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Medical Device

Cancer test maker Dermtech to cut 100 jobs, explore strategic options

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Dive Brief:

Dermtech will lay off about 100 employees, or 56% of its workforce, to preserve cash. The San Diego-based company, which makes a skin patch to test for melanoma, is also exploring strategic alternatives, it said Thursday in a regulatory filing.
Strategic alternatives that may be considered include an acquisition or a sale of assets. The staff reduction is part of a broader effort to “significantly reduce” operating expenses and maximize shareholder value, Dermtech said.
As a result of the announcement, the company said it will not hold a first-quarter earnings conference call.

Dive Insight:
Dermtech posted a net loss of $100.9 million in fiscal 2023 and reported its billable sample volumes fell 11% in the fourth quarter. It had cash and equivalents, restricted cash and short-term marketable securities of $59.3 million as of Dec. 31.
The company’s noninvasive test, which collects cellular material from the skin’s surface, is designed to detect genomic markers associated with melanoma and differentiate benign lesions from those at higher risk.
The test has a 99% negative predictive value, according to the company, which means that with a negative test result, there is a 99% probability that the lesion is not melanoma. The laboratory-developed test is not reviewed or approved by the FDA.
The company’s board of directors approved the restructuring plan on Thursday. The workforce reduction is expected to be completed by the end of the second quarter.
Dermtech will record one-time charges in the second quarter of about $1.6 million related to the job cuts, including severance payments, employee benefits, outplacement services and other costs.
A special committee of the board hired TD Cowen to conduct the strategic review process, and AlixPartners has been hired as a restructuring adviser.
On April 15, Dermtech received a written warning from Nasdaq that the company could be delisted from the stock index for falling below the required minimum of $1 per share.

Harnessing the Potential of Digital Quality: Transforming Manufacturing Outcomes for Long-Term Success

Harnessing the Potential of Digital Quality: Transforming Manufacturing Outcomes for Long-Term Success     Automation and digitization of quality processes are becoming integral to advanced manufacturing operations. Medical manufacturers are using it more often to improve efficiency, reduce costs, and enhance product quality. MTI recently discussed how this digital transformation is improving MedTech manufacturing quality with …

Harnessing the Potential of Digital Quality: Transforming Manufacturing Outcomes for Long-Term Success Read More »

Intuitive’s rollout of new da Vinci 5 robot steals Q1 spotlight

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By the numbers

Q1 revenue: $1.89 billion
11.5% increase year over year

Q1 net income: $544.9 million
53.4% increase year over year

Intuitive Surgical’s robot procedures and system placements grew at a healthy clip in the first quarter, but a focus on launch plans for the da Vinci 5 platform dominated the company’s earnings call.
Surgeons have now completed their first cases using the system, which gained Food and Drug Administration clearance last month, and the new robot is drawing positive early reviews for improved precision, efficiency, ergonomics, imaging and analytical capabilities, CEO Gary Guthart said on the Thursday call.
Eight of the next-generation systems were placed with customers during the quarter.
System placements may be choppy in the coming months, however, as da Vinci 5 is rolled out on a limited basis, Intuitive executives cautioned.

The phased launch of the much-anticipated da Vinci 5, first announced last month, will extend through this year and into early 2025, Guthart said, as the company concentrates on ensuring supply chain quality and incorporating customer feedback and planned updates.
“We’re working hard to optimize our supply chains and manufacturing capabilities for da Vinci 5 components. We will remain in our measured rollout as we stabilize supply and respond to customer input,” Guthart said.
Some customers interested in da Vinci 5 may wait for adequate supply before acquiring the robot or opt for a fourth-generation system with an upgrade arrangement, the executives said.
“It’s really hard for us, sitting where we are today, to predict the depth and timing of a replacement cycle,” the CEO added, in response to an analyst’s question. Much of the discussion in the question-and-answer portion of the call centered on reaction to da Vinci 5, including the potential of the robot’s new technology that simulates the feeling of force on tissue.
Guthart said the sensing instruments are generating great interest among surgeons, and the company is studying the implications for procedures as well as the training of doctors new to robotics.
Intuitive also faces supply constraints affecting adoption of its Ion lung biopsy system.
The company has made progress resolving supply challenges affecting Ion’s catheter and vision probe, but more work remains to be done, Guthart said. The FDA earlier this month cleared design changes to the catheter that will alleviate some of the supply constraints while improving the economics of the device, he said.

Procedure outlook raised
Intuitive raised its forecast for full-year procedure growth to a range of 14% to 17%, from its prior outlook of 13% to 16%.
In the first quarter, procedures using the da Vinci robot grew about 16% worldwide, compared with the year-ago period, when a backlog of cases remaining from the COVID-19 pandemic elevated patient volumes, Intuitive executives said. Bariatric procedure growth in the U.S., which has been hurt by patient interest in new weight-loss drugs, continued to moderate and was flat in the quarter, compared to a year ago, the company said.
Intuitive placed 313 da Vinci systems, compared with 312 in the first quarter of 2023.
With strong early clinician feedback on da Vinci 5, the system’s broader launch could lift investors’ earnings expectations for 2025 and 2026, BTIG analyst Ryan Zimmerman said in a research note.
“Going into results, we thought that the Street was too low on systems (with the idea being that hospitals would hold off ahead of [da Vinci 5]) but we believe with the option to upgrade and a healthy capex environment, system demand is proving more robust,” Zimmerman wrote. “Still, we think results take a backseat to [the] focus on [da Vinci 5].”

Discover Reeva FT: Revolutionizing Wound Covering for Healthcare Pros

Reeva FT is confirmed by the FDA Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the PHS Act as defined in 21 CFR Part 1271. Reeva FT is a lyophilized human placental-based allograft consisting of amnion and chorion membranes, with the retention of the intermediate layer.
Reeva FT
Legacy Medical Consultants (LMC) announces its newest product portfolio addition with the recent Q code approval for Reeva FT™, a terminally sterilized, full-thickness, dual-layered amnion/chorion allograft designed for covering and protection during advanced wound treatment. 

“There is a critical need in the wound care space for these advanced allograft products,” says Jonathan Knutz, CEO of Legacy Medical Consultants, “and we continue to deliver solutions that innovate while advancing a well-established and proven medical technology.” 

What Is Reeva FT?

Reeva FT is a lyophilized human placental-based allograft consisting of amnion and chorion membranes, with the retention of the intermediate layer. Reeva FT provides a protective covering to the surrounding environment in acute and chronic wounds. The graft also introduces a naturally derived extracellular matrix that acts as a scaffold to support native tissue during treatment. Reeva FT hydrostatically adheres to wounds and has a 5-year shelf life when stored at ambient temperature.

Sizes

Reeva FT is offered in a variety of sizes: 2×2 cm, 2×3 cm, 4×4 cm, 4×6 cm, 4×8 cm, and 10×15 cm. Reeva FT is confirmed by the FDA Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the PHS Act as defined in 21 CFR Part 1271.

In the most recent HCPCS announcement by CMS, Reeva FT was assigned a new HCPCS Level II code of Q4314.

What Kind of Equipment is Used to Analyze DNA?

Or profile, of a DNA sample, must be compared, either to DNA from a suspect or to a DNA profile kept in a database, to identify the sample’s owner. • Isolating DNA from a sample containing the needed DNA of unknown origin, as well as isolating DNA from the test sample (e.Below are a few basic processes followed throughout DNA testing. The general procedure entails: • Isolating DNA from a sample containing the needed DNA of unknown origin, as well as isolating DNA from the test sample (e.g., blood, semen, skin tissue, or saliva) from a known individual.

• Processing the DNA to obtain test results

•  Determining the variations in the DNA test results (or types) from specific regions of the DNA

• Comparing and interpreting the test findings from the unknown and known samples to have a conclusion.

Delve into the world of DNA analysis and uncover the equipment used in this intricate process. For a comprehensive understanding of your genetic makeup, don’t miss the opportunity to get this premium DNA Test, which offers valuable insights into ancestry, health traits, and more.

How is DNA Analyzed?
The DNA sample is taken to a forensic laboratory. These labs differ significantly in terms of how they have been organized and the kind of analyses they provide. Many laboratories can test nuclear DNA, which is the copy of DNA found in every cell’s nucleus. However, specialized procedures such as mtDNAanalysis and Y-chromosome among others are only available in a few sophisticated labs. Let us take a closer look at a few of these strategies.
Restriction Fragment Length Polymorphism (RFLP)
One of the first forensic approaches for analyzing DNA is restriction fragment length polymorphism (RFLP). It measures the length of DNA strands with repeating base pairs. Variable number tandem repeats (VNTRs) is a type of repetition that can occur anywhere between one and thirty times.
• Process: To do RFLP analysis, researchers must dissolve DNA in an enzyme that breaks down the strand at specific locations. The length of each strand of DNA is affected by the number of repeats. The investigators compare the sizes of the strands in the samples. RFLP analysis requires a piece of uncontaminated DNA for the best and accurate results. 
Short and Tandem Repeat Analysis (STR)
RFLP analysis is slowly being phased out in favor of short tandem repeat (STR) analysis in many laboratories. One of the most significant benefits of this technology is that it can begin with a considerably smaller quantity of DNA. 
STR analysis evaluates the frequency of repeat of base pairs in specific segments on a DNA strand after DNA amplification. Repeats of two, three, four, or five base pairs are known as dinucleotide, trinucleotide, tetranucleotide, or pentaLetnucleotide repeats. Investigators frequently look for tetranucleotide or pentanucleotide repetitions in PCR-amplification samples because they offer high accuracy.
• Process: The sample is amplified using a polymerase chain reaction technique. PCR copies DNA similarly to how DNA duplicates itself in a cell, yielding nearly unlimited amounts of genetic material by using agarose gel media.
Importance of DNA Analysis:
DNA analysis’s primary goal is to create a visual representation of DNA. A DNA “image” resembles a fingerprint taken from a flat surface with columns of dark-colored parallel bands, and it is unique to every individual. The DNA “fingerprint,” or profile, of a DNA sample, must be compared, either to DNA from a suspect or to a DNA profile kept in a database, to identify the sample’s owner.
Equipment Used to Analyze the DNA:
DNA testing investigates several loci in human DNA when investigating possible a match. Human DNA differs by around one-tenth of one percent, or roughly three million base pairs (a person has three billion in total); therefore, you must identify highly variable regions. Sterile cotton swabs are the most commonly used tools to collect samples because they limit the possibility of contamination. However, you can study any fluid or tissue from any item or object. Some of the lab equipment used in DNA analysis include: 
Thermostatic Cycler:
There are different equipment used for each procedure. A thermal cycler holds a block of tubes carrying PCR mixture. It raises or lowers the block’s temperature in pre-programmed steps, as used in PCR (polymerase chain reaction), a common technique in DNA analysis. This splits and amplifies the DNA, resulting in multiple copies of the same strand. The approach is used to evaluate even little or deteriorated materials. The DNA, on the other hand, must still be tested.
DNA Analyzer:
To detect particular nucleotide sequences, a DNA probe labeled with a radioactive molecular marker may bind to a complementary DNA sequence in the sample resulting in a unique pattern for each person, which can then match a different sample. 
It is more likely that scientists will find a match if there are more loci present. The recommended number is approximately four to six probes. After that, the amount of time and money spent on testing skyrockets.
Dyes and Electric Fields:
After amplification, another approach referred to as short tandem repeat (STR) is implemented. This process involves the use of either gel electrophoresis or capillary electrophoresis. Both methods use an electric field to see any repetitive DNA sequences across 13 distinct loci. Researchers can use silver staining, intercalating dyes like ethidium bromide, or fluorescent dyes to make the sequences more visible. The chances of two people having an exact match are roughly one in a billion, which means only approximately six or seven people on the planet will have a match.
DNA Isolation Kits:
Most molecular biology procedures, such as cloning, library preparation, and sequencing, need plasmid DNA purification as a starting material. There are ready-to-use plasmid purification kits and reagents to extract high-quality plasmids from bacterial and fungal cell types, such as those offered by Modern Biology. Select the purification scale (from miniprep to gigaprep), format (spin, vacuum, or magnetic), and compatibility with automated systems using the specified filters. 
DNA test kit investigates several loci in human DNA when investigating possible a match. Human DNA differs by around one-tenth of one percent, or roughly three million base pairs (a person has three billion in total); therefore, you must identify highly variable regions.
Polymerase Chain Reaction Machines (PCR)
When you’re able to make several copies of a DNA segment, you can conduct various tests at the same time. You may, for example, run one test after another without causing the original sequence to be damaged. You may create a control segment and then compare it to other segments. A single tissue sample may be submitted, and numerous test results can be obtained. This is made possible by the polymerase chain reaction machine, which is why it is standard equipment in DNA analysis laboratories. 

Medical Grade, Premium Standing Solutions Drastically Improve Employee Comfort, Support, Productivity and Morale While Reducing Fatigue, Stress and Ailments | By Amy Hester, PhD, RN, BC, FAAN, Chairwoman and CEO, HD Nursing, & Daniel Bouzide, Founder and President, WellnessMats

Moreover, the cycle of fatigue contributes to nagging ailments, sick days, long and short-term injuries as well as a higher turnover rate, adding pressure to an already strained healthcare environment and disrupting the continuity of patient care. With reports indicating that up to 70% of healthcare workers are experiencing high stress and burnout, industry observers are concerned that these issues are not only taking a toll on personal health but are also hindering patient care.Occupational fatigue in the healthcare sector impacts not just the well-being and efficiency of medical professionals across the board, but also their ability to perform tasks with the necessary precision and care that is required. The healthcare environment, known for its high stakes and demanding nature, cannot afford the lapses in performance and attention to detail brought on by fatigue.This issue is particularly pronounced among nurses, who face intense physical and mental demands in their day-to-day roles.
The Rising Challenge of Occupational Fatigue in Healthcare
With reports indicating that up to 70% of healthcare workers are experiencing high stress and burnout, industry observers are concerned that these issues are not only taking a toll on personal health but are also hindering patient care. The physically demanding nature of healthcare work, characterized by long hours, night shifts and the emotional toll of patient care, places an enormous burden on all personnel – particularly nursing professionals. In this pressured environment, replete with labor shortages and employee retention difficulties, the introduction of cost-effective, medical-grade anti-fatigue mats as a premium standing solution helps hospitals, healthcare systems and facilities to effectively address these challenges. A comprehensive analysis, encompassing a wide range of studies, sheds light on the extent of this challenge:
Prevalence of Work-Related Musculoskeletal Disorders (WMSDs)
A significant review found that a staggering 77.2% of nurses experience WMSDs within a year. This high incidence rate highlights the physical strain of nursing duties, which often include extended periods of standing, and underscores the need for effective interventions.
Impact on Physical and Mental Health
The disorders most commonly affect the lower back, legs, neck and shoulders, indicating the areas most at risk due to the physical demands of nursing. Beyond physical discomfort, these conditions profoundly impact the mental health of nurses, emphasizing the dual facets of occupational fatigue.
Association with Medication Administration Errors (MAEs)
Further analysis from thirty-eight studies indicates that fatigue is a contributing factor to MAEs and near misses. This association is troubling, given that such errors pose a grave threat to patient safety and reflect the critical need to address fatigue in healthcare settings.
Cognitive Performance and Patient Safety
The link between occupational fatigue and reduced cognitive performance — including attention and vigilance — is directly associated with poor nursing performance. This connection further emphasizes the risk that tired healthcare professionals pose to patient safety.
Enhancing Healthcare Environments with Ergonomic, Premium Anti-Fatigue Mats
Premium Anti-Fatigue mats offer a profound solution to these challenges, symbolizing a tangible expression of management’s concern for the health of professionals. Designed for the high-traffic nature of medical settings, these mats are engineered to encourage subtle leg movements, boosting circulation and alleviating pressure on the joints and spine.
This innovation not only minimizes fatigue but also plays a crucial role in preventing chronic musculoskeletal disorders, significantly reported by nursing professionals. Moreover, the cycle of fatigue contributes to nagging ailments, sick days, long and short-term injuries as well as a higher turnover rate, adding pressure to an already strained healthcare environment and disrupting the continuity of patient care.
Furthermore, the psychological benefits of working in a more comfortable and thoughtfully designed space are immense. Such improvements convey a strong message of appreciation to the workforce, leading to increased morale, higher job satisfaction and a stronger commitment to patient care.
The Importance of Choosing Professional Ergonomic Solutions
In distinguishing between professional-grade ergonomic, Premium Standing Solutions and inferior products, it’s critical to understand that not all mats are created equal.
Professional ergonomic mats are designed with healthcare settings in mind, incorporating antimicrobial properties essential for maintaining sterile conditions. In contrast, underperforming mats may harbor bacteria and offer insufficient support, posing risks rather than providing benefits.
What to look for:

Choose a “Best-in-Class” Premium anti-fatigue product
Complete comfort and support wherever one stands
Superior durability and longevity
Smooth, sealed surface and bottom with antimicrobial properties
A Warranty that reduces mat replacement
Professional Grade Construction that guarantees the beveled edges will never curl reducing dangerous trip hazards
Meticulous craftsmanship that ensures the mats will never separate and always maintain their buoyancy
Commitment to “Made in the USA” construction
Exemplary performance throughout various industries
Example: WellnessMats are regarded as the gold standard for almost 30 years

Prioritizing Employee Well-being as a Strategic Healthcare Investment
Allocating resources towards enhancing employee well-being is a strategic decision that addresses immediate and long-term challenges. This approach not only mitigates worker fatigue but also reduces the broader financial and operational costs associated with high employee turnover and patient safety incidents. Providing Premium Anti-Fatigue Mats is often the most economical way to minimize these avoidable expenses. By prioritizing investments in the work environment, healthcare leaders can foster a positive culture that respects and values the contributions of nursing professionals, leading to significant improvements in patient care.
Acknowledging the complex interplay between various factors contributing to occupational fatigue is the first step, Healthcare institutions can begin to develop effective strategies to safeguard the well-being of their workforce and enhance the quality of patient care.
Beyond physical interventions, addressing the ergonomic challenges in healthcare necessitates a multifaceted approach. This includes ergonomic assessments, training and systemic changes to manage workloads and promote a culture of safety. By investing in comprehensive wellness strategies, healthcare facilities demonstrate a deep commitment to their staff’s well-being, enhancing team cohesion, morale and ultimately, patient care quality.
Looking Forward: A Call to Action for Healthcare Leaders
The integration of medical-grade anti-fatigue mats into healthcare settings is more than an ergonomic intervention: it’s a visible sign of an institution’s dedication to the well-being of its employees and the safety of its patients. This decision reflects an understanding of the intricate link between the health of the workforce and the quality of patient care delivered. By adopting such innovative solutions, healthcare leaders take a crucial step toward creating a healthier, more productive and resilient healthcare environment.
Incorporating these ergonomic solutions, grounded in evidence-based best practices for patient safety, not only addresses the pressing issue of occupational fatigue among healthcare workers but also advances the standards of patient care. By focusing on the health and well-being of healthcare workers, facilities not only improve their operational performance but also demonstrate a firm commitment to excellence in patient care.Healthcare management teams can provide these standing solutions as a way of demonstrating their appreciation of the tireless work performed by employees. Professionals will appreciate the unmatched comfort, support and durability of these products which translates into improved employee safety, productivity and morale.
Amy Hester, Phd, Rn, Bc, Faan, Chairwoman And Ceo, Hd Nursing
About Dr. Amy Hester, PhD, RN, BC, FAAN, Chairwoman and CEO, HD Nursing: Amy has 25 years of nursing experience including over a decade of med/surge and neuro nursing followed by unit management and hospital administration. In 2015, she earned a Doctor of Philosophy in Nursing Science and has since published and spoken extensively on the subject of falls and injury prediction and prevention. She retired from UAMS in 2018 after 26 years of service to dedicate her time fully to HD Nursing. She is adjunct faculty at UAMS College of Nursing. As an entrepreneur, she mentors others to help them with their own endeavors. Amy also serves as the Chair of the HD Nursing Board of Directors.
&Amp; Daniel Bouzide, Founder And President, Wellnessmats
About Daniel Bouzide, founder and president, WellnessMats: A self-driven entrepreneur dating back to the 1980’s, Daniel Bouzide has always had a passion for innovative business opportunities. While not every venture has turned to gold, most have been successful, enjoyable, and highly educational. Determination and resiliency, coupled with creativity, have always been the driving factors to Daniel’s success.
In 2005, Daniel founded Smart Step Therapeutic Flooring. He saw a tremendous void in the ergonomic standing category whereas better/best products were simply not available. As a one-man operation, he started a Michigan-Based company and began selling the best anti-fatigue mat on the marketplace.
The initial successes came quickly, and soon a professional sales team followed. In 2007, Smart Step merged with Meramec, the USA-based Manufacturer in Missouri and formed American Pro Marketing. This partnership has proven tremendously successful and has allowed both parties to soar as corporate America began understanding and appreciating the values in Premium Standing Solutions.
To date, the American Pro Marketing Brands that include Smart Step, WellnessMats and others, are the leaders in the Premium Anti-Fatigue Mat Category. With eight divisions, APM proudly produces 1.2 million Premium Standing Solutions each year in St. Louis, MO.

Spinoffs, sales and tuck-ins top medtech deal priorities: Moody’s

Dive Brief:

Medical device companies will continue to spin off and sell assets to improve their financials and increase their focus on core activities, Moody’s Ratings analysts said in a report Thursday.
A series of companies including 3M and Zimmer Biomet have recently spun off assets, and analysts predict the trend will continue, starting with Baxter and Edwards Lifesciences deals that are expected to close this year.
The analysts said tuck-in acquisitions in high-growth, high-margin areas will remain the focus for M&A, but they see potential for larger deals if interest rates fall significantly.

Dive Insight:
The analysts listed eight spinoffs and sales, including the pending Baxter and Edwards deals, since early 2022 among the companies they cover. Companies are pursuing the transactions to “bolster underlying growth rates and/or margins, improve focus on and investment in core activities and monetize assets to facilitate deleveraging vis-à-vis accelerated debt payoffs,” the analysts wrote.
Baxter plans to split from its kidney care unit in the second half of the year, either by spinning off the business or selling it to private equity buyers. The analysts said the plan is part of Baxter’s attempts to “simplify its business and focus on innovation such as connected-care technological solutions.”
Edwards also plans to complete a spin off in the second half of the year. The company is working to turn its critical care unit into a standalone business. The analysts see upsides and downsides, saying the deal “would likely reduce the company’s diversity and scale” but allow Edwards to focus on transcatheter aortic valve replacement and new investments in interventional heart failure technologies.
The analysts cited Boston Scientific’s planned $3.7 billion acquisition of Axonics as an example of the sort of tuck-in acquisition they expect to see companies pursue in 2024. Stryker and Zimmer Biomet are likely to use free cash for R&D and acquisitions, the analysts said. Bolt-on acquisitions could accelerate growth “in faster-growing parts of the market such as technological capabilities.”
Johnson & Johnson has shown an appetite for larger deals, recently following up its $16.6 billion buyout of Abiomed with an agreement to acquire Shockwave Medical for $13.1 billion. The analysts said there could be more Shockwave-sized takeovers “if interest rates substantially decrease.”

Scopio Labs wins de novo nod for bone marrow analysis software

Dive Brief:

Scopio Labs has received de novo authorization for a device that finds and presents images of cells in bone marrow smears.
The Food and Drug Administration authorization clears Scopio to add capabilities to its X100 and X100HT devices, imaging platforms that allow users to view blood samples digitally rather than under a microscope. Scopio announced the de novo clearance on Wednesday.
Siemens Healthineers struck a deal to distribute Scopio’s platforms in 2023. The company identified the technology as a way to make laboratory workflows more efficient.

Dive Insight:
Scopio launched in 2015 with the goal of “developing the next generation of microscopes.” The company has passed a series of milestones over the past four years, receiving CE marks and FDA clearances, raising $66 million across series B and series C financing rounds, and striking deals with Beckman Coulter and Siemens. 
The FDA granted 510(k) clearance to Scopio’s X100 device in 2020 and cleared its high-throughput sibling, X100HT, via the same pathway in 2022. The clearances covered the use of the devices for locating and displaying images of white cells, red cells and platelets acquired from fixed and stained peripheral blood smears. 
The de novo authorization covers the application of X100 and X100HT to bone marrow aspirate. In that use, the devices automatically locate and present images of hematopoietic cells on a bone marrow aspirate smear obtained from patients being evaluated for blood diseases. Presenting the images could help trained operators identify and classify each cell according to type. 
Scopio cited Medica’s Easycell Cell Locator as the predicate device when it sought 510(k) clearance for X100, but the bone marrow application breaks new ground, forcing the company to use the de novo pathway. Scopio’s bone marrow application combines high-resolution images with its AI-powered decision support software.
CEO Itai Hayut said in a statement that the technology can help labs to “streamline workflows, reduce operational costs and enhance patient care.” The company added that the software allows specialists to access and review smears remotely and helps facilitate second opinions.
The FDA created special controls as part of the authorization, such as performance data documentation and labeling requirements, enabling other companies to bring similar devices to market via the 510(k) pathway. The controls are intended to mitigate the risks of false positive and false negative results.

Avation Medical adds Vice President of Market Access

Avation Medical, an innovative neuromodulation and digital health company on a mission to make non-invasive peripheral neuromodulation accessible to patients across a variety of clinical conditions, has named Michael Hoffman, a veteran of bringing innovative medical technologies to market, as vice president of market access and payer relations for its newly launched Vivally System. Hoffman will play a pivotal role in formulating, executing, and optimizing market access strategies and reimbursement for Vivally, and establishing and expanding coverage with commercial and government payers, and employer groups in the U.Avation Medical, an innovative neuromodulation and digital health company on a mission to make non-invasive peripheral neuromodulation accessible to patients across a variety of clinical conditions, has named Michael Hoffman, a veteran of bringing innovative medical technologies to market, as vice president of market access and payer relations for its newly launched Vivally System. Vivally is the first FDA-cleared, non-invasive closed-loop neuromodulation system to treat symptoms of overactive bladder (OAB) in adults. Hoffman will play a pivotal role in formulating, executing, and optimizing market access strategies and reimbursement for Vivally, and establishing and expanding coverage with commercial and government payers, and employer groups in the U.S.“Adding Michael to the Avation leadership team is our next step in launching Vivally,” said Jill Schiaparelli, founder and CEO of Avation Medical. “Patients have been crystal clear that they want a surgical-free, non-invasive treatment option for their OAB symptoms. Our focus now is to ensure that Vivally is easily accessible to the 46 million patients suffering from OAB in this country.”
Hoffman has more than two decades of experience in the healthcare industry and, specifically, helping to gain and expand access and coverage for innovative products including for medical treatment for multiple sclerosis at Octave Bio and for novel autoimmune diagnostics from ExaGen.
“I’m excited to work with Vivally because it is the only closed-loop non-invasive wearable neuromodulation system for OAB and eliminates the need for surgery and drugs,” said Hoffman. “The market is always looking for first-of-its-kind innovation that meets an unmet need of a large market. I look forward to working with my payer contacts on expanding coverage and access for Vivally.”
Schiaparelli adds that the OAB patient population is unhappy with current options, noting that while OAB is a chronic condition, nearly 90 percent of patients drop out of the care pathway after just two years of any treatment. “Before Vivally, patients had to choose between drugs and their side effects or the risks, and the scars of surgery; the choices are so unappealing that most patients would rather live with OAB, a chronic condition that requires the use of diapers and catheters,” said Schiaparelli. “We’re already seeing great interest from clinicians, and patients and look forward to Michael helping to pave the way toward market access for our treatment option.”
Using proprietary algorithms and electromyographical sensors, Vivally detects and automatically calibrates the level of energy being delivered to a patient’s tibial nerve during stimulation to ensure optimal, customized therapeutic output in a true real-time, closed-loop system. Worn on the ankle, Vivally is used by patients at home for therapy sessions lasting only 30 minutes, as little as once per week. Unlike other approaches for bladder treatment, Vivally requires no surgery, drugs, or needles, which is a major advancement in the treatment of urinary urge incontinence and OAB.
In two multi-center clinical trials, the Vivally System was shown to significantly reduce daily void, incontinence, and urgency episodes and improve patient quality of life while facilitating an 89-percent therapy compliance rate. Symptom reduction was demonstrated out to one year, even with a decrease in therapy frequency. Vivally was recently featured on the cover of Urology®, the Gold Journal.
The Vivally System is a convenient, next-generation, at-home wearable neuromodulation therapy that is discreet, comfortable, and easy to use. Urology teams collaborate with their patients through online diaries and individualized data to validate, treat, and monitor symptoms for optimal success. Clinicians can increase the number of patients they are able to effectively treat while reducing the cost of care, thus positively impacting both patients and the healthcare system.

Bruker to acquire Nanostring for $393M

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Dive Brief:

Scientific instruments maker Bruker will pay about $392.6 million in cash to acquire most of the assets of Nanostring, a provider of research tools for spatial biology and gene expression, Nanostring said Wednesday.
The sale will conclude Nanostring’s bankruptcy proceeding and restructuring process, the Seattle-based company said. When it filed for Chapter 11 protection in February, Nanostring disclosed it had received multiple early indications of interest from possible acquirers. 
Bruker’s acquisition, which includes the assumption of certain liabilities, will allow Nanostring’s business operations and product development initiatives to continue for customers and substantially all of the company’s employees, Nanostring said.

Dive Insight:
At the time of its bankruptcy filing, Nanostring said a large jury award last year in a patent infringement lawsuit by rival 10x Genomics forced the company to take action to protect its business.
In acquiring Nanostring, Bruker will strengthen its position in the emerging field of spatial technology for disease diagnosis and treatment, according to Leerink Partners, which estimates the sector ultimately could become a $12 billion market.
Billerica, Massachusetts-based Bruker is acquiring Nanostring at a roughly 80% premium to a $220 million stalking horse bid received in March from Patient Square Capital, Leerink analyst Puneet Souda said in a research note. The liabilities to be assumed are likely some portion of the damages awarded to 10x Genomics in the patent case, the analyst said.
Souda wrote that the acquisition is a “positive for the company’s post genomics era outlook longer-term.”
TD Cowen analyst Dan Brennan noted Nanostring has several patent cases ongoing in the European Union and U.S. involving 10x Genomics that were paused after the bankruptcy filing, and the timeline for the litigation to be resolved is unclear.
“We expect [Bruker] would not conduct this M&A unless they felt they had a strong IP position,” Brennan wrote in a research report.
The acquisition, which was agreed upon under the court-supervised sale process, is expected to close in early May, according to Nanostring. Bruker submitted a qualifying bid on April 12, and a revised offer from the company was selected as the winning bid following an auction on April 16. The agreement remains subject to bankruptcy court approval and other customary closing conditions.
“Our loyal customers, suppliers and employees have stood with us through this dynamic period, and we are grateful for their dedication to the future of our technology and our mission to map the universe of biology,” Nanostring CEO Brad Gray said in a statement.