Category: Medical Tools

From needles To MRI Machines, Medical ‘Device’ Exports Up 8.14{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}

Good news and bad news. Sort of.

The value of medical-instrument exports, one of the top U.S. exports this year, is growing at less than half the rate of overall U.S. exports.

That’s the bad news.

The category, which includes everything from needles and sutures to MRI and ultrasound machinery, are still increasing at a pace sufficient to lead to a record year, when annual totals are released in early February.

Now, the good news: Through September, according to the most recent U.S. Census Bureau data, exports in the category were up 8.14{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} to $26.46 billion. U.S. exports increased 21.04{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} and stand a chance of topping $2 trillion for the first time in 2022.

This post, focused on medical instruments, which ranked 10th when this series on U.S. exports began, is the 12th and final post in a series of columns about the nation’s exports. It currently ranks 12th, trailing gold, which entered the top 10 earlier this year and low-value shipments, which I chose to step over since the data on the category. largely unspecified e-commerce and courier shipments, is insufficiently detailed.

This series follows similar series I did for the countries that were, at the time, the nation’s top 10 trade partners and one for the airports, seaports and border crossings that were, at the time, the nation’s top 10 “ports.”

The first article in this series focused on an overview of the top 10 exports. The second looked at the top 10 countries that are markets for U.S. exports and how they differ from our overall trade partners, which would include imports.

The third was about refined petroleum, the top export; followed by one on oil, which ranks second; natural gas, which includes LNG and ranks third; the primary commercial jet category, which ranks fourth; passenger vehicles, at No. 5; computer chips, which actually rank seventh, though at the time this series started, ranked sixth; vaccines, plasma and other blood fractions, which ranked seventh when the series started; motor vehicle parts, the No. 8-ranked U.S. export; and medicines, largely in pill form, which ranked No. 9 when the series began but had slipped to No. 10 by the release of the September data.

In the same way that the low-value shipments category is relatively opaque, so too is the medical instrument category, though far less so. Nonetheless, $11.21 billion of the $26.46 billion total, is categorized as “not elsewhere specified or indicated” — or more than 42 percent.

The top 10 markets are, not surprisingly, advanced economies in North America, Europe, Asia and Oceania (Australia). The top five have already topped $2 billion this year, the top seven having topped $1 billion.

Increases in exports to China, Canada and Japan are all in the single digits while those to the Netherlands, a transshipment hub for Europe, and Mexico have increased 28.48{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} and 12.81{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}, respectively.

Chicago’s O’Hare International Airport, Los Angeles International Airport and what is quite possibly New Orleans International Airport are the three dominant gateways for these exports. (The New Orleans port data comingles air and ocean cargo in the Census Bureau data.) Those three account slightly less than 30{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of the total this year.

The top seven all topped $ billion through September.

How RGB-IR Cameras can enhance medical devices

Diagnostic and therapeutic accuracy has significantly increased as a result of the usage of cameras in the medical device industry. Camera-enabled medical devices, such as retina scanners, automated blood analyzers, digital microscopes, and skin scanners, have greatly decreased medical personnel’s workload and improved the overall patient experience.

Advances in embedded vision and camera technology have largely contributed to this transformation, with new cameras supporting many current medical applications. RGB-IR cameras have been a game changer due to their ability to record IR and visible light data with the same camera without color corruption.

This article discusses how RGB-IR cameras, which can capture images that adhere to the stringent requirements of current medical procedures, improve the performance of medical devices.

RGB-IR cameras and their growing popularity in the medical industry

Before examining how RGB-IR cameras benefit medical and life science applications, it is important to comprehend what they are and how they operate.

Sensors that collect visible and infrared light in the same frame are used in camera modules. This frequently resulted in a deterioration in image quality due to a process known as color corruption. This occurs when the IR data interpolates with the color (or RGB) data and affects the color fidelity of the resulting image.

Two approaches have commonly been employed to address this challenge:

  1. Capture RGB and IR data with two cameras
  2. Using an IR cut filter during the day to prevent IR light from falling on the sensor

In the first case, the system gets bulkier and more difficult to manage. However, the IR-cut filter solves this problem.

The IR cut filter is attached to the lens and is controlled by a mechanical switch. However, this causes wear and tear, dramatically reducing the camera system’s lifetime.

RGB-IR cameras help in this situation.

Technology

Sensors with distinct RGB and IR pixels are used in RGB-IR cameras. Unlike regular camera sensors with the Bayer BGGR pattern, RGB-IR cameras use a new form of CFA (Color Filter Array) with an extra set of pixels that permits only IR light to pass through.

The CFA configuration of an RGB-IR sensor is as follows:

How RGB-IR Cameras can enhance medical devices

Figure 1. Bayer pattern. Image Credit: e-con Systems

RGB-IR filter pattern.

Figure 2. RGB-IR filter pattern. Image Credit: e-con Systems

This innovative technique allows for the separation of RGB and IR data from the camera output. Numerous medical applications benefit from this, including ophthalmology, fluorescence-guided surgery, and remote patient monitoring.

The following are some of the major advantages RGB-IR cameras provide:

  • Increased imaging capability in day and night conditions for continuous 24/7 image and video capture.
  • Smaller form factor due to eliminating the need for two separate cameras to gather RGB and IR data.
  • Improved camera lifetime due to non-mechanical switching between visible and IR imaging. This would also mean that the medical equipment linked with the camera would have a longer lifespan.
  • A distinct IR channel that helps measure the amount of IR light in the RGB component for intelligent color adjustment.

Designing an embedded camera for RGB-IR imaging

As RGB IR imaging necessitates a distinct CFA, the camera system must be precisely developed. This implies that different camera components, such as the sensor, optics, and ISP, must be capable of receiving and processing images suitable for RGB-IR imaging.

The essential parameters to consider when assessing a camera for RGB-IR imaging in terms of its component features are discussed in this section.

Sensor

The camera sensor must include a pixel array that includes both RGB and IR pixels. Various sensor manufacturers, including onsemi and OmniVision, provide RGB IR sensors with specialized RGB and IR pixels.

The pixel pattern of a sensor with RGB-IR capabilities is shown below:

Pixel array of an RGB-IR sensor.

Figure 3. Pixel array of an RGB-IR sensor. Image Credit: e-con Systems

Optics

Most off-the-shelf lenses on the market include an IR-cut filter to restrict IR light from entering during the day. This is because most cameras still employ mechanical switches to shift between day and night settings.

However, RGB-IR imaging requires a lens with a dual bandpass filter. This ensures that light from the visible and NIR spectrums falls on the sensor.

The transmission diagram for a dual bandpass filter is provided below:

Transmission diagram of a dual bandpass filter.

Figure 4. Transmission diagram of a dual bandpass filter. Image Credit: e-con Systems

ISP

The Image Signal Processor (ISP) is one of the most significant components in an RGB-IR camera since extracting the RGB and IR frames from the data given by the sensor requires considerable ISP-side acumen.

e-con Systems, for example, does this through its proprietary algorithm. The company’s engineers also used their ISP expertise to devise an algorithm to remove IR interference from the RGB channels to achieve the correct colors.

One of its other distinguishing features is the ability to tune the ISP to produce processed RGB and IR frames based on the needs of the host platform.

How RGB-IR Cameras can enhance medical devices

Figure 5. RGB window imaging processing. Image Credit: e-con Systems

How RGB-IR Cameras can enhance medical devices

Figure 6. IR window imaging processing. Image Credit: e-con Systems

Key medical applications where RGB-IR cameras are making a wave of change

Some of the benefits of RGB-IR cameras have already been discussed. The following section details how they impact some of the most popular camera-enabled medical applications.

Remote patient monitoring

Remote Patient Monitoring (RPM) devices have benefited the medical industry by minimizing the need for in-person patient monitoring. Using artificial intelligence, RPM systems are now powerful enough to detect patient falls and movements autonomously. These life-changing devices require cameras to collect images and videos to make all of this feasible.

One of the major features of a remote patient monitoring system is that it must be operational around the clock to enable ongoing patient monitoring. This necessitates that the camera functions flawlessly during the day and night. This is where RGB-IR cameras come in.

They allow the RPM device to take images utilizing IR imaging even at night without requiring two separate cameras or a mechanical switch to activate an IR cut filter.

(Left) RGB image during daytime and (Right) IR image during night-time.

Figure 7. (Left) RGB image during daytime and (Right) IR image during night-time. Image Credit: e-con Systems

Image-guided surgery

In surgeries such as laparoscopic cholecystectomy, colorectal surgeries to evaluate bowel viability in hernia cases, mapping of sentinel lymph nodes, etc., fluorescence-guided surgical techniques such as Indocyanine Green (ICG) surgery are used (source: sciencedirect.com).

The dye can become fluorescent when subjected to a wavelength of 750 to 800 nm, which is how ICG surgery works. As a result, the camera utilized must be capable of capturing images in the Near-Infrared (NIR) spectrum.

But why not observe the organs with an RGB camera and an IR light source simultaneously?

The difficulty here is the low spectral resolution. To better grasp this, consider cancer diagnosis as an example application.

In this case, capturing the fluorescent image with a standard RGB camera may not provide enough detail. On the other hand, the IR capabilities of an RGB-IR camera can be utilized to efficiently enhance the cancer diagnosis procedure. At the same time, the RGB data can be used to evaluate any anomalies discovered using the IR output. All of this may be accomplished with a single-camera system.

(Left) RGB image during ICG Surgery and (Right) IR image during ICG Surgery.

Figure 8. (Left) RGB image during ICG Surgery and (Right) IR image during ICG Surgery. Image Credit: e-con Systems

Ophthalmology

The quality of images provided by camera modules inside ophthalmic devices such as fundus cameras and retina scanners substantially influences diagnosis accuracy.

IR imaging is required in these devices to observe sub-retinal characteristics because the deposits appear bright and thicker compared to the optic nerve heads, retinal vessels, and choroidal vessels found in darker regions. Visible light imaging, on the other hand, is essential to ensure that the camera gets the required details of the eye.

This necessitates the use of a single camera that is capable of both visible and IR imaging. As a result, RGB-IR cameras are ideal for such applications. Medical professionals can now efficiently detect and treat eye problems using these new-generation embedded cameras, which provide visible and IR images from the same camera.

Final words

As detailed above, RGB-IR cameras have numerous advantages and are well-suited for various medical applications requiring concurrent RGB and IR imaging. At the same time, specialized NIR cameras are favored for applications that require exceptionally high NIR sensitivity and performance. Before proceeding with camera integration into the device, it is advised that users consult with an imaging professional such as e-con Systems.

About e-con Systems

e-con Systems™ is a leading OEM camera manufacturer with 18+ years of experience and expertise in embedded vision. It focuses on delivering vision and camera solutions to industries such as medical, retail, and industrial. The company’s wide portfolio of products includes MIPI camera modules, USB 3.1 Gen 1 cameras, GMSL cameras, stereo cameras, etc. It has built over 250+ product-based solutions and shipped millions of cameras around the globe. What sets the company apart is its deep expertise in building customized product designs while ensuring rapid prototyping and custom modifications in hardware and software. e-con Systems™ has close partnerships with Sony, ON Semiconductor®, Omnivision, NVIDIA, Xilinx, Socionext™, Cypress, Connect Tech, Toradex, Variscite, Toshiba, Diamond Systems, Avermedia and Texas Instruments.

Giving sight to medical applications:

e-con Systems™ offers end-to-end camera solutions to meet the needs of the medical and healthcare industry. It has a strong foothold in the medical device industry – having empowered clients to integrate unique camera solutions for medical and life science applications in ophthalmology, dentistry, dermatology, laboratory equipment, microscopy, assistive technology, point-of-care technology etc. e-con Systems also has a solid track record of working with the medical device industry leaders such as Thermofisher, Idexx, Perkin Elmer, Amwell, Welch Allyn, Seegene and others.”

Sponsored Content Policy: News-Medical.net publishes articles and related content that may be derived from sources where we have existing commercial relationships, provided such content adds value to the core editorial ethos of News-Medical.Net which is to educate and inform site visitors interested in medical research, science, medical devices and treatments.

Researchers propose the tools and frameworks of EBM+ to help overcome the COVID-19 pandemic

In a recent article published in BMJ, researchers proposed the tools and frameworks of mechanistic evidence, sometimes known as evidence-based medicine (EBM)+ combined with traditional EBM, might help overcome the highly protracted coronavirus disease 2019 (COVID-19) pandemic.

Researchers propose the tools and frameworks of EBM+ to help overcome the COVID-19 pandemic
Study: Adapt or die: how the pandemic made the shift from EBM to EBM+ more urgent. Image Credit: CKA/Shutterstock

EBM+ encompasses conceptual tools and quality frameworks from various fields, including complexity science, engineering, and the social sciences, and a more pluralist approach to fetch ‘high-quality’ mechanistic evidence.

Background

Traditional methods, such as randomized controlled trials (RCTs) and meta-analyses, contributed significantly to the science of COVID-19. However, these methods have historically answered simple, focused questions in a stable context, such as those about biomedicine. They have significant limitations when extended to complex situations. In this case, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a novel pathogen, led to chaos across multiple sectors, medical, social, economic, and political dimensions in a fast-changing global context.

SARS-CoV-2 has proved tenacious and shifting. While RCTs and meta-analyses of RCTs remarkably estimated the efficacy of COVID-19 drugs and vaccines, some scholars argue that tackling some of its aspects critically required mechanistic evidence. COVID-19 led to complex situations where multiple variables interacted dynamically with high uncertainty.

Decisions had to be taken in days (urgently), not years, and the consequences of not acting would have been catastrophic (threatening). In such situations, dismissing mechanistic evidence and overvaluing poorly designed or irrelevant RCT findings cost thousands of lives. Overall, the COVID-19 pandemic presented an epistemic opportunity to understand, debate, and embrace EBM+.

About the study

In the present study, researchers argued that while the hierarchy of evidence that places mechanistic evidence at the bottom and meta-analyses of RCTs at the top is a useful heuristic, but inapplicable to all circumstances. There should be enough guidance to apply hierarchy flexibly depending on the nature of the research question and the extent of complexity involved.

Indeed, RCTs are not a panacea; thus, systemic reviews are crucial to interpret primary evidence along with modifications of the hierarchy of evidence to answer contemporary policy questions pertaining to SARS-CoV-2.

Further, the researchers suggested modifications to the hierarchy of evidence for mechanistic evidence. They emphasized combining evidence of mechanisms with probabilistic evidence from clinical trials and non-randomized studies, both comparative and observational, to make a strong case for causality. It’s because a plausible mechanism confirms or denies the stability of the causal relationship across settings.

This exercise could ensure that public health interventions would work as they involve both the upstream causes and the ’causes’ through which interventions might act. For instance, COVID-19 causes included family structures and their interactions, economic and cultural variations, etc., and attitudes, beliefs, capabilities, and personal resources determined whether public health measures worked. Furthermore, the researchers argued that mechanistic evidence is inherently explanatory.

Early in the pandemic, COVID-19 scientific research was prematurely fixed and constrained to a population-intervention (or exposure)-comparison-outcome (PICO) format that narrowed predefined outcomes and suppressed scientific imagination. Such studies estimated infections in the mask wearer(s) in statistical terms. Still, they failed to account for unique patterns of SARS-CoV-2 spread (e.g., overdispersion, indoor predominance), all of which could have pointed at its predominantly airborne transmission.

An RCT randomized 6,024 people advised wearing masks outside the home. Its results showed infection with SARS-CoV-2 in 42 and 53 people (1.8{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} and 2.1{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}) of the intervention and control arms, respectively, i.e., statistically insignificant. However, EMB supporters argue and evidenced that wearing masks in public does not substantially reduce infection.

The Cochrane Database of Systematic Reviews encouraged policy-makers to adopt the precautionary principle based on the findings of this flawed study because of the urgency of the situation. However, an EBM approach would have accounted for studies elucidating the mechanism(s) by which masking might work. For instance, evidence from:

i) real-world case studies and mathematical modeling studies supporting airborne route of transmission of SARS-CoV-2

ii) Engineering studies showing the filtration properties of different masks

iii) Psychological and socio-cultural evidence of whether people wear masks

Delivering public health interventions and ensuring they are implemented, for instance, face masking, is a complex phenomenon. It has multiple components acting interdependently and individually at multiple levels. Masks could be homemade or produced to formal technical standards. People may mask as socially expected, organisationally required, or legally mandated.

Overall, its adequate implementation is complex in real-world settings for multiple social and behavioral reasons. Thus, complex systems require a new paradigm with designs that could capture dynamic change(s), simultaneously accommodating non-linearity and embracing uncertainty. In support of structural evidence, the researchers discussed how engineering designs account for physical and technical properties and capabilities, social needs, and assessment of impact with the example of personal protective equipment (PPEs).

The use and impact of PPEs are influenced by the quality of indoor air. Yet, an RCT comparing these products with less effective protection to ‘prove’ their value in protecting against chemical contamination in a lead smelter makes no sense. All required is robust certification systems, standards, and workplace usage protocols for PPEs. Currently used PPEs have already proven a boon against occupational hazards for millions of healthcare workers worldwide.

Professor Susan Michie, an adviser to UK’s Scientific Advisory Group on Emergencies, proposed the capability-opportunity-motivation-behavior model. This model helped explain why people prefer or do not prefer wearing a mask. In some cases, they may lack key knowledge (e.g., they may not know whether cloth masks are as effective as surgical masks) or may physically not want to because they are not a good fit. Likewise, they might lack motivation (e.g., conscious beliefs) or opportunity (e.g., employer bans masks). Nevertheless, not exploring these wider influences might produce misleading findings by experimental studies.

Conclusions

In the present study, the authors emphasized more on other sources of evidence, especially mechanistic evidence, to manage the complex and fast-changing COVID-19 pandemic. As the debate regarding EBM+ continues, they hope to contribute further articles on how an EBM+ approach could enhance contribution to pandemic science.

3 Medical Instruments Stocks With Potential to Outperform

In recent years, the medical instrument industry, part of the wider Medical sector, has seen a transformation in the nature of its business, leading to higher research and development activities for developing cutting-edge technologies. The industry’s landscape changed further with the onset of the COVID-19 crisis that put robotic and remote services in the limelight. Although the majority of economies have opened up following strict lockdowns in the past couple of years, the demand for robotic and remote services is likely to remain.

However, the industry is currently facing several challenges, including supply-chain challenges, a shortage of semiconductor chips and global inflationary pressure. These developments have resulted in an extremely tough situation related to raw material and labor costs as well as freight charges. The shortage of semiconductor chips has resulted in a delay in the production of commercialized products.

Although the industry faced headwinds, a few medical instrument companies were able to maintain their recovery trend in the first nine months of 2022. Moreover, the ongoing macro headwinds are likely to improve in 2023, which should help top-line and bottom-line growth.

Here we discuss three medical instruments stocks — ShockWave Medical SWAV, iRadimed IRMD and Tactile Systems Technology TCMD — which are likely to outperform the industry going forward amid an improving world economy and easing macro headwinds. These stocks carry a Zacks Rank #2 (Buy) each. These stocks also have a Momentum Score of A or B, which indicates that these would be good stocks for momentum investors based on recent price changes and earnings estimate revisions. Meanwhile, the underperformance of iRadimed and Tactile Systems in the past six months compared with the Zacks Medical – Instruments industry may lead to a rally in these stocks on the back of strong fundamentals. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

3 Medical Instruments Stocks With Potential to Outperform
Image Source: Zacks Investment Research

ShockWave Medical

ShockWave Medical has a Momentum Score of B. The Zacks Consensus Estimate for earnings has moved 12.1{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} and 4.1{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} north for 2022 and 2023, respectively, in the past 60 days.

The increased adoption of coronary IVL in the United States, continued sales force expansion, growing international expansion and higher adoption of Shockwave products are likely to boost the company’s performance. The company’s strong global growth highlights the significant clinical need for a better calcium treatment and how well the team at ShockWave Medical is addressing the same with IVL.

ShockWave Medical, Inc. Price

ShockWave Medical, Inc. Price

ShockWave Medical, Inc. price | ShockWave Medical, Inc. Quote

iRadimed

iRadimed has a Momentum Score of B. The Zacks Consensus Estimate for earnings has improved 2.9{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} for 2022 in the past 60 days. The consensus estimate for 2023 earnings stands at $1.20 per share, implying year-over-year growth of 13.2{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}.

iRadimed is a leader in the development of innovative magnetic resonance imaging (“MRI”) medical devices and the only known provider of a non-magnetic intravenous (“IV”) infusion pump system and non-magnetic patient vital signs monitoring systems designed for use during MRI procedures. During the third quarter, the company reported 23{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} growth in revenues and 35{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} in earnings from the year-ago period. The company stated that significant demand for its IV pump and patient monitor product lines continued during the third quarter. The company has a strong bookings growth that continued to add to its extensive backlog and is likely to drive revenues for the remainder of 2022 and 2023.

iRadimed Corporation Price

iRadimed Corporation Price

iRadimed Corporation price | iRadimed Corporation Quote

Tactile Systems

Tactile Systems has a Momentum Score of A. The Zacks Consensus Estimate for loss has narrowed 12.6{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} for 2022. The consensus estimates for 2023 loss stood at 10 cents, implying a year-over-year improvement of 87.3{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}.

The medical technology company develops medical devices for the treatment of chronic diseases at home. During the third quarter, it reported 24{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} growth in revenues and loss narrowed 35.3{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} year over year. Strong demand for its products during the quarter led the company to raise its revenue guidance by approximately 1.5{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} as measured at the midpoint of the guided ranges. Meanwhile, its settlement of a pending securities class action lawsuit earlier this month removed an overhang.

Tactile Systems Technology, Inc. Price

Tactile Systems Technology, Inc. Price

Tactile Systems Technology, Inc. price | Tactile Systems Technology, Inc. Quote

Zacks Names “Single Best Pick to Double”

From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.

It’s a little-known chemical company that’s up 65{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.

This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} in little more than 9 months and NVIDIA which boomed +175.9{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} in one year.

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iRadimed Corporation (IRMD) : Free Stock Analysis Report

Tactile Systems Technology, Inc. (TCMD) : Free Stock Analysis Report

ShockWave Medical, Inc. (SWAV) : Free Stock Analysis Report

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Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

8-year-old Ukrainian refugee reunited with vital medical equipment

“It’s important for Mark’s mobility and quality of life that he has these. They were impossible for us to replace because what costs $600 in Ukraine, costs $6,000 here in Canada.” — Bogdan Motorenko

8-year-old Ukrainian refugee reunited with vital medical equipment
Yelzaveta Motorenko, her eight-year-old son Mark and her husband Bogdan were all smiles on Saturday as Mark was reunited with some vital medical equipment that his family had been forced to leave behind when they fled Ukraine in late February. Photo by Francis Georgian /PNG

Mark Motorenko let out joyful squeals Saturday morning as Captain Doug Petti lifted him into a fire truck at Burnaby’s hall No. 1. 

It was the first time the eight-year-old Ukrainian refugee had seen inside such a vehicle. Normally, he cowers if sirens from the truck blast through his new Burnaby neighbourhood.

“The sounds scare him,” said his mother Yelyzaveta, 26, who fled from Kyiv to Canada five months ago with her husband Bogdan, 28.

The family came to Metro Vancouver seeking a better life for their son, who lives with cerebral palsy.

After Mark was lifted back down from the truck and into his wheelchair, he was presented with five large gifts by Petti, Burnaby Mayor Mike Hurley and Peter Julian, the MP of New Westminster-Burnaby.

The group invited the family to the firehall Saturday for a surprise.

Underneath the wrapping paper was the standing device Mark had used back home to strengthen his muscles, which are affected by a developmental disease that affects his movement, balance and posture.

Mark Motorenko smiles for the camera on Saturday as he was reunited with some vital medical equipment that his family had been forced to leave behind when they fled Ukraine in late February.
Mark Motorenko smiles for the camera on Saturday as he was reunited with some vital medical equipment that his family had been forced to leave behind when they fled Ukraine in late February. Photo by Francis Georgian /PNG

The child smiled with glee to see the return of remnants of his old life. The other gifts were his walker and tricycle.

“It’s important for Mark’s mobility and quality of life that he has these,” Bogdan said. “They were impossible for us to replace because what costs $600 in Ukraine, costs $6,000 here in Canada.”

Since war broke out where they lived in Kyiv in February, both parents agree that their son hasn’t quite been himself.

Before Russia’s invasion, Mark had made progress with daily physiotherapy and had begun to stand on his own and took his first step. But since Feb. 25, when the blast of a nearby missile awoke the child in terror, he has been reluctant to move.

“He is very scared,” Yelyzaveta said. “That’s why we left, he was so nervous every night and would cry all night about the war.”

The Motorenkos fled the Ukrainian capital days after the conflict began in late February. They left their belongings behind.

By September, settled in the Lower Mainland, they reached out to Julian’s office in desperate need of retrieving their son’s specialized medical equipment.

“It would cost thousands of dollars to ship their special needs child’s medical equipment from Ukraine to Canada,” the MP said Saturday in a news release. “It was impossible for a refugee family, fleeing from a war zone, to come up with such an enormous amount.”

So, the Burnaby Firefighters Charitable Society quickly stepped in to cover the costs.

“We’re just happy to get this equipment back into Mark’s hands,” Petti said.

The family plans to haul the equipment home, to Burnaby, where they live with sponsors Susan Millar and Deepak Sahasrabudhe.

Julian said Saturday that hundreds of other Burnaby residents have offered up their homes to Ukrainian refugees this year.

“Tragically, as this brutal invasion continues we will see more families coming.”

The MP acknowledged the serious challenges the refugees face upon arriving in Canada. “My office is hearing some Ukrainian families here are struggling to put food on the table right now.”

Julian said, “the important thing is that as they come, they are being supported by their new community — as Mark has.”

Yelyzaveta hopes that her son will soon find the courage to try to walk again, with help of the equipment.

“We’re thankful for all the Canadians who have helped us and Mark,” Yelyzaveta said.

“If he is happy, we are happy.”

sgrochowski@postmedia.com

twitter.com/sarahgrochowski

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Despite successes, lack of regulation raises concerns over medical devices

Janice Berger isn’t a big fan of bowling shoes.

“Oh my gosh, who knows whose dirty feet have been in those shoes,” Berger said.

But sporting a pair at Signature Lanes in Elkhart, Berger is just glad to be able to lace them up on her own. It wasn’t long ago the senior from Goshen couldn’t put on her own shoes. Much less bowl.

Chronic pain has kept Berger from bowling for the last seven years.

“I couldn’t bowl, I couldn’t ride my bike,” Berger said. “I couldn’t enjoy my grandchildren. So it is frustrating when you are so tired of pain there is absolutely no joy in your life.”

She has diabetic neuropathy; nerve damage in her feet caused by diabetes. It affects 28{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of all diabetic patients according to the National Library of Medicine.

Berger was at the point she was willing to do anything to stop the pain.

“I just thought, I’m going to start with a podiatrist and work my way up to God if that’s what it takes,” Berger said.

You couldn’t see it even while Berger grabbed a bowling ball, rolled it down the lane, or watched her first gutter ball in years; but sitting in the base of her spine is a Nevro HFX. A spinal cord stimulator stopping the pain. She had it implanted in November, 2021 after trying medications, therapy, and other methods that never worked.

“Last time I talked to her, she told me she had 100{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} relief. She was smiling the whole time. She was extremely happy,” said interventional pain specialist Dr. Jerry Grewal.

Dr. Grewal implanted Berger’s Nevro HFX, which is the first time it’s been used for diabetic neuropathy.

“Hopefully patients will improve, their quality of life will get better, their pain will decrease, and they can be less reliant on medications,” Dr. Grewal said. “And hopefully they don’t have to be on opiates long term.”

Jeanne Lenzer, author of The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It, worries some patients don’t consider that medical devices have their own side effects which can be serious.

She’s spent years studying the medical device industry.

“It’s a wild west out there,” Lenzer said. “Devices are the wild west.”

About one in ten Americans will have a medical device implanted in their lifetime. But less than half a percent of these devices have been tested in rigorous clinical trials, according to the American Medical Association Journal of Ethics.

There are at least 500 FDA consumer complaints over the last five years following a Nevro Senza device implant. Reported issues include infections, sepsis, shocking sensations, and numbness.

In these cases, no issues were found with the device. But it’s the manufacturer itself investigating whether the device is at fault.

“We’ve [implanted], between the trials and everything else, almost 100,000 of these devices. And we very carefully track any reports of adverse events. We’re required to,” Nevro chief medical officer Dr. David Caraway said.

Dr. Caraway points to an 18-month trial showing Nevro’s spinal cord stimulators leading to pain relief for nearly three quarters of patients.

“We’re really focused on evidence building and providing the safest and most effective therapies that are out there,” Dr. Caraway said.

And the Nevro HFX went through the FDA’s more stringent pre-market approval process.

But 82{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of devices go through 510(k) approval, which requires no clinical data. According to a study published in the Journal of the American Medical Association, 510(K)-approved devices make up 97{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of medical device recalls.

“A lot of people think that the FDA actually tests things. They don’t do any testing at all,” Lenzer said. “What they do is they ask the manufacturer to provide their information. And that’s what they go on.”

Patients considering a medical device can look up reported issues on the FDA database. Lenzer recommends researching complaints, considering possible side effects, and weighing them against the intended benefit. Patients should also ask their medical provider how often they’ve implanted the device.

So far, Berger hasn’t had any issues.

“It’s a dream come true,” Berger said.

And even if it’s not helping her score on the lanes, she is just glad to be back in the game.