Fidmi Medical Ltd revealed on Wednesday the receipt of the US Food and Drug Administration's (FDA) 510K regulatory clearance for its low-profile enteral feeding gastrostomy device for easier insertion, replacement and comfort in patients in need of nutritional support.
According to the Israeli company, the gastrostomy tubes are typically placed endoscopically and need to be replaced every three to six months. Complications such as clogging and dislodgement are common, resulting in inadequate nutrition and medication delivery, numerous tube replacements, hospitalizations, and a substantial financial drain on patients and the healthcare system.
The company's low-profile gastrostomy system can be utilized for both initial placement and replacement and is more durable and comfortable for patients, Fidmi Medical said. The improved low-profile gastrostomy tube has an easily replaceable inner tube that can be changed by patients without the need to re-enter the healthcare system for replacement procedures. This will result in fewer complications, reduce healthcare costs for payers and healthcare systems, and provide a substantial improvement in quality of life for patients and their caregivers.
A portfolio company of The Trendlines Group Ltd (SGX:42T) (OTCQX:TRNLY), Fidmi Medical is dedicated to developing enhanced feeding devices that offer easy insertion, replacement and removal.
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