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July 12, 2022

Stereotaxis seeks CE mark for robotically navigated catheter

The MAGiC catheter provides precision, stability and flexibility during the diagnosis and treatment of cardiac arrhythmias.

Stereotaxis has submitted an application seeking CE mark for its robotically navigated MAGiC catheter.

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The magnetic interventional ablation catheter has been designed for use in minimally invasive cardiac ablation procedures.

It has been developed to provide precision, stability and flexibility during the testing and treating of cardiac arrhythmias.

Developed in partnership with Osypka, a German medical device company, the catheter is used with Stereotaxis’s robotic systems.

Stereotaxis stated that the MAGiC catheter has many features that help to improve patient safety as well as efficacy, physician experience and procedural efficiency.

Stereotaxis chairman and CEO David Fischel said: “We are very pleased to reach this important milestone. This is a seminal event for Stereotaxis as a company and for the physician community that is pioneering the frontiers of robotics in electrophysiology.

“Our attention is focused on preparing for commercial launch of the catheter once we receive regulatory clearance.

“We look forward to the positive impact MAGiC can have on patients, physicians, providers and medical progress.”

MAGiC serves as a platform for future innovations and represents the first in a series of interventional devices that are being developed by the firm.

Stereotaxis seeks to make the catheter commercially available for robotic electrophysiology practices in Europe upon receipt of CE mark, which could be before the end of the year.

Separately, the company is also working on the submission of an application to the US Food and Drug Administration (FDA) to begin a prospective investigational device exemption (IDE) trial in the country.

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Medical Device Industry Landscape In Asia-Pacific

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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