Innovative collaboration between Sheba Beyond virtual hospital and Nuvo extends remote monitoring for high-risk pregnant patients to the home

TEL AVIV, ISRAEL, December 11, 2023 /EINPresswire.com/ -- In a groundbreaking healthcare initiative, Sheba Beyond, one of world’s first virtual hospitals, and Nuvo Group, a pioneer in remote pregnancy monitoring solutions, have accelerated their partnership to transform the care of high-risk pregnant patients in times of crisis and beyond. Amidst the challenges posed by the recent war in Israel on October 7th, this advancement in the partnership marks a significant breakthrough in prenatal care, particularly for patients requiring inpatient maternal and fetal monitoring.

Sheba Beyond has been utilizing remote monitoring technologies from Nuvo and other remote care solutions for over a year to monitor pregnant patients that would otherwise have to go back and forth to outpatient clinics, more conveniently. As Israel entered wartime, it became imperative to use creative solutions for even more aggressive remote care models, including de-hospitalizing high risk inpatients. Given Sheba’s existing experience with INVU, it called upon Nuvo to donate additional technologies to support its urgent need to reallocate critical resources to treat civilians and the wounded, while still providing exceptional care to pregnant patients.

The collaboration between Sheba Beyond and Nuvo Group highlights a new era in healthcare resilience, demonstrating the impact of remote pregnancy monitoring even in the most difficult circumstances. If these benefits can be achieved in times of war, it stands to reason the benefits will carry forward in times of peace.

The benefits of remote pregnancy monitoring Sheba Beyond have seen include:
• Clinical Accuracy delivered remotely: Real-time data collection allows for precise monitoring of fetal and maternal health indicators, gathered whilst the patient is comfortably at home, instead of admitted to the hospital for days or weeks on end..
• Resource Optimization: This technology has been instrumental in opening up hospital rooms and reallocating clinical staff to address critical needs during the war.
• Increased Efficiency: Remote monitoring allows for effective patient management with fewer resources, enhancing staff productivity and patient care quality.
• Potentially Improved Patient Outcomes: The comfort of home care reduces maternal stress levels, which may be directly linked to better pregnancy outcomes, including increased gestational age which is directly correlated with reduced NICU admissions. More data will be required to confirm whether there is a directly causal link.

Patients and clinicians have reported positive experiences with the Sheba Beyond remote hospitalization program. Patients have attributed remarkable improvements in their health outcomes to the program, including one patient who said: “I am confident that there is a direct connection between my being hospitalized on a hybrid basis, performing all the necessary pregnancy monitoring tests remotely through your monitoring belt, and the fact that my test results improved. I managed to maintain the pregnancy from week 32 to week 37 when the doctors were certain that I would need to be induced at week 34. Continue with your amazing work, and I believe that this service should be provided in every hospital in Israel and around the world.”

The program’s user-friendliness, even for those not technologically inclined, and its efficiency compared to traditional hospital-based monitoring systems have been particularly praised. Medical professionals have commended the system for its accurate and reliable data, along with the outstanding technical support provided by Nuvo, which has significantly improved the quality of prenatal care.

“Over the past year, we've harnessed state-of-the-art technologies to transform the maternity journey. In these difficult wartime conditions, the need for agility is paramount. Our partnership with Nuvo has been instrumental in swiftly establishing a home hospitalization system for our high-risk pregnancy patients. We designed the intense remote care protocol to deliver top-notch medical attention to our patients in the comfort and safety of their homes. Moreover, being together with their family and kids is especially crucial during times of alarms and the need to remain sheltered. We're excited about the prospect of further expanding this protocol, not just in times of conflict but also, hopefully soon, in periods of peace.,” said Dr, Avi Tsur, MD Director of OBGYN at Sheba Beyond and director of the Sheba Women’s Health Innovation Center.

This innovative approach by Sheba Beyond and Nuvo Group is not only redefining prenatal care in crisis situations but is also setting a new standard for high-risk pregnancy management globally.

“Nuvo is honored to be a part of such an innovative program under incredibly difficult circumstances,” said Kelly Londy, Nuvo CEO. “Nuvo strives to give life a better beginning every day, and the amazing work done by the teams at Sheba Beyond, ARC and Nuvo is truly inspiring. We look forward to continuing our work with Sheba through this crisis and beyond.”

About Sheba Medical Center
The largest and most comprehensive medical center in the Middle East, Sheba Medical Center, Tel Hashomer is generating global impact through its medical care, research and healthcare transformation. Sheba's City of Health boasts an acute-care hospital, rehabilitation hospital, research and innovation hubs, medical simulation center, as well as a center for disaster response on one comprehensive campus in the heart of Israel. Sheba BEYOND is the medical center's innovative virtual hospital, which offers a myriad of technological solutions for advanced patient care. For more information, visit: eng.sheba.co.il

About Nuvo
Nuvo is committed to reinventing pregnancy care for the 21st century through new technology, tools, and practices for providers and expectant mothers, including the INVU by Nuvo™ platform, an FDA-cleared, prescription initiated remote pregnancy monitoring and management system. The INVU™ sensor band enables the delivery of remote non-stress tests and maternal & fetal heart rate monitoring today while pioneering new data-driven personalized pathways that Nuvo believes will help improve health outcomes for all women in the future. The technology and patent estate that underpin the INVU platform have been awarded a variety of industry recognitions, including Fast Company's Next Big Things in Tech (2021), CB Insights' Digital Health 150 (2020, 2022), and MedTech Innovator's Top 50 MedTech Startups (2021), as well as multiple grants from some of the world's leading academic medical centers and scientific bodies.

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Full press release available here.

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This letter to the AJOG editors was originally published November 7, 2023 here.

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To the Editors:

Upon reading the recent American Journal of Obstetrics & Gynecology publication—“Utilization of a wireless monitoring device to perform nonstress tests in high-risk pregnancies from home” by Hamm et al¹ from the University of Pennsylvania—I was struck by the alignment of their findings with our experience at Banner Health.

Banner Health is continuously committed to ensuring that every patient we serve in rural areas is provided with the same safe, high-quality perinatal care we administer to patients in more resourced urban, metro, or academic centers. Our telemedicine obstetrical programs are designed to address the limited access to obstetrics care in these rural areas. Many telehealth solutions in obstetrics do not address fetal monitoring. However, this emerging technology solves that problem.

In our endeavor to provide exceptional care and service to high-risk pregnancies, we integrated the INVU platform, monitoring patients during the past year. As we engaged in multiple sessions, a pattern of reliability and efficiency emerged, successfully obtaining an interpretable nonstress test (NST) in most appointments.

The use of the INVU platform was accompanied by a discernible improvement in visit compliance rates. Patients using INVU did not miss appointments because barriers to access to care were eliminated. Mirroring the study’s feedback, most of our patients have expressed a preference for the convenience and reassurance of remote NSTs.

The article’s conclusion, emphasizing INVU’s potential to address healthcare inequities and enhance perinatal outcomes, resonates deeply with Banner’s mission—“Making healthcare easier, so life can be better.” As a community of clinicians, recognizing and embracing these transformative innovations will be instrumental in shaping the future of maternal healthcare.

Thank you Hamm et al and AJOG for your unwavering dedication to pushing the boundaries of obstetrics and gynecology towards ongoing improvement. With platforms, such as INVU, I believe that we are on the cusp of a new era in maternal care, marked by safety, equity, and innovation.

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Former CEO & Chairman of the Management Board at Fresenius Medical Care brings extensive experience in growing new medical solutions into public market leaders

We are delighted to have Rice join the board at a time when Nuvo is poised for significant growth.”— Kelly Londy, CEO of Nuvo Group

TEL AVIV, ISRAEL, August 31, 2023/EINPresswire.com/ -- Nuvo Group Ltd. (“Nuvo”), the creators of INVU by Nuvo™, an FDA-cleared remote pregnancy monitoring platform, announced the appointment of Rice Powell to its Board of Directors.

Mr. Powell is the former Chief Executive Officer and Chairman of the Management Board of Fresenius Medical Care, one of the world’s leading provider of products and services for people with chronic kidney failure. Prior to becoming chief executive officer, he was vice chairman of the management board and member of the management board responsible for the North American region from 2010 through 2012. Powell joined Fresenius Medical Care in 1997 and was appointed to the company's management board and co-chief executive officer of Fresenius Medical Care North America in 2004. Powell has more than 36 years of experience in the healthcare industry. Between 1978 and 1996, he held a number of positions at Baxter International Inc. and Biogen Inc. in the United States.

“We are delighted to have Rice join the board at a time when Nuvo is poised for significant growth,” said Kelly Londy, Nuvo CEO. “Rice’s leadership and proven track record of driving new medical solutions into market leaders will be valuable in our expanded market adoption of Nuvo’s remote pregnancy monitoring capabilities.”

“I’m excited to help Nuvo in its mission to give life a better beginning. Similar to the dialysis market years ago, pregnancy care has seen far too little innovation and presents a huge opportunity to improve people’s lives,” Mr. Powell said. “I look forward to working with Kelly, my fellow directors and the Nuvo team to make Nuvo a leader in this space.”

About Nuvo
Nuvo is committed to reinventing pregnancy care for the 21st century through new technology, tools, and practices for providers and expectant mothers, including the INVU by Nuvo™ platform, an FDA-cleared, prescription initiated remote pregnancy monitoring and management system. The INVU™ sensor band enables the delivery of remote non-stress tests and maternal & fetal heart rate monitoring today while pioneering new data-driven personalized pathways that Nuvo believes will help improve health outcomes for all women in the future. The technology and patent estate that underpin the INVU platform have been awarded a variety of industry recognitions, including Fast Company's Next Big Things in Tech (2021), CB Insights' Digital Health 150 (2020, 2022), and MedTech Innovator's Top 50 MedTech Startups (2021), as well as multiple grants from some of the world's leading academic medical centers and scientific bodies. Nuvo is led by a diverse team of experienced business and medical professionals, dedicated data engineers, software designers and proud parents who embrace a collective mission to give every life a better beginning. For more information and complete indications, contraindications, warnings and precautions along with instructions for use, visit: www.nuvocares.com.

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Full press release available here.

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This research was published in the AJOG, June 9, 2023 here.

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Objective

The need for serial in-office nonstress tests (NSTs) adds substantial burden to high-risk pregnancies and exacerbates care disparities.INVU by Nuvo Group, Ltd, is a novel Food and Drug Administration-cleared, remote, self-administered maternal-fetal monitoring solution, previously validated for fetal and maternal heart rates and uterine activity measurements. Here, we sought to determine the clinical interpretability and usability of INVU to enable patients to perform NSTs from home.

Study Design

This was a prospective, open-label, single-site study of a wireless, remote pregnancy monitoring system (INVU by Nuvo Group, Ltd) in high-risk pregnancies to remotely perform clinically indicated NSTs instead of in-clinic NSTs. This study was approved by the University of Pennsylvania Institutional Review Board, and participants provided informed consent.

The INVU belt contains 8 biopotential and 4 acoustic sensors, which passively record abdominal signals (Figure, A). The monitoring system includes a Health Insurance Portability and Accountability Act–compliant mobile application that allows clinicians to view and interpret the NST and communicate with the patient in real time (Figure, B).

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We enrolled singleton pregnancies at ≥32 weeks of gestation with clinical indications for antenatal fetal surveillance, pregravid body mass indices (BMIs) of ≤50 and ≥15 kg/m², and Wi-Fi access. Exclusions were uncontrolled hypertension, major fetal anomaly, abdominal skin issues, or an implanted electronic device.

The primary outcome was whether the remote NST was deemed acceptable for clinical utility (interpretability). For the secondary outcomes, we evaluated reactivity rates among NSTs deemed clinically acceptable (reactivity) and the frequency and reason for recommending an in-clinic evaluation. Moreover, participants completed the validated System Usability Scale (SUS).

Descriptive analyses were performed using SAS (version 9.4; SAS Institute, Cary, NC).

Results

We enrolled 34 high-risk patients at a mean gestational age of 34.5±1.1 weeks and a BMI of 35.8±6.3 kg/m² from December 10, 2020, to March 6, 2022. Fetal testing indications included advanced maternal age (n=14), BMI of ≥40 kg/m² (n=11), gestational diabetes mellitus (n=10), chronic hypertension (n=3), antiphospholipid syndrome (n=2), and other (n=9).

Of note, 5 consented patients failed to complete device training. The remaining 29 patients had 131 qualifying remote NST sessions. INVU successfully obtained an interpretable NST in 93.9% of appointments (n=123), of which 98.3% (n=121) were deemed reactive. Patients avoided an in-office visit in 88.5% of visits. Only 2 appointments (1.5%) resulted in a recommendation for nonurgent delivery, both for elevated blood pressure and neither related to the NST tracing. Only 1 patient (2.9%) experienced mild, transient soreness at the sensor site without redness or bruising.

Of note, 23 patients (79.3%) who attempted at least 1 remote NST completed the SUS, with a mean score of 76.5 (±15.9) of 100.0, indicating “good” usability, with 22 patients (95.7%) agreeing they would prefer remote NSTs vs in-office testing in a future pregnancy. Further details and discussion are available in the Supplemental Materials and Methods.

Conclusion

In this prospective cohort study, >90% of NSTs performed remotely using INVU were acceptable for clinical utility, and >88% of NST appointments were completed without in-clinic evaluation. In addition, INVU demonstrated an excellent safety profile and good patient usability. Future research is warranted to determine how to best leverage this novel capability to address inequities in patient access and improve perinatal outcomes.

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Combination of clinical telehealth excellence & FDA-cleared remote monitoring platform provides a one-of-a-kind solution for next generation pregnancy care

The innovative offering from Nuvo & Ouma addresses critical gaps in pregnancy care journeys while maintaining the highest levels of medical care, allowing patients access when & where they need it.”— Kelly Londy, CEO of Nuvo Group

TEL AVIV, ISRAEL, December 13, 2022 /EINPresswire.com/ -- Nuvo Group (Nuvo), the creators of INVU by Nuvo™, an FDA-approved remote pregnancy monitoring platform, and Ouma Health (Ouma), a total maternity telehealth services company, today announced a strategic partnership to deliver an innovative joint solution that provides clinical excellence in maternity telehealth and FDA-cleared remote fetal surveillance technology. The joint solution is designed to address some of the biggest challenges in pregnancy care today, by enabling equitable access to care, improving preventative care delivery, and reducing high individual and system-level costs.

The joint solution is a “one-stop shop” for remote pregnancy care that includes:

● Innovative platform for remote patient monitoring (RPM) including FDA-cleared non-stress tests (NST), along with devices for diabetes and hypertension management
● 24/7/365 maternity telehealth clinical services available in all fifty US states, including access to maternal-fetal medicine specialists, midwives, perinatal nurse navigators, lactation consultants, and behavioral health specialists with expertise in perinatal mood disorders

Nuvo and Ouma were both founded with shared principles: building solutions based on clinical evidence, improving clinical outcomes, and increasing patients’ access to care and peace of mind. Nuvo’s FDA-cleared, clinically validated remote monitoring solution and Ouma’s network of telehealth clinicians extend medical-grade monitoring and highly trained maternity care experts to fit into patients’ lives and schedules.

“The innovative joint offering from Nuvo and Ouma addresses critical gaps in the pregnancy care journey while maintaining the highest levels of medical care and allowing patients access when and where they need it,” said Kelly Londy, CEO of Nuvo Group. “We are happy to work with Ouma to give employers, health systems, and payers the ability to impact areas of pregnancy care that need it the most.”

“An effective strategy aimed at improving maternity outcomes needs to include an early recognition system coupled with immediate access to expert care,” said Sina Haeri, MD, MHSA, CEO and co-founder of Ouma. “By combining a market-ready RPM solution with world-class clinical services, we aim to deliver the clinical care in the comfort of the patient’s home, saving the family unnecessary time commuting to appointments, absenteeism from work for routine visits, and most importantly, immediate access to expert care in case of clinical need for timely intervention.”

Self-insured employers, health systems, and payers can all benefit from adopting this new solution for the flexibility, scalability, and convenience it provides their organizations, patients, and members. More than half (54%) of counties in the United States offer very limited or no access to maternity care. Within these counties, more than 2.2 million women of child-bearing age live in full maternity care deserts – areas with no hospital offering obstetric care, no birthing center, or no obstetric provider. Additionally, 1-in-3 patients change insurance providers from preconception to postpartum, though this solution provides an important competitive advantage to improve member satisfaction, retention, and improved outcomes.

If you are interested in learning more about this joint solution, please reach out to info@nuvocares.com or info@oumahealth.com

About Nuvo Group
Nuvo Group Ltd. ("Nuvo") is committed to reinventing pregnancy care for the 21st century through new technology, tools, and practices for providers and expectant mothers, including the INVU by Nuvo™ platform, an FDA-cleared, prescription initiated remote pregnancy monitoring and management system. The INVU™ sensor band enables the delivery of remote non-stress tests and maternal & fetal heart rate monitoring today while pioneering new data-driven personalized pathways that Nuvo believes will help improve health outcomes for all women in the future. The technology and patent estate that underpin the INVU platform have been awarded a variety of industry recognitions, including Fast Company's Next Big Things in Tech (2021), CB Insights' Digital Health 150 (2020, 2022), and MedTech Innovator's Top 50 MedTech Startups (2021), as well as multiple grants from some of the world's leading academic medical centers and scientific bodies. Nuvo is led by a diverse team of experienced business and medical professionals, dedicated data engineers, software designers and proud parents who embrace a collective mission to give every life a better beginning.

For more information and complete indications, contraindications, warnings and precautions along with instructions for use, visit: www.nuvocares.com.

About Ouma Health
Ouma Health is a total maternity telehealth platform with the vision of expanding access to expert care for all pregnant individuals. Ouma leverages telehealth to provide access to expert maternity clinicians including Maternal-Fetal Medicine (MFM) physicians, midwives, perinatal nurse navigators, lactation specialists, and behavioral health specialists with expertise in perinatal mood disorders. Ouma clinicians are US-based, and licensed to practice medicine in all fifty states, and have the ability to diagnose and prescribe. Ouma was founded by a physician and is led by a seasoned team of telehealth operators and serves self-funded employers and state medicaid plans nationally.

For more information, visit: www.oumahealth.com.

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Full press release available here.

Sometimes problems are relative, sometimes they are absolute. In the United States, maternal mortality is both. As of April 2022, the U.S. ranked last among other high income nations for maternal mortality rates. In absolute terms, the U.S. maternal mortality rates trend up, year after year. Most notably, maternal mortality among black women is staggeringly high. In fact, black women are three times more likely to die from pregnancy related causes than their white counterparts in the U.S. These sobering stats are true despite the fact that the U.S. spends more than any other nation on in-hospital maternity care. Despite significant publicity, women continue to die needlessly in their quest to bring new life into the world. This must change.

Sadly, these trends are old news. From 1955 until 1985 maternal mortality in the United States decreased by 99 percent. This enormous public health victory halted after 1985. Since 1985 U.S. maternal mortality rates have trended steeply up. There is no consensus on why the U.S. fares so poorly compared to other developed nations - and even lags behind some underdeveloped countries. However, there is consensus around one thing - it is time to fix these trends and save women’s lives.

Albert Einstein said that if he had an hour to solve a problem he would spend 55 minutes thinking about the problem and five minutes thinking about the solution. There is no question that we are thinking about this problem. High-profile news outlets are publicizing this crisis. This year alone, CNN, ABC, and the Wall Street Journal all published prominent articles about maternal mortality and lack of care in the United States. These articles represent noble efforts to galvanize support to halt and reverse these painful trends. Our federal government has introduced no less than 26 bills to address maternal mortality. State governments have introduced even more than that. Celebrities like Serena Williams, Beyonce, Michelle Obama, and Kamala Harris have all been shouting from the mountaintops about the black maternal mortality crisis. Major entities like Optum, Merck, and the Wilson Center all dedicate enormous resources to publicizing and understanding the maternal mortality problem.

No doubt, publicity, funding, and legislation like this is good. But the harsh reality is that elevating the profile of maternal mortality is only good if it induces action. We are heeding Albert Einstein’s advice - sort of - by spending time and resources on the problem. Einstein’s quote implies, however, that those 55 minutes should be dedicated to really digging into the roots of the problem, why it exists, and how it came to be. That we have not done.

Unless and until we move from awareness to action, we will not reverse these harrowing trends. We owe it to women to value their lives and the lives of their babies enough to find a new way of thinking about maternal mortality.

To solve this problem we need to focus on three things:

• Interest
• Investment
• Innovation
  

Interest

Given the publicity mentioned earlier, calling for more interest may seem counterintuitive. Yet, even with all of the publicity and attention, the U.S. population generally, and the medical/public health community specifically, does not focus on maternal mortality in the United States. Other than Merck, there are no Fortune 500 companies that devote their charitable dollars towards maternal mortality improvements. Sure, giants like Walmart, Target, Medtronic, Genentech, State Farm, Best Buy, and Accenture have teamed up to create the Black Community Innovation Coalition. But maternal/fetal health is only a small subset of this effort. While black maternal mortality is an outsized problem compared to maternal mortality for other demographics, focusing exclusively on the problem for black women does not address the problem for everyone. In short, most of Corporate America is not yet focused on fixing this problem.

There is also a dearth of interest from the public generally. As former Congressman and Obstetrician, Phil Gingrey, points out, “more must be done; more coordination, more dedication, and more dollars.” This issue cannot be solved until Americans across the map recognize the problem and demand change from their representatives, corporations, and doctors.

Investment

Interest is necessary but not sufficient. Maternal health needs investment. In 2016, pregnancy and postpartum care cost private insurers $52.8 billion - making it the third highest cost condition in the United States. However, conditions like diabetes and back/neck pain impact far more people than pregnancy at any given moment in time. Much of that $52.8 billion dollars could be saved with more investment into new innovations and technologies for prenatal care.

Investment trends for FemTech are, admittedly, good. VC funding for FemTech between 2015-2021 went from $600 million to $1.9 billion. Even with this increase, FemTech and maternal care is still sorely underfunded. Just 2% of medtech funding goes towards non-cancer related women’s conditions. The trends are in maternal care’s favor. We have reason to be hopeful. But there is still a large gap between the need in the market and the funding to scale solutions. We urgently need passionate and brave investors to see the massive opportunity that exists to modernize pregnancy care and get in on the ground floor of new maternal health technology that opens access, utilizes telemedicine, and changes standards of care.

Innovation

Finally, we must see innovation in this space. Obstetric ultrasound was created in 1956. In the 1970’s OB ultrasound exploded as the standard of care. But the 1970’s were the beginning and the end of significant technological innovation in maternal care. In the last 50 years, image quality has improved but there has been virtually no significant technological change for maternal care. Doctors still use 40 year old technology to measure and examine pregnant mothers and their fetuses. But there is hope and we are on the cusp of a revolution.

Technologies like Nuvo’s remote maternal-fetal monitoring, PulseNmore’s remote OB ultrasound, and Ouma Health’s telemedicine network will change not just how women are treated, but also who can access excellent care. Until these, and other innovations are created, approved, and adopted at scale, we cannot change the status quo of maternal morbidity and mortality in the U.S. Once real changes in interest, investment, and innovation happen, more mothers will get to see their beautiful babies grow and thrive. The time has come to make this a reality.

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This article was published in collaboration with Andrea Wolf on LinkedIn.

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Early-stage collaboration includes the evaluation of a new virtual care regimen for managing gestational diabetes and the use of AI to develop personalized care pathways and predictive analytics

TEL AVIV, Israel, Aug. 17, 2022 /PRNewswire/ -- Nuvo Group—the creators of INVU by Nuvo™, an FDA-approved remote pregnancy monitoring platform—announced today that it has completed the first phase of its collaboration agreement with Israel's Sheba Medical Center's "Sheba BEYOND", one of the Top Ten medical centers in the world (NEWSWEEK) and a global leader in biotechnological innovation.

The first phase of the partnership consisted of a groundbreaking pilot program around gestational diabetes management, in which medically necessary non-stress tests (NSTs) were shifted to home-based, remote monitoring using INVU™ rather than conducting traditional monitoring in a medical facility. Participating physicians prescribed INVU to expectant mothers, who wore the sensor band from home during virtual visits. During these virtual visits anchored by the hospital's Sheba BEYOND, virtual hospital platform, a live reading allowed the expectant mother to access simplified data and insights via the paired INVU app, while the provider received more detailed fetal and maternal surveillance that OB/GYNs are accustomed to receiving during in-office visits.

To provide a comprehensive virtualized care regimen, the pilot program also included the use of several other telemedicine solutions alongside INVU, including a remote ultrasound device, glucose monitoring, and home urinalysis kit. In addition to offering a safe and proven regimen for managing gestational diabetes, the program aimed to help patients and providers save time and ultimately improve the overall care experience.

For the next phase of the partnership, Nuvo and Sheba intend to work together to integrate the INVU platform into the hospital's standard of care protocols. They also plan to utilize data collected from the pilot program to develop new AI tools with the goals of advancing pregnancy care management, improving outcomes, and lowering costs.

"Our long term goal is to provide pregnant women with the best possible maternal-fetal surveillance wherever they are – in our clinics, at the comfort of their home or during their work day," said Dr. Avi Tsur, high-risk pregnancy expert and director of Sheba's Women's Health Innovation Center and Sheba BEYOND's Obstetrics & Gynecology Beyond tele-health platform. "The INVU fetal monitoring solution has the potential to be a catalyst of transformative care in an area of medicine that has been lagging in innovation and new approaches for decades. I hope this pilot is only the beginning."

Dr. Galia Barkai, Director of Sheba BEYOND added, "Sheba Beyond is constantly adopting cutting-edge technologies, which are enabling patients to receive the best care in the comfort of their homes. This collaboration is yet another step towards our goal to bring high level, hospital care, to everyone, everywhere."  

"It is an honor to collaborate with a leading medical center like Sheba to bring Nuvo's INVU technology to expectant mothers in Israel," said Kelly Londy, CEO of Nuvo Group. "The INVU platform is particularly beneficial for high-risk pregnancies that would otherwise require frequent in-office visits, which we know can become burdensome on all sides. We look forward to the next phase of our partnership as we continue to work with Sheba to help deliver safe and reliable remote care to even more patients."

"Sheba aspires to be the institution that comes to mind when thinking about transformative healthcare," Prof. Eyal Zimlichman, chief transformation officer and chief innovation officer at Sheba Medical Center maintained. "We do this by staying ahead of the curve when it comes to the latest and greatest advancements, as we know that transformation via innovation is the fastest path to material change. We're excited about what this partnership with Nuvo can mean for the future of pregnancy care."

About Nuvo Group

Based in Tel Aviv, Israel, Nuvo Group Ltd. ("Nuvo") is committed to reinventing pregnancy care for the 21st century through new technology, tools, and practices for providers and expectant mothers, including the INVU by Nuvo™ platform, an FDA-cleared, prescription initiated remote pregnancy monitoring and management system. The INVU™ sensor band enables the delivery of remote non-stress tests and maternal & fetal heart rate monitoring today while pioneering new data-driven personalized pathways that Nuvo believes will help improve health outcomes for all women in the future. The technology and patent estate that underpin the INVU platform have been awarded a number of industry recognitions, including Fast Company's Next Big Things in Tech (2021), CB Insights' Digital Health 150 (2020), and MedTech Innovator's Top 50 MedTech Startups (2021), as well as multiple grants from some of the world's leading academic medical centers and scientific bodies. Nuvo is led by a diverse team of experienced business and medical professionals, dedicated data engineers, software designers and proud parents who embrace a collective mission to give every life a better beginning.

For more information and complete indications, contraindications, warnings and precautions along with instructions for use, visit: www.nuvocares.com.

About Sheba Medical Center

The largest and most comprehensive medical center in the Middle East, Sheba Medical Center, Tel Hashomer is generating global impact through its medical care, research and healthcare transformation. Sheba's City of Health boasts an acute-care hospital, rehabilitation hospital, research and innovation hubs, medical simulation center, as well as a center for disaster response on one comprehensive campus in the heart of Israel. Sheba BEYOND is the medical center's innovative virtual hospital, which offers a myriad of technological solutions for advanced patient care. For more information, visit: eng.sheba.co.il

SOURCE Nuvo Group

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This article was originally published in Frontiers in Bioengineering & Biotechnology July 2022 here.

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Background: Uterine activity (UA) monitoring is an essential element of pregnancy management. The gold-standard intrauterine pressure catheter (IUPC) is invasive and requires ruptured membranes, while the standard-of-care, external tocodynamometry (TOCO)’s accuracy is hampered by obesity, maternal movements, and belt positioning. There is an urgent need to develop telehealth tools enabling patients to remotely access care. Here, we describe and demonstrate a novel algorithm enabling remote, non-invasive detection and monitoring of UA by analyzing the modulation of the maternal electrocardiographic and phonocardiographic signals. The algorithm was designed and implemented as part of a wireless, FDA-cleared device designed for remote pregnancy monitoring. Two separate prospective, comparative, open-label, multi-center studies were conducted to test this algorithm.

Methods: In the intrapartum study, 41 laboring women were simultaneously monitored with IUPC and the remote pregnancy monitoring device. Ten patients were also monitored with TOCO. In the antepartum study, 147 pregnant women were simultaneously monitored with TOCO and the remote pregnancy monitoring device.

Results: In the intrapartum study, the remote pregnancy monitoring device and TOCO had sensitivities of 89.8 and 38.5%, respectively, and false discovery rates (FDRs) of 8.6 and 1.9%, respectively. In the antepartum study, a direct comparison of the remote pregnancy monitoring device to TOCO yielded a sensitivity of 94% and FDR of 31.1%. This high FDR is likely related to the low sensitivity of TOCO.

Conclusion: UA monitoring via the new algorithm embedded in the remote pregnancy monitoring device is accurate and reliable and more precise than TOCO standard of care. Together with the previously reported remote fetal heart rate monitoring capabilities, this novel method for UA detection expands the remote pregnancy monitoring device’s capabilities to include surveillance, such as non-stress tests, greatly benefiting women and providers seeking telehealth solutions for pregnancy care.

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This article was originally published in AJOG in 2022 here.

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Background

The serial fetal monitoring recommended for women with high-risk pregnancies places a substantial burden on the patient, often disproportionately affecting underprivileged and rural populations. A telehealth solution that can empower pregnant women to obtain recommended fetal surveillance from the comfort of their own home has the potential to promote health equity and improve outcomes. We have previously validated a novel, wireless pregnancy monitor that can remotely capture fetal and maternal heart rates. However, such a device must also detect uterine contractions if it is to be used to robustly conduct remote nonstress tests.

Objective

This study aimed to describe and validate a novel algorithm that uses biopotential and acoustic signals to noninvasively detect uterine contractions via a wireless pregnancy monitor.

Study Design

A prospective, open-label, 2-center study evaluated simultaneous detection of uterine contractions by the wireless pregnancy monitor and an intrauterine pressure catheter in women carrying singleton pregnancies at ≥32 0/7 weeks’ gestation who were in the first stage of labor (ClinicalTrials.gov Identifier: NCT03889405). The study consisted of a training phase and a validation phase. Simultaneous recordings from each device were passively acquired for 30 to 60 minutes. In a subset of the monitoring sessions in the validation phase, tocodynamometry was also deployed. Three maternal-fetal medicine specialists, blinded to the data source, identified and marked contractions in all modalities. The positive agreement and false-positive rates of both the wireless monitor and tocodynamometry were calculated and compared with that of the intrauterine pressure catheter.

Results

A total of 118 participants were included, 40 in the training phase and 78 in the validation phase (of which 39 of 78 participants were monitored simultaneously by all 3 devices) at a mean gestational age of 38.6 weeks. In the training phase, the positive agreement for the wireless monitor was 88.4% (1440 of 1692 contractions), with a false-positive rate of 15.3% (260/1700). In the validation phase, using the refined and finalized algorithm, the positive agreement for the wireless pregnancy monitor was 84.8% (2722/3210), with a false-positive rate of 24.8% (897/3619). For the subgroup who were monitored only with the wireless monitor and intrauterine pressure catheter, the positive agreement was 89.0% (1191/1338), with a similar false-positive rate of 25.4% (406/1597). For the subgroup monitored by all 3 devices, the positive agreement for the wireless monitor was significantly better than for tocodynamometry (P<.0001), whereas the false-positive rate was significantly higher (P<.0001). Unlike tocodynamometry, whose positive agreement was significantly reduced in the group with obesity compared with the group with normal weight (P=.024), the positive agreement of the wireless monitor did not vary across the body mass index groups.

Conclusion

This novel method to noninvasively monitor uterine activity, via a wireless pregnancy monitoring device designed for self-administration at home, was more accurate than the commonly used tocodynamometry and unaffected by body mass index. Together with the previously reported remote fetal heart rate monitoring capabilities, this added ability to detect uterine contractions has created a complete telehealth solution for remote administration of nonstress tests.

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