General News

Zio cardiac monitoring patch detects AF, study finds

July 30, 2018 by Kathy Dion Leave a Comment

SAN FRANCISCO – Use of iRhythm’s Zio cardiac monitoring patch detects asymptomatic atrial fibrillation at a higher rate than routine care, according to a study published recently in JAMA.

Results of the mHealth Screening to Prevent Strokes study, which was conducted at the Scripps Translational Science Institute in partnership with Aetna and Janssen Pharmaceuticals, showed AF was newly diagnosed in 6.7% of patients who were actively monitored by the Zio continuous monitoring patch in a home-based study, as compared to 2.6% in those who received routine care.

“Our study shows an almost threefold improvement in the rate of diagnosis of AF in those actively monitored compared to usual care,” said Dr. Steven Steinhubl, an author of the study. “Diagnosing AF more effectively can enable the initiation of effective therapies and help reduce strokes and death.”

The study also found that 4% of patients in the Zio monitored group were found to have potentially actionable arrhythmias other than AF.

The mHealthSPS study involved 5214 eligible Aetna members who were identified through claims data to have risk factors for AF but had not been previously diagnosed. One-third of individuals were enrolled through a web-based platform to undergo either immediate or delayed active electrocardiograph monitoring at home for up to four weeks with a Zio XT patch monitor.

Using the digital Zio monitoring service by iRhythm enabled the research team to approach a large, geographically diverse population of at-risk individuals and include people who otherwise may have no access to participation in clinical trials because they do not live close to a research center, said Steinhubl.

“This study demonstrates the utility of a digital approach not only to diagnosing asymptomatic AF, but to the clinical research field as a whole,” he said. “We hope that it will set a precedent for future real-world, participant-centric clinical trials that leverage the power of digital medicine technologies.”

DHS supports development of at-home flu tests

July 23, 2018 by Kathy Dion Leave a Comment

WASHINGTON – Two potential diagnostic tests for influenza, designed to be purchased over-the-counter for home use, will move into advanced development with new support from the U.S. Department of Health and Human Services.

The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), is partnering with Cue Health, Inc., of San Diego, and Diassess, Inc., of Emeryville, Calif., to develop the testing devices.

“Empowering people to answer the basic question, ‘Do I have the flu?’ without leaving home could have a profound effect on controlling and treating influenza, whether it’s seasonal or a wide-spread pandemic,” said Rick Bright, director of BARDA, in a statement. “Putting that power in patients’ hands could transform the speed and delivery of care. In a pandemic, that equates to lives saved and stronger national health security.” BARDA will provide $14 million to Cue Health and $10 million to Diassess for advanced development of diagnostic tests for influenza A and B viruses that are being developed for purchase over-the-counter for administration by professionals. The agreement with Cue Health can be extended for up to a total of $30 million over 60 months, and the agreement with Diassess for up to a total of $21.9 million over 60 months, said Bright.

Both companies are designing their devices and tests to be inexpensive, simple for consumers to use and able to provide results within 25 minutes. Both devices leverage mobile technology so that patients who test positive for influenza can receive a telemedicine consultation and, if needed, a prescription for antiviral drugs without leaving home.

The devices also may include the capability to report de-identified influenza data to local health departments in real-time, which would give public health authorities earlier warnings of possible outbreaks or pandemics, while safeguarding patient privacy.

The Diassess testing device would be disposable and battery-powered for use in the field, where resources may be limited during public health emergencies. Cue Health also is developing its device to test for other viruses, including Zika and HIV.

Octave Bioscience secures $14M for MS platform

July 20, 2018 by Kathy Dion Leave a Comment

MENLO PARK, Calif. – Octave Bioscience, a developer of a fully integrated care management solution that delivers insights for patients with neurodegenerative diseases, has completed its Series A funding of $14 million. The company previously raised $2.5 million in seed funding.

The funding will allow Octave Bioscience to complete development of its a digital health platform and begin to evaluate its impact in its initial disease state, multiple sclerosis.

“Multiple sclerosis is a high-cost disease that is highly variable,” said Dr. Thomas Hawes, an Octave Bioscience board member, in a statement. “Octave’s care management solution promises to transform neurodegenerative diseases by providing expanded insights into a patient’s specific disease stage, severity and progression, while accessing practice protocols and evidence-based care insights to improve patient outcomes and quality of life.”

Octave Bioscience’s care management solution was designed to start with a measurement system that includes assessing a patient’s biology through select biomarkers tied to inflammatory disease activity and neurodegeneration. It continuously tracks patient symptoms and disease trajectory using sensors and mobile tools.

Octave Bioscience also recently announced the appointments of two new board members: George Scangos, CEO of Vir Biotechnology; and Dr. Michael Pellini, managing partner at Section 32.

Study shows use of insulin pump reduces hospital admissions

July 18, 2018 by Kathy Dion Leave a Comment

DUBLIN – First-year results from a partnership between Medtronic and UnitedHealthcare show that use of Medtronic’s MiniMed 630G insulin pump reduced preventable hospital admissions for people with diabetes by 27%.

The partner study included more than 6,000 UnitedHealthcare members with diabetes who used standalone pumps and pumps integrated with continuous glucose monitors, as well as members who are on multiple daily injections of insulin. “These positive results provide further evidence of the benefits of both automated insulin delivery and of value-based healthcare models” said Hooman Hakami, executive vice president and president of the Diabetes Group at Medtronic, in a statement. “Through this unique partnership, Medtronic and UnitedHealthcare have demonstrated a commitment by both organizations to prioritize innovation that improves health outcomes and lowers healthcare costs.”

In 2016, UnitedHealthcare and Medtronic announced an expanded relationship that gave UnitedHealthcare members with diabetes access to advanced insulin pump technologies and comprehensive support services offered by Medtronic. These offerings currently include the company’s most advanced MiniMed 670G hybrid closed-loop system featuring SmartGuard technology and Guardian Sensor 3, which automates the delivery of a personalized amount of basal insulin every five minutes based on real-time sensor glucose values.

“Our hope is that this agreement is just the beginning and that the entire health care community follows UnitedHealthcare’s lead to not only champion innovation in diabetes that has a clear and measurable tie to better outcomes and lower cost, but to also drive business models that reward those results as they are achieved,” said Hakami.

The results reflect the first year of a multiyear initiative between UnitedHealthcare and Medtronic. Both quality of care and cost will continue to be evaluated over the duration of the relationship, providing additional opportunities for more people enrolled in UnitedHealthcare plans to better manage their diabetes and for quality care to be delivered in a more cost-effective manner.

“These results show that patients with diabetes can benefit from using insulin pumps and comprehensive support services, thereby increasing the quality of the care they receive and reducing hospital admissions, as well as costs,” said Dr. Peter Pronovost, chief medical officer at UnitedHealthcare, in a statement. “The first-year results are encouraging, and we will monitor patients using Medtronic pump therapies to ensure we continue to see improved quality of care, fewer hospitalizations, and lower costs.”

Q&A: Abbott Laboratories on the impact of reimbursement for smartphone-connected CGM

July 17, 2018 by Kathy Dion Leave a Comment

‘It’s an important step for patients, caregivers and providers’

ABBOTT PARK, Ill. – After hearing from a number of patients and other stakeholders, the Centers for Medicare & Medicaid Services recently reversed its position on reimbursement for smartphone-connected continuous glucose monitors.

The agency will modify Medicare’s published coverage policy for CGMs to support their use in conjunction with a smartphone, including for data sharing.

Industry leaders were quick to applaud the decision, including Glenn Johnson, general manager of market access, and Joel Goldsmith, senior director of digital platforms, at Abbott Diabetes Care, which makes the Freestyle Libre CGM system.

HHTN:How will the decision by CMS impact the continuous glucose monitoring industry?

JOHNSON:This is an important step forward in simplifying diabetes management and yielding the way for future advances in smartphone-enabled continuous glucose monitoring technology. It reinforces the importance of our efforts to make this technology available for U.S. users in the near future.

HHTN:How will it benefit providers and patients?

JOHNSON:The CMS decision is an important step not just for patients, but also for caregivers and providers. For some people with diabetes, caregivers are there to provide support when needed, while others depend on their caregivers for daily tasks, such as medication intake and meals. Smartphone-enabled CGM technology provides those caregivers with peace of mind by allowing them to remotely follow their loved ones’ glucose levels and monitor in real time. Physicians can closely follow their patient’s glucose trends and patterns to make treatment decisions and help improve outcomes.

HHTN:What are some challenges standing in the way of a wider adoption of home health technology like continuous glucose monitors?

JOHNSON:Cost and reimbursement decisions play a big role in whether new health technologies can be widely adopted. At Abbott, our main priority is to provide patients with access to an innovative and affordable product that eliminates painful routine fingersticks for people living with diabetes. We believe that to be truly innovative, you have to find a way to become available to the masses, not just to an elite few who can afford it.

HHTN:How is technology impacting the delivery of home health care today?

GOLDSMITH:Technology has transformed healthcare delivery in the past few years by enabling us to bring new solutions to market that address key health challenges and improve patient outcomes. The diabetes market specifically has been steadily evolving as patients and health care providers are embracing wearable technologies for glucose monitoring; they are now connected at a much higher level and work in tandem to optimize diabetes management.

HHTN:What will it look like in the future?

GOLDSMITH:We believe that health care technology will continue to evolve to provide patients with actionable insights to improve disease management and that we are at the helm of pioneering how data can translate into improved outcomes by enabling people with diabetes to make more informed decisions about their care. This is just the beginning.

VC digital health funding nears $5B, according to report

July 17, 2018 by Kathy Dion Leave a Comment

AUSTIN, Texas – Global venture capital funding for digital health companies reached a record $4.9 billion in the first half of 2018, according to a recent report by Mercom Capital Group, a global communications and research firm.

The report found that VC funding for digital health companies was 22% higher year-over-year with 383 deals. During the same time period last year, funding reached $4 billion with 359 deals.

The unprecedented growth is not expected to slow down, according to Raj Prabhu, CEO and co-founder of Mercom Capital Group.

“We expect the record to continue and break 2017’s record of $7.2 billion in total VC funding,” he said.

Digital health companies have now received $30.6 billion with 3,833 deals since 2010, according to data tracked by Mercom.

The report found that the top funded areas in the first half of 2018 were: data analytics ($911 million); telemedicine ($701 million); clinical decision support ($582 million); mHealth apps ($535 million); wearables ($308 million); mobile wireless ($272 million); and wellness ($201 million).

The top VC deals in the first half 2018 were: $291 million raised by American Well; $240 million raised by Heartflow; $200 million raised by Helix; $200 million raised by SomaLogic; $146 million raised by PointClickCare; $110 million raised by Collective Health; $105 million raised by Livongo Health; $100 million raised by DXY; and $80 million raised by Tempus.

Prabhu said developments like the Centers for Medicare & Medicaid Services’ proposal for Medicare to pay for telehealth and the U.S. Food and Drug Administration’s approval of artificial intelligence-based apps show the space is maturing and getting the attention it deserves from regulators, with others following suit.

“Tech giants like Amazon, Google, Apple and others are also making serious inroads into the digital health space, making the sector more mainstream and validating the sector and investments,” he said.

mHealth solutions win AMA challenge

July 12, 2018 by Kathy Dion Leave a Comment

CAMBRIDGE, Mass. – Three mobile health monitoring technology companies were recognized recently as the top three solutions submitted to the American Medical Association’s Health Care Interoperability and Innovation Challenge sponsored by Google Cloud.

The three winning solutions selected from among the semi-finalists share $50,000 in Google Cloud credits to accelerate their solutions. They are:

HealthSteps (first place, $25,000): a mobile health platform that focuses on the delivery of information between patient and provider to improve health outcomes through a digital care plan and real-time data.
I-deal Health (second place,$15,000): a digital platform that empowers patients to visualize their personal risk for multiple diseases, choose goals to reduce their risk, and close the loop between patients and clinicians to achieve success. Through individualized treatment derived from EHR data, patients can work to focus their efforts through the help of the I-deal Health mobile application.
FUTUREASSURE(third place, $10,000): A system that uses validated data to implement mobile technology into standard clinical workflow. It collects clinical and research data to assess a patient’s risk for surgery and can predict surgical outcomes previously not compared.

The three winning ideas were selected by judges to best demonstrate uses of patient-generated health data to have maximum impact on improving physician workflow, improving clinical outcomes and reducing cost in the health care system.

“The AMA issued the challenge to inspire the creation of novel mobile technology that demonstrates innovative uses of health data to support the long term wellness of patients,” said Dr. Michael Hodgkins, chief medical information officer of the AMA, in a statement. “The top solutions chosen in the AMA Challenge have the potential to be transformational innovations that effectively share meaningful medical data between patients and physicians and create a healthier nation.”

mHealth devices accurately measure cardiovascular risk, study finds

July 11, 2018 by Kathy Dion Leave a Comment

LA JOLLA, Calif. – Mobile health technologies can accurately measure and track cardiovascular risk factors, according to a recent study by researchers at the Scripps Translational Science Institute.

The study used digital activity trackers, sleep monitors, electronic blood pressure devices and other devices to assess cardiovascular risk factors outside of the clinical setting, along with demographics, medication adherence and stress levels.

“The emergence of mobile health technologies offer the new ability to track both traditional cardiovascular risk factors and other factors that increase a person’s risk for cardiovascular disease at home and at high sampling rates,” said Brian Modena, first author of a paper on the study that was published recently in the journal Hypertension. “Identifying new ways of monitoring cardiovascular risk factors is critical to reducing the burden of this disease and strains on healthcare systems across the globe.”

The study found that measurements from the mobile devices closely matched national averages or prior studies performed in very controlled clinical settings, supporting their accuracy and reliability, Modena said.

The study was conducted in collaboration with consumer electronics provider Withings, which identified eligible study participants through a company database of owners of Withings health tracking devices. A total of 255 individuals were enrolled and asked to measure blood pressure, heart rate, pulse wave velocity and weight two days a week for 17 weeks. All measurements were transmitted wirelessly through a smartphone app to a secure database.

This was also the first study to successfully assess and track pulse wave velocity, an indicator of cardiovascular risk, outside of a controlled clinical setting using new smart weight scales.

“With high adherence, satisfaction and participant engagement, this proof-of-concept study required minimal study personnel and no participant training, thereby making it likely scalable to much larger populations,” said Steven Steinhubl, director of digital medicine at the Scripps Translational Science Institute and senior author on the study, in a statement.

AMA guidelines help clarify AI’s potential, experts say

July 10, 2018 by Kathy Dion Leave a Comment

CHICAGO – Experts are applauding the American Medical Association’s recently issued policy on how to incorporate artificial and augmented intelligence into health care.

“The new guidelines get at one of the core challenges of integrating new technologies into health care—how we develop things that are actually going to be used,” said Dr. Cory Kidd, founder and CEO of Catalia Health, providers of the Mabu digital health platform.

The policy on AI states that the AMA will: leverage its ongoing engagement in digital health and other priority areas for improving patient outcomes and physician professional satisfaction to help set priorities for health care AI; identify opportunities to integrate the perspective of practicing physicians into the development and implementation of health care AI; encourage education for patients, physicians, medical students, other health care professionals in the promise and limitations of health care AI; and explore the legal implications of health care AI.

When new technologies like AI are introduced to health care, it’s important to ensure their proper use and safety, said Rich Berner, CEO of telehealth provider MDLive.

“We’re pleased to see the AMA is taking proactive stance to advance the use of AI to do what’s best for the patient and to provide quality care,” he said.

AI can be a big component in helping the industry rethink and disrupt health care by helping to automating routine clinician tasks, thereby making providers more efficient and able to see more patients, Berner said.

“AI will help us solve our physician shortage problem and make health care better for the patient and the provider, as well as lower costs and improve quality,” he said.

Guidelines like those developed by the AMA can also bring a greater understanding of AI’s potential, said Kidd.

“A lot of health care technology comes from developers trying to create solutions at a high level, but not from a day-to-day perspective,” he said. “Guidelines like these help connect the opportunities that technology can provide for automation and efficiencies with the clinicians who are actually going to use them.”

Crowdsourcing health data informs community impact of asthma

July 10, 2018 by Kathy Dion Leave a Comment

‘It’s a huge opportunity’

MADISON, Wis. – Results from a public-private partnership this year between digital inhaler provider Propeller Health and the city of Louisville, Ky., show that digital health tools can help reduce the community burden of asthma.

“AIR Louisville demonstrated the value of crowdsourced health data, influencing positive outcomes from an individual level up to the policy-making level,” said Meredith Barrett, vice president of research at Propeller Health and co-author of the paper. “We think the potential for this collaborative approach is huge.”

AIR Louisville was one of the largest studies of asthma conducted in a real world setting, Barrett said. More than 20 public, private and philanthropic organizations collaborated to use digital health technology like inhaler sensors and a digital health platform to: monitor where and when local residents used their inhaled medications for asthma, assess the environmental conditions that might have influenced asthma symptoms, and share those findings with participants and city decision-makers.

Results show that participants experienced several positive clinical outcomes, including a 78% reduction in rescue inhaler use and a 48% improvement in symptom-free days. The hundreds of thousands of real-world data points on inhaler use, combined with environmental data, also informed municipal policy recommendations.

Barrett said the project helped asthma patients better understand how environmental triggers impact their condition and then inform their conversations with their health providers.

“It improved their daily experience with their disease so they could live their lives without being held back by their symptoms,” she said. “It helped people be more confident in the self-management of their disease.”

Barrett said the project has drawn attention domestically and internationally from cities interested in conducting similar programs.

“This is a model that could also be replicated for other diseases that have environmental impact,” she said. “It’s a huge opportunity.”