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Software as a Medical Device

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Software-based medical devices go through a series of defined processes and regulatory requirements.

Development and Lifecycle Management of Software as a Medical Device

The FDA has granted Premarket Approval (PMA) to Endotronix’s Cordella Pulmonary Artery (PA) Sensor System for use in patients with New York Heart Failure (NYHA) class III heart failure. According to the company, the approval marks the first PA pressure-guided platform for home-based comprehensive heart failure management. Additionally, the device operates by providing daily PA pressure readings from an implanted sensor along with non-invasive vitals such as blood pressure, heart rate, and weight.

"This approval is very exciting and has the potential to transform care for HF patients. Endotronix's solution provides a more complete clinical picture of the patient, so providers are able to make informed remote care decisions between office visits," national trial principal investigator Liviu Klein, MD, MS, section chief, advanced heart failure, mechanical circulatory support, pulmonary hypertension, and heart transplant, University of California San Francisco, said in a press release. "PROACTIVE-HF demonstrated that with Cordella clinicians achieved more optimal and timely dosing of key HF medications, significantly improving outcomes. In addition, the easy-to-use platform engages patients to drive consistent daily habits and self-awareness of trends to support sustainable lifestyle changes."

Approval of the sensor system was based on data from the multi-center, prospective PROACTIVE-HF trial, which implanted 528 NYHA class III HF patients across 75 sites in the United States and Europe. The trial met its primary safety and efficacy endpoints as well as multiple secondary endpoints.

Results found that after implantation, a significantly low rate of hospitalization at 0.159 due to heart failure and all-cause mortality at the six-month mark. Further, results found a 23-meter improvement in a six-minute walk test, improvement in NYHA designation for 144 patients, an average decrease of 2.2 lbs in at-home weight, a 5.9 mmHg decrease for in-office systolic blood pressure from baseline, and a 2.4 mmHg decrease in seated mean PA pressure from baseline for congested patients.

"These results are the culmination of many years of hard work and dedication by the Endotronix team and our clinical partners as we strive to provide best-in-class care for heart failure patients," said Harry Rowland, CEO, co-founder of Endotronix, in a press release. "We believe proactive, comprehensive care with Cordella improves the lives of patients living with heart failure and PROACTIVE-HF provides compelling evidence to support this new approach to impactful remote care delivery. With commercial launch expected later this year, we look forward to supporting clinicians in helping heart failure patients lead more full and active lives."

According to Endotronix, Cordella also permits seated PA pressure measurements with a handheld reader, patient visibility into key health trends to support healthy lifestyle changes, secure tablet messaging between clinical teams, patients, and caregivers, and implantation reimbursement.

Cordella is expected to launch in the United States later this year, while also submitting for CE Mark review in Europe. A decision on European market access is expected next year.

"At Endotronix, we firmly believe that innovation can drive patient care excellence in the home and ultimately change outcomes for patients with heart failure, one of the largest cost categories in healthcare. The FDA's approval validates this foundational belief and is a major milestone for our company and the field of HF management," said Rowland, in the press release. "With this approval, we will deliver proactive, comprehensive care that extends optimal HF therapeutic management to more patients, keeping them out of the hospital and living more fulfilling lives."

1. Endotronix Receives FDA Premarket Approval of the Cordella™ PA Sensor System for the Treatment of Heart Failure. 

 June 24, 2024. Accessed June 25, 2024. https://www.prnewswire.com/news-releases/endotronix-receives-fda-premarket-approval-of-the-cordella-pa-sensor-system-for-the-treatment-of-heart-failure-302179602.html

2. Endotronix Presents Positive PROACTIVE-HF Clinical Trial Results for its Cordella Pulmonary Artery Sensor. 

 March 5, 2024. Accessed June 25, 2024. https://www.prnewswire.com/news-releases/endotronix-presents-positive-proactive-hf-clinical-trial-results-for-its-cordella-pulmonary-artery-sensor-302080673.html

Cordella is the first pulmonary artery pressure-guided platform indicated for home-based comprehensive heart failure patient management.



FDA Grants Premarket Approval to Endotronix’s Cordella Pulmonary Artery Sensor System to Support Patients with Heart Failure

Over the course of 25 years, Amy West, the head of US digital transformation & innovation at Novo Nordisk, has established herself as a seasoned marketing strategist and a distinguished leader in the commercial healthcare sector. Her unwavering dedication to improving patient experiences and outcomes through cutting-edge technologies and innovations has made her a driving force in the industry.

As the visionary behind Novo Nordisk's innovation incubator, Apis Labs, West has played a pivotal role in shaping customer experience and digital innovation strategies, keeping pace with the ever-evolving healthcare landscape. She shares her insights on fostering collaboration, embracing change, and her compelling vision to revolutionize digital transformation and innovation in the field of healthcare.

: What are some of the current disparities for access to healthcare and therapies? What can help bridge the gap?

 Health equity should be a fundamental principle—full stop. If we can all agree on anything, it should be ensuring that everyone has a fair and just opportunity to be as healthy as possible.

But the reality is, of course, messier. Disparities in access to healthcare and therapies persist, stemming from various factors that shape our health beyond our genes and lifestyle choices, like social determinants of health (SDoH) and systemic challenges. Here’s an example: Rock Health’s 2020 Consumer Adoption Report1 found that during the COVID-19 pandemic, 53% of LGBTQ+ respondents delayed or avoided medical care compared to 41% of non-LGBTQ+-identifying respondents. The study also found that despite the recent expansion of telehealth adoption, distance still limits access to care for many Native American and rural patients. In short, too many communities continue to struggle to access quality healthcare.

We can do better. To bridge the gap, we need to explore innovative approaches that meet individuals where they are based on their needs and preferences. Technology can play a pivotal role by empowering individuals with better access and control over their health. Creating Specific, Measurable, Achievable, Relevant, and Time-bound (SMART) environments that leverage technology to bring healthcare directly to those with limited access or flexibility can be transformative. We are starting to see it in action, not surprisingly from young innovators and startups. Companies like Health in Her HUE2 are connecting black women and women of color to culturally sensitive healthcare providers, evidence-based health content, and community support, which is a step towards reducing disparities. It’s only the beginning of what’s possible, and it’s exciting to see where we will go next and how quickly we will get there.

: What impact does health inequity have on specific populations?

 Health inequity, closely linked with social or economic disadvantage, significantly affects specific populations in the United States. This includes socioeconomically disadvantaged populations and underserved rural populations. According to the CDC, the decline in overall life expectancy in the United States in 2020 as a result of COVID-19 was significantly more pronounced for Black and Hispanic individuals.

COVID-19 has intensified these disparities, leading to disproportionate impacts on vulnerable groups. For instance, individuals who were uninsured for a year or longer were more likely to be young, Latinx/Hispanic, poor, sicker, and living in the South, as reported by the Commonwealth Fund. It's essential to recognize that race and age play significant roles in health disparities. For instance, Hispanics have a higher rate of being uninsured, and immigrant communities and wage workers may struggle to access affordable coverage, pushing them towards using emergency rooms as their primary care and hindering preventive care utilization.

The numbers paint a clear picture that can’t be denied: poverty is strongly correlated with poorer health outcomes and an increased risk of premature death. The lack of access to healthcare, education, and healthy behaviors perpetuates disparities that can endure across generations.

: How can technology empower individuals to overcome access challenges in healthcare?

 Technology holds immense potential in empowering individuals to overcome access challenges in healthcare. By providing flexible, user-friendly digital health solutions, we can bridge geographical, financial, and technological barriers. Telemedicine, remote patient monitoring, and virtual care platforms bring healthcare directly to people's homes, reducing the burden of travel and expenses associated with clinic visits.

Additionally, digital health apps, wearable devices, and the Internet enable individuals to take charge of their health by tracking vital signs, monitoring chronic conditions, and accessing evidence-based health information. SMART environments, driven by technology, can deliver personalized care and interventions catering to individual needs and preferences. By putting the focus of control in the hands of patients, we empower them to actively manage their health and well-being in more efficient and cost-effective ways, regardless of their access challenges. It’s important to note, though, from an equity standpoint, there are still many who do not have access to digital technologies. This will change over time, but the disparity still exists today.

: How does health inequity impact the efforts of pharmaceutical companies to improve patient outcomes?

 Health inequity poses significant challenges to pharmaceutical companies striving to improve patient outcomes. Addressing disparities requires a comprehensive approach that considers the diverse needs of underserved populations. Access barriers can impede patients from accessing and adhering to essential medications, which, in turn, hampers treatment efficacy and health outcomes.

Pharmaceutical companies must be cognizant of these challenges and work collaboratively to implement targeted interventions that understand the individual human needs of a diverse population leading multifaceted lives. From my perspective, these efforts should include prioritizing incorporating social determinants of health attributes and data in combination with clinical data, enhancing patient education, collaborating with healthcare providers in underserved communities, and developing pricing and access programs that support patients with financial constraints. By actively addressing health inequity, pharmaceutical companies can contribute to closing the gap in patient outcomes and fostering a more equitable healthcare system.

: How can the healthcare industry and policymakers collaborate to promote health equity and reduce disparities?

 In simplest terms, promoting health equity and reducing disparities requires a united effort between the healthcare industry and policymakers.

Everyone has a role to play. For example, legislators and policymakers play a crucial role in shaping the legislative and regulatory landscape to better support patients and to allow the industry to better support patients, while the healthcare industry can drive change through innovative strategies and interventions.

Collaboration efforts can focus on increasing funding for research and initiatives that address health disparities, improving access to care for vulnerable populations, and fostering diversity and cultural competence within the healthcare workforce. In 2023, this should be table stakes; by now, policymakers should make it a point to work with industry stakeholders to develop policies that incentivize investments in underserved communities and innovative solutions that target specific health disparities.

Additionally, public-private partnerships can foster cross-sector collaboration, combining the expertise and resources of both industry and policymakers to create sustainable solutions. By working hand in hand, the healthcare industry and policymakers can make significant strides towards achieving health equity and ensuring that all individuals have access to quality care and therapies, fostering a healthier and more equitable society.

Health equity remains a paramount goal—and collaborative efforts from industry and policymakers are vital in overcoming disparities and ensuring that every individual has equitable access to quality healthcare and therapies, fostering a healthier and more equitable society.

DeSilva, J.; Prensky-Pomeranz, R.; Zweig, M. Digital Health Consumer Adoption Report 2020. Rock Health. February 26, 2021. https://rockhealth.com/insights/digital-health-consumer-adoption-report-2020/

Find a Provider. Health in Her HUE. https://healthinherhue.com

Amy West, Head of US Digital Health & Innovation Strategy at Novo Nordisk, shares her insights on fostering collaboration, embracing change, and her compelling vision to revolutionize digital transformation and innovation in the field of healthcare.

Q&A with Amy West, Head of US Digital Health & Innovation Strategy at Novo Nordisk

Doctors at the Cleveland Clinic performed the first commercial use of the MARS Surgical System.

Levita Magnetics, makers of the system, announced the usage in a press release. FDA cleared the system in September, 2023.

In a press release, Levita Magnetics CEO Dr. Alberto Rodriguez-Navarro said, “We're thrilled to have initiated successful commercial procedures utilizing the MARS system so soon after receiving FDA clearance. We are at the leading edge of a significant shift in the approach to high-volume minimally-invasive abdominal surgery in the United States and in the world.”

Rodriguez-Navarro said, "We aim to show that this revolutionary technology can empower surgeons with increased control and better visualization while reducing the number of incisions, delivering significant patient benefits. The MARS system can play a major role in the transition of high-volume abdominal procedures to an ambulatory or same day discharge setting."

The MARS surgical system uses magnetic technology to reduce incisions and provide less invasive surgeries.

(October 24, 2023); Levita Magnetics; Levita Magnetics Announces World's First Commercial Use of MARS Surgical System; https://www.prnewswire.com/news-releases/levita-magnetics-announces-worlds-first-commercial-use-of-mars-surgical-system-301965248.html

The system was used by doctors at the Cleveland Clinic.

Levita Magnetics Announces First Commercial Use of MARS Surgical System 

GE Healthcare and Novo Nordisk revealed plans collaborate on advancing the clinical and product development of peripheral focused ultrasound (PFUS). According to a GE press release, the technology has the potential to specifically regulate metabolic function in the body using ultrasound that may support the treatment of chronic diseases such as type 2 diabetes and obesity.

“In an era where diabetes is increasing around the globe, we are enthusiastic about the potential for ultrasound to help people live healthier lives,” said Roland Rott, President, CEO, ultrasound, GE HealthCare. “This collaboration with Novo Nordisk opens a path to evolve ultrasound from a means of screening and diagnosis into therapy, as well. We are eager to validate and further develop this potentially groundbreaking science, as we strive to offer patients alternative treatment options for chronic diseases.”

: GE HealthCare and Novo Nordisk to Collaborate to Advance Novel Non-invasive Treatment for Type 2 Diabetes and Obesity with Ultrasound. 

 October 19, 2023. Accessed October 20, 2023. https://www.gehealthcare.com/about/newsroom/press-releases/ge-healthcare-and-novo-nordisk-to-collaborate-to-advance-novel-non-invasive-treatment-for-type-2-diabetes-and-obesity-with-ultrasound

Joint venture combines GE’s background in ultrasound technology with Novo Nordisk’s experience with metabolic diseases.

GE Healthcare, Novo Nordisk Partner to Advance Novel Non-Invasive Treatment for Type 2 Diabetes and Obesity

XtalPi Inc. announced the launch of a new brand called XtalPi Intelligent Automation. The brand will focus on the development of laboratory automation platforms and will include both hardware and software solutions.

"Our unwavering dedication is to create a robust, intelligent R&D infrastructure, curate tools tailored for optimal data flow, and lead the charge in next-generation automated lab systems," Jian Ma, CEO of XtalPi, said in a press release. "Our infrastructure is meticulously designed to leverage the immense potential of big data. These data are analyzed by AI to provide insights and ideas that guide and accelerate R&D processes. Our diverse portfolio, ranging from individual automated workstations to expansive cluster automation and specialized chemical synthesis services for drug discovery, stands as a testament to our commitment to transforming how science is conducted in the future."

The company made the announcement at the inaugural Intelligent Automation Forum in Shaghai, China.

A new facility will also be built in Shanghai. It is scheduled to go live during the third quarter of 2023 and its initial work will be focused on drug discovery and other pharmaceutical projects.

The company also announced a new automation facility to be located in Shanghai.

XtalPi Inc. Announces New Intelligent Automation Brand

	In a previous interview on digital health, Dr. Michelle Longmire, CEO of Medable, 

discussed advancements in clinical trials

. In this interview we want to add the perspective of a clinical investigator and digital health expert, Dr. David Lee Scher, founder of DLS Healthcare Consulting, and cardiologist at The Heart Group of Lancaster/Penn Med on how digital health is changing in both healthcare and clinical trial settings.

Moe Alsumidaie: How are wearables and digital devices morphing? 



 Digital health started out as a cottage industry and is now dominated by big corporations; for example, but initially, there were only small companies in the industry but now Apple is now leading the way in wearables. Additionally, I observe that digital health tech is becoming ubiquitous and the awareness factor has been surmounted, as evidenced by many of my older patients wearing fitness tracking devices; I don’t have to explain to patients what these technologies are. However, there are some failed outcomes in the evolution of digital health, which introduce negative perceptions that can detract researchers from using digital health in clinical trial settings. For instance, a big clinical study concluded that an increase in the number of steps via Fitbit measurements did not translate to weight loss. Nonetheless, the study did not evaluate other factors that may contribute towards weight loss, such as smoking and sedentarism.

MA: How are wearables being incorporated in healthcare settings?  How about clinical trial settings? 

 I am observing that there aren't a lot of new wearable devices, but, rather the expansion of the use of wearables in healthcare; from a professional standpoint, my practice has moved into wearables, as I am using water-repellant wearables to monitor patients’ heart rhythms for a week instead of having the patient wear a traditional heart monitoring device with patches connected to a monitor for 24-48 hours. I don’t believe there has been much penetration in clinical studies since wearables add a layer of complexity to the study. Additionally, the rudimentary data obtained by these wearables might not be relevant to most clinical trials; for example, vital signs like heart rate or rhythm might not always relate to drug studies. There are some Pharma companies like Pfizer and Sanofi which have embraced digital technologies into their clinical trial strategies.

MA: What functionality would make wearables more applicable towards clinical trials?

 Devices that would collect more information would be very useful in the future, for example wearables that can sample electrolytes, degrees of hydration, and temperature through skin sensors. Wearables providing multiple data points simultaneously, and hence, broader dimensions of data collection. In my opinion, the lack of appreciation of the value proposition of multidimensional wearables is the reason these wearables have not hit the clinical healthcare and clinical trial industries and have remained in the consumer realm. Moreover, many wearables do not structure data in a way that is required for clinical study analysis (i.e., CDISC standards). Although there is some clarity and guidances offered by FDA regarding wearable validation (i.e., 

), there is no specific guidance regarding digital health implementation and data collection in clinical trials. Another point is the lack of analytics tied to the deluge of provided data. In addition, more data is many times not desired by pharma because it leads to more scrutiny by the FDA.

MA: What will studies look like 10-15 years from today?

I would hope that patient-derived data would be an integral part of clinical trials, and hope that the analytics would be there to support study outcomes. The use of digital health would make clinical trials safer, quicker, with better quality data, and faster data collection. If you had adverse events that get to the data safety monitoring board, you could stop the trial much faster than when patients would come in for the visit or report adverse events through traditional methods. You could potentially reduce patient harm and enhance the well-being and rights of subjects. The utilization of blockchain technology, which has nothing to do with wearables but that could take the wearable data and make it traceable, verifiable and safer from a security and privacy standpoint, might find utility for sponsors, clinicians, and patients. This can also be shared and accessed in ways that it can't today and would be a phenomenal jump in the quality of clinical study data and processes. Another addition could be the use of digital biomarkers. Biomarkers don't necessarily translate to traditional vital signs or monitoring data points but are very personal and can also be used for clinical relevance. For example, 

 is a technology company which creates a neurological biomarker based on the way one interacts with a touch screen on a smart phone, tablet, or a computer keyboard. Technologies that leverage data, which can be collected and used in a totally unobtrusive and passive way with the individual, are going to be part of the future of clinical trials. They touch our daily activities without the need of either manual data entry or site visits. It goes without saying that CROs are going to have to find new revenue models because a lot of the work will be overtaken or substituted with such technologies, resulting in a marked decrease in the cost of clinical trials.

 is Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member for and regular contributor to 

In this interview, Dr. David Lee Scher adds his perspective on how digital health is changing in both healthcare and clinical trial settings.

Yervant Chijian

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