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/PRNewswire/ Exero Medical has enrolled the first patient in its multi-center safety and feasibility study of the company s flagship product, the xBar.
By Yakir Benzion, United With Israel
The U.S. Food and Drug Administration has awarded an Israeli company the elite status of “FDA Breakthrough Designation” for developing a new system for the early detection of ‘anastomotic leaks’ – the most life-threatening complication from gastrointestinal surgery, Exero Medical reported Tuesday.
The National Institutes of Health says “Anastomotic leaks are among the most dreaded complications after colorectal surgery,” which tens of thousands of Americans undergo each year. When the intestines are sewn back together, the closure must be 100 percent, as any leakage can lead to fatal infections.
Founded in 2018, Exero Medical created a patent-pending implantable biodegradable wireless sensor designed to continuously monitor the GI tract near the surgical site, alerting physicians to potential anastomotic leakage after an operation. The system prevents complications by warning physicians of a potential leak, enabling early interven
Exero Medical s Smart Sensor Granted FDA Breakthrough Designation
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OR YEHUDA, ISRAEL, Dec. 15, 2020 /PRNewswire/ Exero Medical, developer of a wireless system for early detection of anastomotic leaks (AL) following gastrointestinal (GI) surgery, today announced that it has been granted FDA Breakthrough Designation – a status reserved for medical devices that provide more effective treatment or diagnosis of potentially life-threatening or irreversible conditions or diseases.
To achieve this status, Exero Medical demonstrated that its smart sensor for the early detection of potentially lethal AL following GI surgery, represents a breakthrough that may demonstrate substantial improvement over any available solution.