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July 9, 2021

FDA approves AliveCor’s ECG device for QTc interval measuring

KardiaMobile 6L can obtain an ECG in just 30 seconds, which can then be used for manual QT interval calculation. 

The US Food and Drug Administration (FDA) has granted 510(k) clearance to AliveCor’s electrocardiogram (ECG) device, KardiaMobile 6L, for the measuring of QTc interval in patients by healthcare experts.

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KardiaMobile 6L is the first-ever handheld ECG device to receive FDA approval for QTc measurement, the company noted.

A heart rate corrected interval, QTc indicates the integrity of the electrical recharging system of the heart.

With this latest approval, healthcare professionals can use the KardiaMobile 6L device to get an ECG in 30 seconds, which can be used to manually calculate QT intervals in patients.

AliveCor noted that an ECG can be quickly and conveniently obtained using this device at a healthcare professional’s office or even remotely by the patient.

In March 2020, KardiaMobile 6L technology received FDA approval to measure QTc and detect potentially dangerous QT prolongation in Covid-19 patients.

AliveCor CEO Priya Abani said: “Patient safety is paramount, and this is why we are proud to offer physicians the ability to monitor QTc through the convenience and quality of our device.

“It is our hope that this important FDA clearance will help healthcare professionals identify and save patients from this potentially life-threatening condition.”

Apart from the KardiaMobile 6L, AliveCor also provides the InstantQT service, which calculates QT intervals rapidly and precisely using FDA-cleared, ECG processing software.

The service can be used by healthcare professionals to identify serious QT prolongations in patients.

In a separate development, the FDA has granted 510(k) clearance to Fujifilm’s latest image enhancement technology, the Oxygen Saturation Endoscopic Imaging System.

The system can enhance visualisation during gastrointestinal, colorectal and advanced endoscopy as well as surgical procedures.

Leveraging laparoscopic and/or endoscopic imaging, the new technology facilitates real-time visualisation of haemoglobin oxygen saturation (StO₂) levels present in tissues.

Measuring StO₂ levels aids surgeons in the detection of potentially ischemic tissue and the prevention of tissue necrosis.

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GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
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