This article originally appeared in Fierce Healthcare here.

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Health tech player Philips is joining forces with Nuvo Group to increase access and adherence to prescribed maternity care in rural areas, the companies announced Tuesday.

More than half (54%) of U.S. counties have limited or no access to maternity care and about 35% of those counties are considered maternity care deserts, according to March of Dimes. That leaves more than two million women of reproductive age living in areas with no hospital offering obstetric care, no obstetric provider and no birth center.

In collaborating with Philips, Nuvo will leverage its INVU solution, an FDA-approved remote fetal monitoring platform that facilitates remote non-stress tests and maternal and fetal heart rate monitoring.

The companies will pilot the joint program in rural Colorado as part of an integrated solution for providers. Philips will provide support for the program’s delivery, according to the company.

“Digital solutions and ecosystem-building are critical enablers to addressing disparities in healthcare such as access to maternal healthcare in rural settings,” said Sandra Lesenfants, general manager of hospital patient monitoring at Philips, in a statement. “With this collaboration, we are extending the sight and reach of pregnancy care and bringing more remote monitoring options to the communities and expectant mothers where and when they need them most.”

Nuvo’s remote monitoring solution also has the potential to reduce provider burden by shifting care to the home, the company said, by allowing providers to prescribe the INVU sensor band to expectant mothers to wear during virtual visits.

The band transmits live non-stress test readings comparable to in-office fetal surveillance to the provider while allowing the mother to view her data and insights in the paired app.

“Collaborating with Philips is an important step in our efforts to bring more comprehensive pregnancy care solutions to patients, providers and payers,” said Kelly Londy, Nuvo CEO, in a statement. “Philips has long been a leader in providing high-quality care in the obstetrics space, and we feel that this deep history, coupled with INVU’s unique ability to meet moms where they are, will be game-changing for the industry.”

Maternal mortality rates in the U.S., some of the highest in the developed world, are particularly elevated among Black and Native American women.

The White House released a fact sheet in December urging the healthcare industry to work to improve health outcomes for mothers and infants.

In November, more than 200 hospitals signed on to join the Department of Health and Human Services’ new maternal and infant health initiative to address these disparities by capturing data to improve care practices.

Philips previously invested in Babyscripts, a virtual care platform that uses tech and remote monitoring to deliver prenatal and postpartum care and enhance risk detection.

The health tech company participated in the startup’s $12 million series B round in September.

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AVIA Connect is the leading online resource for accurate, unbiased information about digital health companies and solutions. Our goal: To empower hospitals and health systems with the information they need to match with vendors who can meet their individual needs. We asked the top remote monitoring companies about their solutions and what they think the future of digital health looks like. No sponsored content or advertorials—just transparency and insights that decision-makers can use.

Nuvo takes aim at outdated models of pregnancy care with its INVU remote prenatal care platform, which allows pregnant patients to conduct asynchronous prenatal visits and fetal non-stress tests from home. The INVU sensor band, which is FDA-cleared for use during pregnancy at 32 weeks and beyond, securely sends physiological data to obstetric providers with accuracy comparable to in-office readings. Providers can review data through the clinician dashboard, while a parent-facing app provides personalized pregnancy insights to patients.

Ryan Kraudel, Nuvo’s Vice President of Marketing, leads global marketing for Nuvo and is responsible for all areas of marketing strategy and execution. He has over 20 years of experience achieving revenue and valuation targets in growth stage organizations. His previous career highlights include leading the marketing team for one of the market’s leading innovators in biometric sensors used in millions of consumer wearables.

Q: Can you tell us about your company and the challenges you are solving within the remote monitoring space?

A: Nuvo’s mission is to give every life a better beginning. Nuvo was founded to address the very intimate challenges that parents face throughout the various stages of pregnancy. We believe that both clinicians and parents would benefit from more and better real-time data to improve pregnancy outcomes and reduce worry and stress. INVU provides a remote pregnancy monitoring platform so that physicians can monitor and consult mothers as needed in the comfort of their own environments, no matter where they are.

Q: How does your company differentiate from other remote monitoring vendors?

A: Our FDA-cleared remote pregnancy monitoring and management platform offers clinical grade fetal monitoring that is self-administered in the safety and convenience of one’s home as part of a connected care regime with an OB team. We shift the point-of-care to the expectant mom, which facilitates access to high-quality remote care.

From a clinical perspective, existing standard methods for data collection have some notable limitations. The tocodynamometer (TOCO), which is the current standard of care, requires patients to travel to the clinic to be plugged into a machine that offers shallow and unreliable data. The gold standard of care, the intrauterine pressure catheter (IUPC), also requires the patient to travel to a clinic to be plugged into an invasive piece of equipment.

We have a novel method of capturing uterine activity which performs extremely well against the IUPC and is less invasive. We believe that INVU is the first FDA-cleared, prescription-initiated remote pregnancy monitoring and management platform that allows providers to conduct remote fetal non-stress tests.

In addition to our remote monitoring technology, we are developing an AI-powered big data platform that will enable personalized predictive care pathways and allow us to improve outcomes for all women.

Q: What are some of the biggest changes your company has seen around how health systems are approaching remote monitoring since 2020?

A: 2020 was an inflection point for everyone around the globe, particularly as it relates to healthcare. Clinicians, hospital systems and patients were forced to leverage online activity in every aspect of people’s lives, so patients and hospitals have seen the significant value that remote monitoring and healthcare can deliver. The demand for virtual pregnancy care solutions accelerated during the pandemic and continues to rise because time-pressed millennial moms want to be digitally empowered. We commissioned a survey in partnership with Wakefield Research that shows that 77 percent of new and expectant mothers would prefer to do some of their prenatal visits remotely (as long as their doctor could provide the same level of care). In the past two years, it's become evident the high cost of in-clinic care is unsustainable, while remote monitoring has shown not only clinical efficacy, but also improvements in quality of life for patients and providers.

Q: What does an ideal client look like? How are health systems best organized for success in remote monitoring?

A: An ideal client for Nuvo is a large healthcare organization, self-insured employer or payer that is responsible for a large number of pregnancies. There are a number of pressing needs and challenges that can be addressed by Nuvo, including geographic barriers to care (maternity deserts), health inequities/financial limitations and a shortage of OB-GYNs. Nuvo has seen great traction with organizations that are dealing with these challenges. We are also seeing the virtual care movement continue to shift to specialty care, with an increased demand stemming from the pandemic and desire among busy moms for telehealth options and easier access to care.

Q: What measurable outcomes have you seen from your clients who have prioritized remote monitoring?

A: Nuvo is democratizing access to the highest standard of pregnancy care by addressing the most common barriers to care:

• Concerns about potential exposure to illnesses like COVID-19, cold/flu and others
• Geographic barriers–over 50 percent of U.S. counties lack an OB-GYN
• Financial limitations
• Competing priorities, like jobs and other children, that make it difficult to find time for in-office visits

The demand for virtual pregnancy care solutions accelerated during the pandemic and only continues to rise.

Q: What major functional enhancements and/or product investments are you making in the near term to keep up with the evolution of remote monitoring?

A: We’re building on the INVU platform to accelerate innovation in pregnancy care. These investments are focused on three primary areas: pregnancy care decision support systems, population health tools, and novel AI models that generate unique insights into pregnancy care delivery.

Q: How is your company partnering with clients as reimbursements and use cases shift?

A: Nuvo has established collaborations with several clinical and technology leaders in the healthcare sector, including Axia Women’s Health, Unified Women’s Healthcare, University of Pennsylvania Medicine, University of Utah, Philips and Babyscripts. We work closely with our partners to ensure our collaborations are driving value in a highly dynamic healthcare environment.

Q: What are the biggest opportunities health systems should be thinking about this year when it comes to remote monitoring?

A: Health systems should be thinking about utilizing remote monitoring in pregnancy care. There are troubling trends in U.S. pregnancy care involving outcomes, access to care and costs:

• Outcomes: The U.S. ranks 52nd in global infant mortality rates, according to the World Factbook 2020
• Access to care: 50 percent of US counties do not have a practicing obstetrician, a rate that is expected to increase with fewer new OB-GYNs each year
• Cost: Pregnancy care is one of only four health conditions that drive over $100 billion in annual healthcare spending, while adoption of remote monitoring in pregnancy care has lagged compared to remote monitoring for other health conditions.

Remote monitoring has shown the potential to have a positive impact on each of these trends. Health systems that get ahead of this curve put themselves in a strong competitive position.

Q: How do you see remote monitoring evolving in 2022 and beyond?

A: Remote monitoring will continue to grow as clinicians get more comfortable with the technology and see the value it can provide, and as patients increasingly expect healthcare services to meet them where they are. In addition, remote monitoring will begin to unlock new insights into individual and population health by enabling analysis of real world patient data at scale.

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This article was originally published in AJOG in 2020 here.

Background

Access to prenatal care can be challenging due to physician shortages and rural geography. The multiple prenatal visits performed to collect basic fetal measurements lead to significant patient burden as well. The standard of care tools for fetal monitoring, external fetal heart rate monitoring with cardiotocography, as used today, must be applied by a medical professional in a healthcare setting. Novel tools to enable a remote and self-administered fetal monitoring solution would significantly alleviate some of the current barriers to care.

Objective

To compare maternal and fetal heart rate monitoring data obtained by ‘Invu system’ (a wireless, wearable, self-administered, fixed-location device containing passive electrical and acoustic sensors) to cardiotocography, toward a true remote fetal monitoring solution.

Materials and Methods

A prospective, open-label, multicenter study evaluated concurrent use of Invu and cardiotocography in pregnant women, aged 18 to 50 years, with singleton pregnancies ≥32+0 weeks’ gestation (NCT03504189). Simultaneous recording sessions from Invu and cardiotocography lasted for ≥30 minutes. Data from the 8 electrical sensors and 4 acoustic sensors in the Invu belt were acquired, digitized, and sent wirelessly for analysis by an algorithm on cloud-based servers. The algorithm validates the data, preprocesses the data to remove noise, detects heartbeats independently from the two data sources (electrical and acoustic), and fuses the detected heartbeat arrays to calculate fetal heart rate (FHR) and maternal heart rate (MHR). The primary performance endpoint was Invu FHR limit of agreement within ± 10 beats per minute (bpm) of FHR measured with cardiotocography.

Results

A total of 147 women were included in the study analysis. The mean (SD) maternal age was 31.8 ±6.9 years, and the mean gestational age was 37.7 ±2.3 weeks. There was a highly significant correlation between FHR measurements from Invu and cardiotocography (r = 0.92; P<0.0001). The 95% limits of agreement for the difference, the range within which most differences between the two measurements will lie, were -8.84 bpm to 8.24 bpm. Invu measurements of MHR were also very similar to cardiotocography and were highly significantly correlated (r = 0.97; P<0.0001). No adverse events were reported during the study.

Conclusion

Although captured by very different methods, the FHR and MHR outputs wirelessly obtained by the Invu system through passive methods were very similar to those obtained by the current standard of care. The limits of agreement for FHR measured by Invu were within a clinically acceptable ± 8 bpm of cardiotocography FHR. The Invu device uses passive technology to allow for safe, non-invasive and convenient monitoring of patients in the clinic and remotely. Further work should investigate how remote perinatal monitoring could best address some of the recent challenges seen with prenatal care and maternal and fetal outcomes.

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