Abbott’s Assert-IQ Insertable Cardiac Monitor Device receives approval from US FDA
United
States: Abbott
Labs, Inc. on Thursday, 18th May 2023 announced that it has received
its first Premarket Approval (PMA) for its companion monitoring device for
checking irregular heartbeat. Assert – IQ ICM which has a significant
advancement among the tools which are currently available in the market for the
diagnosis of irregular heartbeats. This device is inserted under the skin and
patients can lead a normal life like others. This device can detect hard-to-spot
irregularities and also help doctors to determine a treatment course. This
device has a small Bluetooth which is designed to connect with a transmitter of
the person’s cell phone and by using this connectivity a person can check heartbeats
every 20 seconds. According to the Centers for Disease Control and Prevention,
about 695,000 people in the United States died from heart disease in 2021 and every
year, about 805,000 people in the United States have a heart attack.
Assert-IQ offers two choices
with battery lives of at least three or six years, whereas many commercially
marketed ICMs only monitor a person's heart rhythm for a short period of time.
This gives clinicians new levels of flexibility in diagnostic monitoring. A
device with at least six years of battery life gives doctors the ability to
monitor over a longer period of time, even though the three-year option could
be chosen for more conventional monitoring such as detecting collapse,
heart palpitations, or the detection of irregular cardiac rhythms. When caring
for patients who are receiving therapy, have recently undergone a cardiac ablation
operation, or are at risk of developing new arrhythmias like atrial
fibrillation, this surveillance can be particularly crucial.
According to the Divisional Vice
President of Medical Affairs and Chief Medical Officer of Abbott's Cardiac Rhythm
Management Business,
“As the incidence of abnormal heart rhythms like atrial fibrillation continue
to rise, more doctors are turning to ICM technology to monitor their patients
remotely to better detect the cause of symptoms that can impact overall health
and quality of life. Until now, insertable cardiac monitors
have allowed for remote monitoring of patients but lacked the longevity needed
to monitor them long-term. Abbott's Assert-IQ ICM offers physicians a connected
health device that will help them provide the best care for their patients
while making more accurate and informed treatment decisions.”
According to TechSci Research, product launches play a
major role in companies’ growth to maintain a strong market position. Among
other companies Abbott launched product insertable cardiac monitoring device
can grow demand in the forecast period due to automatic detection and record of
abnormal heart rhythms, such as atrial fibrillation, bradycardia, tachycardia,
or pauses in the heart's electrical activity and wireless technology which will
help the company’s growth in a particular sector to promote their products. .
Product launches help to build the company’s value, aware people of their
products and offers. This can give them a better opportunity to enter the
healthcare industry for attracting potential consumers, investors as well as
competitors. If the company makes some innovative offers to address the needs
of the market, then they can gain customers the attraction of those who are
looking for the best products. The pre-approval of the Assert-IQ insertable
cardiac monitor device has been made by Abbott Lab, a medical device company and
one of the largest medical device company in the world. This company is
collaborating with other pharmaceutical and medical device companies for
promoting their products.