learned about Recor’s employees in her first year at the helm is how passionate they are about the technology they’ve been developing for so long.

“They are big believers that it actually is effective. One of the things that continue to drive them is the confidence they have in the fact that this technology is actually going to yield phenomenal results for patients,” she said. “It’s simple because the theory behind the therapy — and if you look at how our product is designed — it’s extremely natural to know that this is going to be effective.”

That kept them pushing toward the finish line and lifted them over their biggest hurdle: designing the clinical trials to demonstrate the system’s value.

“Creativity, being able to be consistent, be rigorous, and be patient about recruiting the right patients and continuing to support the protocol that they all aligned on with our physician partners is what really continued to drive them,” Barghout said. “There were three randomized, sham-controlled studies that we did and the minute that the first study resulted in positive outcomes — our Solo trial — that’s when they knew they just had to finish it off.”

Each small milestone and continued confidence in the therapy gave them “the breath to continue on,” she said.

In 2018, venture capital firm Sofinnova Partners sold Recor to Otsuka Medical Devices, which provided financial stability to keep device development and clinical trials on track even through COVID-19 pandemic disruptions.

“The continuous breath that they had from the Otsuka side to continue to support the team was also a pretty significant portion of how the team continued to keep going,” Barghout said.

Trial design

Because Recor’s Paradise system hit its endpoints in all three trials, “the potential of not having an FDA approval was extremely low in our books,” Barghout said.

“Our goal was to continue to drive until we get to an FDA approval,” she said. “There was no backup plan, and if we were not able to meet that goal in those three clinical trials, we probably would have run more — but it was not necessary.”

She credited the Recor team with developing “solid” trial protocols and for their specific patient selection criteria. The involvement of medication was a challenge for Recor’s trials and hypertension device trials more broadly.

“Mainly what really is needed is for patients to adhere to the medication protocol, whether it’s an onmed or an offmed trial, and to adhere to the follow-up that’s needed after the procedure is done,” Barghout said.

And it can be a challenge to find patients willing to participate in a sham-controlled trial because they might not want to be part of the control arm that doesn’t get the treatment.

“The protocol was rigorous, and the patient selection was rigorous, and the team continued to drive according to the plan,” Barghout said.

What’s next

Recor is planning for growth to get more doctors on board and more patients treated. Some of the first procedures were conducted by cardiologists who participated in the clinical trials. Others had been waiting for FDA approval to use the system for the first time.

Barghout wouldn’t disclose exactly how many employees Recor has, but said it’s between 300 and 500. They’ll be joined by new colleagues not only on the commercial side, but also new hires in innovation and R&D, for the clinical team, and infrastructure.

“The first thing is we continue to drive for commercialization, but also we have a huge passion for innovation,” Barghout said. “We’re going to continue to innovate in the world of hypertension therapy, we’re going to continue to innovate in creating and developing data to prove that this therapy is an important part of the world of healthcare and that it can help patients live a healthier life.”

She also sees potential for more innovation in the sympathetic nervous system and treating other chronic diseases with denervation.

“I’m always inspired when I talk to physicians after they treat their patients to understand how the patient’s journey was and how would they be after the procedure,” Barghout said. “That, for me, is what Recor is all about. We are a mission-driven organization. We think about patients first, and we think about everything else after that. I’m really excited to see the team with all the hard work that they’ve done, that we are able to hit all the goals that are in front of us.”

MISSOULA, Mont. — A University of Montana student was awarded a renowned fellowship to study at the University of Oxford in the United Kingdom.

Kolter Stevenson is the first UM student in 30 years to receive the Rhodes Scholarship for study at the University of Oxford.

The two-year program only selects 32 American college students and the university is one of the most prestigious in the world.

The University of Montana released the following:

A University of Montana student who wove connections between the Russian language, business, renewable energy, data and entrepreneurship recently was awarded the oldest and most renowned fellowship in the world.

Kolter Stevenson, of Amsterdam, Montana, and an alumnus of Manhattan High School, is the first UM student in 30 years to receive the Rhodes Scholarship for study at the University of Oxford in the United Kingdom.

“It’s an honor to represent the State of Montana,” Stevenson said. “I share this award with my entire team who supported me in this journey. I’m still taking in the news.”

He is one of 32 American college students who were named 2024 Rhodes Scholars. Stevenson is the only student from Washington, Montana, Idaho, Oregon, and Alaska to be selected for two-year postbaccalaureate study at one of the world’s most prestigious institutions.

“Kolter embodies the talent and promise of Montana and the impact of a UM education at its best,” UM President Seth Bodnar said. “We’re here to ignite in students a desire to solve complex challenges and to provide a broad-base education and specific skills to ultimately make the world a better place. We are beyond proud to celebrate Kolter as UM’s existing Rhodes Scholar and as one of Montana’s – and our nation’s – greatest treasures. The entire state should join UM in celebrating this extraordinary achievement.”

Enrolled in four UM majors and carrying a 4.0 GPA in each one, Stevenson, a UM senior, was celebrated in letters of recommendation from UM faculty for his humble leadership, high intellect, varied interests, and insatiable curiosity related to renewable energy, globalization, languages, culture and data.

He also speaks four languages, including Russian, Norwegian, Spanish and English.

“It’s a gift and a blessing when you’re able to talk to someone in their own language,” Stevenson said. “The cultural learning is just much deeper, and when you can switch to their language, there’s tenfold the understanding.”

Stevenson said he found intellectual rigor and opportunity at UM in the majors of management information systems, finance and international business, with a certificate in big data analytics, each housed in UM’s College of Business.

Stevenson also studies Russian in UM’s College of Humanities and Sciences and is enrolled at UM as a Presidential Leadership Scholar in UM’s Davidson Honors College.

Of particular interest to Stevenson is UM’s cornerstone strength in World Languages and Cultures, where he found a family of sorts in UM’s Russian program. He was tutored and mentored by Ona Renner-Fahey, professor of Russian, and Clint Walker, associate professor of Russian.

“Without hyperbole, I can say that in many respects Kolter is the most impressive student I have ever had in over 25 years of teaching,” said Renner-Fahey. “"He is intelligent and driven but, more than that, he is also an unusually kind and humble person who possesses a seemingly endless amount of energy and genuine desire to make the world a better place.”

Stevenson found Russian by way of Norwegian, when he independently sought to dive deeper into his family’s roots by studying in Bergen, Norway, for his junior year of high school. He was the first student from Manhattan High School to ever participate in a foreign exchange. It was there he encountered a particularly gifted Russian language instructor.

“I remember my brain really hurt that fall, when I was memorizing and learning Russian but all through Norwegian,” he said. “But once I got it, it was like a math equation that finally fell into place.”

In 2022, Stevenson was awarded a Critical Language Scholarship with the U.S. Department of State to spend a summer Bishkek, Kyrgyzstan, to enhance his Russian and research energy production across Central Asia.

It was in Kyrgyzstan that Stevenson discovered a deep interest in renewable energy and sustainable technologies for Central Asian economies. He plans to continue studying the intersection of diplomacy, cultural sovereignty and energy in Russian-speaking regions while at Oxford.

After graduating from Manhattan High School, Stevenson was the only student in his class to enroll in UM, where he was selected as a Presidential Leadership Scholar. He said he felt a natural connection with UM’s Davidson Honors College faculty and staff, including Tim Nichols, dean of the DHC; Bethany Applegate, DHC director of Student Engagement; and Kylla Benes, director of UM’s Office of External Scholarships.

“He has a rare combination of academic, interpersonal and technical skills that will enable him to reach his goals,” Nichols said. “An investment in Mr. Stevenson is an investment in a driven, innovative, culturally competent, selfless leader who will help the U.S. collaborate with other nations.”

Nichols and Stevenson also praised the work of Kylla Benes, UM's director of external scholarships and fellowships, who guided Stevenson through the complex Rhodes application and interview process.

While immersed in Russian at UM, Stevenson wished to combine language expertise with other majors like management information systems and finance so that he could hone applicable skills in any field, such as data analysis, resource modeling and coding.

He was particularly inspired by classes taught by Jason Triche, associate professor management information systems, and leveraged Triche’s mentorship to develop a sentiment analysis using natural language processing on interviews with Russian and Ukrainian refugees in Montana, with hopes to discover their sentiments about using nonprofit humanitarian organizations.

“The outcomes of his independent study could help the city, state and area nonprofits create a sustainable and safe community for Ukrainian people settling in Montana,” Triche said.

Inspired by an old radiator in his dorm room in Knowles Hall (before the building’s recent renovations) – working with his friend and roommate – Stevenson parlayed skills in analytical technology to develop Smart Dorm, a technology that can analyze energy waste and increase energy efficiency and comfort for tenants.

The business’s technology is currently undergoing patent approval and has a been named a national finalist for the U.S. Department of Energy’s Grid Enhancing Technology category.

While earning four majors and enjoying evenings at Spanish and Russian-speaking events, Stevenson has also made time to enjoy life as a student at UM.

He has taught alpine ski lessons as a Professional Ski Instructor of America at the Yellowstone Club, in addition to volunteering as a firefighter and emergency medical technician with the East Missoula Rural Fire District and Frenchtown Rural Fire District.

“I am only sitting here as a Rhodes because of the incredible faculty, mentors and community families that I have,” Stevenson said. “I’m convinced there is not another university in the country where I could have had these opportunities and this level of support.”

Each year, thousands of Rhodes Scholarship applications are submitted by colleges and universities across the world. Applicants who demonstrate academic excellence, the ability to lead and care for vulnerable members of society are selected as finalists. They participate in a two-day interview process that determines the winners.

UM has produced 29 Rhodes scholars in its history. The last Rhodes scholars at UM were Charlotte Morrison in 1993 and Scott Bear Don’t Walk in 1992.

UM’s former Rhodes finalists were Beatrix Frissell in 2022; Arwen Baxter and Teigan Avery in 2021; alumnus Ryan Garnsey in 2020; alumna Mara Menahan in 2014 and alumnus Derek Crittenden in 2015. UM President Seth Bodnar and his wife, Dr. Chelsea Bodnar, are also former Rhodes Scholars.

Stevenson thanked UM faculty and staff for their support and encouragement including:

Clint Walker, associate professor of Russian, College of Humanities and Sciences.

Jason Triche, associate professor Management Information Systems, College of Business.

Kylla Benes, Davidson Honors College director UM’s Office of External Scholarships.

Michael Harrington, professor of Management Information Systems, College of Business.

Ona Renner-Fahey, professor of Russian, College of Humanities and Sciences.

Sara Truglio, program manager, Blackstone LaunchPad.

Tim Nichols, dean of the Davidson Honors College.

Tyler Munoz, chief, East Missoula Rural Fire District.

Katie White, Yellowstone Club.