Enabling closer remote patient monitoring and
reduced healthcare costs
WILMINGTON, Mass., March 5,
2024 /PRNewswire/ -- Analog Devices,
Inc. (Nasdaq: ADI) today announced U.S. Food and Drug
Administration (FDA) 510(k) clearance and the commercial launch of
the Sensinel™ Cardiopulmonary Management (CPM)
System. The compact wearable device is a non-invasive, remote
management system that captures cardiopulmonary measurements for
chronic disease management such as heart failure. It is the first
FDA clearance the company has received in its 59-year history.
"Since our founding, ADI has focused on accelerating
breakthroughs that enrich lives through innovative products,"
said Patrick O'Doherty, Senior Vice
President of Digital Healthcare at ADI. "By combining our wearable
vital signs sensing and signal processing technology with
cardiologist-inspired algorithms to precisely determine a
congestive heart failure patient's daily state of health, we
developed the Sensinel CPM System. This innovative service-based
product has the potential to open up several billion dollars of
green-field market opportunity for ADI while improving patient
care, streamlining clinician workflows, and reducing healthcare
cost."
More than 6 million Americans are living with heart failure
today, and this number is estimated to rise to nearly 8 million by
2030.¹ Heart failure currently costs Americans approximately
$30 billion each year, and this is
expected to rise to almost $70
billion by 2030.¹ Approximately 80% of those costs are due
to hospitalization.¹ Other prior solutions measuring similar
parameters have shown the ability to reduce hospital admissions.
However, oftentimes these solutions are either invasive and/or do
not provide sensitive and specific enough data to make a meaningful
clinical impact. This data is critical to allow the care team to
predict an event early enough in advance to potentially avoid a
costly hospitalization for the patient.
The Sensinel CPM System is the next-generation solution for
management of cardiopulmonary diseases like heart failure. It is
equipped with a set of physiological indicators to help care teams
better manage chronic conditions early and remotely, as well as in
a precise manner. Patients self-apply ADI's Sensinel CPM Wearable
which they only wear for three to five minutes in a home care
setting. The device then captures data about their cardiopulmonary
health. This data is automatically uploaded to ADI's Sensinel CPM
Cloud Platform using a cellular link (without the need for a
patient-supplied Internet connection) and is then further analyzed
using ADI's Sensinel CPM Intelligent Algorithms in the cloud.
"Early detection of physiological changes is critical for
clinicians to prevent a heart failure hospitalization," said Dr.
Sean Pinney, Chief of Cardiology at
Mount Sinai Morningside in New York
City. "ADI's Sensinel CPM System is a highly accurate,
reproducible, and reliable solution to help improve predictive
care."
"When managing chronic conditions like heart failure, it is
critical to adjust treatment early to get the condition under
control without the need for hospitalization. Other existing
non-invasive solutions are not specific enough to provide the data
a clinician needs to be effective for early intervention," said Dr.
Venu Gopinathan, ADI Fellow and
Managing Director of Medical Products at ADI. "Our new
cardiopulmonary system is designed to fit seamlessly into the
workflow of care and perform a variety of physiological
measurements that allow care teams to make early clinical
decisions, without subjecting them to information overload."
ADI's Sensinel CPM System is now commercially available. For
more information, visit https://sensinel.analog.com.
About Sensinel by Analog Devices™
Sensinel by Analog
Devices – a brand new wearable healthcare line – aims to
fundamentally transform how chronic disease is managed to promote
quality of life in an affordable manner. The first product, the
Sensinel CPM System, is a non-invasive, at-home
solution that captures cardiopulmonary measurements for
chronic disease management such as heart failure. Analog Devices,
Inc., the company behind Sensinel, is a global semiconductor leader
with more than 50 years of expertise in the healthcare industry,
particularly within sensing, measuring, computing, connecting, and
powering to accelerate human breakthroughs that enrich lives and
the world.
About Analog Devices, Inc.
Analog Devices, Inc.
(NASDAQ: ADI) is a global semiconductor leader that bridges the
physical and digital worlds to enable breakthroughs at the
Intelligent Edge. ADI combines analog, digital, and software
technologies into solutions that help drive advancements
in digitized factories, mobility, and digital healthcare,
combat climate change, and reliably connect humans and the world.
With revenue of more than $12 billion
in FY23 and approximately 26,000 people globally working alongside
125,000 global customers, ADI ensures today's innovators stay Ahead
of What's Possible. Learn more at www.analog.com and
on LinkedIn and Twitter (X).
All trademarks and registered trademarks are the property of
their respective owners.
Forward-Looking Statements
This press release contains forward-looking statements, which
address a variety of subjects including, for example, statements
regarding applications, benefits and growth opportunities related
to Sensinel or other healthcare wearables; and other future events.
Statements that are not historical facts, including statements
about our beliefs, plans and expectations, are forward-looking
statements. Such statements are based on our current expectations
and are subject to a number of factors and uncertainties, which
could cause actual results to differ materially from those
described in the forward-looking statements. The following
important factors and uncertainties, among others, could cause
actual results to differ materially from those described in these
forward-looking statements: the effects of business, economic,
political, legal and regulatory uncertainty or conflicts upon our
global operations; changes in demand for semiconductors and the
related changes in demand and supply for our products;
manufacturing delays, product availability and supply chain
disruptions; our future liquidity, capital needs and capital
expenditures; our development of technologies and research and
development investments; our ability to compete successfully in the
markets in which we operate; changes in our estimates of our
expected tax rates based on current tax law; adverse results in
litigation matters; the risk that we will be unable to retain and
hire key personnel; security breaches or other cyber incidents;
unanticipated difficulties or expenditures relating to integrating
Maxim Integrated Products, Inc. ("Maxim"); uncertainty as to the
long-term value of our common stock; and the risk that expected
benefits, synergies and growth prospects of acquisitions, including
those from our acquisition of Maxim, may not be fully achieved in a
timely manner, or at all. For additional information about factors
that could cause actual results to differ materially from those
described in the forward-looking statements, please refer to our
filings with the Securities and Exchange Commission, including the
risk factors contained in our most recent Annual Report on Form
10-K. Forward-looking statements represent management's current
expectations and are inherently uncertain. Except as required by
law, we do not undertake any obligation to update forward-looking
statements made by us to reflect subsequent events or
circumstances.
References
1. American Heart Association. Understand
your risk for heart failure. American Heart Association website.
Published May 9, 2017. Updated
June 13, 2023. Accessed March 5, 2024.
https://www.heart.org/en/health-topics/heart-failure/causes-and-risks-for-heart-failure/understand-your-risk-for-heart-failure
CONTACT:
Ferda
Millan
Global PR and External Communications
Analog Devices
Ferda.Millan@analog.com
(408) 373-1854
Michael Lucarelli
Vice President, Investor Relations and FP&A
Analog Devices
Investor.Relations@analog.com
(781) 461-3282
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SOURCE Analog Devices, Inc.