ENvizion wins US FDA 510(k) clearance for personalised feeding tube placement device.
M2 EQUITYBITES-April 3, 2019-ENvizion wins US FDA 510(k) clearance for personalised feeding tube placement device
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Israeli medical company ENvizion Medical reported on Tuesday the receipt of US FDA 510(k) clearance for the ENvue Electromagnetic Feeding Tube Placement System and ENvizion Feeding Tubes designed to enable accurate positioning of feeding tubes at the patient's bedside.
Globally, over 22 million nasal feeding tubes are placed annually and the main challenge is to place and position the tube correctly in the GI tract, avoiding the lungs. About one million tubes are misplaced in the lungs annually, which can cause death and lead to prolonged hospital stay with extensive additional hospital costs, added the company..
The company's new generation of electromagnetic placement technology with multiple sensors enables accurate enteral placement. The ENvue system creates a personalised roadmap of the patient's anatomy, displaying continuous tube tip position within the body during the insertion procedure. The healthcare professional has access to multiple views and warning indicators, which allows visual verification that the tube is proceeding along the correct path and not entering the lungs.
This US FDA market approval is based on the results from a clinical trial conducted at leading US hospitals, which demonstrated that the ENvue system is safe and effective, with no tube insertions into the pulmonary airways and no occurrence of guidance-related adverse events.
In conjunction, the company's ENvue Electromagnetic Feeding Tube Placement System, including nasoenteral feeding tubes and itsproprietary electromagnetic placement technology, supports the rising clinical need for a safe and accurate feeding tube placement solution, contributing to patient health and improved healthcare.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Apr 3, 2019|
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