Cutting-edge tool analyzes data from cardiac
remote monitoring devices to assess whether a patient is at high
risk of experiencing worsening heart failure, enabling medical
teams to intervene and avoid hospitalization.
CAMBRIDGE, Mass., May 17, 2024
/PRNewswire/ -- Implicity, a leader in remote patient
monitoring and cardiac data management solutions, announced it has
received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for a new groundbreaking algorithm,
SignalHF1, used in its remote monitoring
solution.
Implicity was the first private company authorized to access the
Health Data Hub, one of the largest databases of patients with
heart disease in the world. Based on the Health Data Hub complete
medico-administrative database and comprehensive datasets from
Implicity's AI-based remote monitoring platform, the Implicity team
trained and validated a machine learning algorithm that assesses
the risk of future heart failure events, enabling physicians to
intervene before a patient requires hospitalization.
"Heart failure remains a significant healthcare challenge,
contributing to approximately one million hospitalizations each
year. Preventing even a portion of these would be a game-changer in
cardiac care," said Dr. Arnaud
Rosier, Implicity's CEO and cardiologist. "SignalHF is
an innovative and effective tool that physicians can use to assess
risk of hospitalization due to heart failure earlier, enabling
interventions that can lead to better outcomes and reduce hospital
admissions."
SignalHF is unique in that the manufacturer-agnostic solution
can be used to analyze data collected from a variety of Cardiac
Implantable Electronic Devices (CIED), including implantable
cardiac defibrillators (ICD), pacemakers (PM) and cardiac
resynchronization therapy devices (CRT-P, CRT-D) from
Biotronik, Boston Scientific and Medtronic. SignalHF is the first
pacemaker compatible heart failure algorithm on the market. The
algorithm can accurately identify trends indicating whether a
patient's condition is worsening. Care teams receive an automatic
alert when the patient's risk score crosses an established
threshold, indicating an individual is at high risk of experiencing
heart failure and being hospitalized in the near future.
"Comprehensive heart failure management includes treatment,
prevention, and personalization. Implicity's solution is part of
this approach. Our alerts are generated in context with a patient's
medical profile to help personalize care management plans.
Furthermore, 75% of the alerts preceding a patient hospitalization
are sent at least 14 days in advance – offering a
two-week window to adjust medications or take proactive measures,"
said Issam Ibnouhsein, Head of Data at Implicity.
About Implicity
Implicity provides a remote monitoring
and research platform used by Independent Diagnostic Testing
Facilities and cardiac electrophysiology centers to deliver better,
high-quality care for their patients with Cardiac Implantable
Electronic Devices. Implicity's platform aggregates, normalizes,
and standardizes data from any implantable cardiac device
across all manufacturers. Furthermore, Implicity carries out
R&D on AI-based algorithms aiming at improving patient
care and serving the future of preventive medicine.
www.implicity.com
Media Contact:
Samantha
Choinski
eMedia Junction
860-301-5058
samantha@emediajunction.com
1 SignalHF is an FDA-cleared Class II
medical device. See the instructions for use for more
information.
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SOURCE Implicity