Fidmi Medical earns FDA clearance

Editor’s note: News of this announcement appeared on FDANews, Guided Solutions, Medgadget, NS Medical Devices, and Yahoo! Finance.

Fidmi Medical Receives FDA Regulatory Clearance for Low-Profile Enteral Feeding Device

Fidmi Medical announced that it received 510(k) regulatory clearance from the United States Food and Drug Administration (FDA) for its low-profile enteral feeding device.

Fidmi Medical low-profile feeding device

Fidmi Medical’s low-profile PEG tube for easier insertion, replacement and comfort

Gastrostomy tubes, which help patients receive long-term nutritional support, are typically placed endoscopically and need to be replaced every 3-6 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 health care system.

Fidmi Medical’s innovative low-profile gastrostomy system is unique in that it can be utilized for both initial placement and replacement and has several features which make it more durable and comfortable for patients. Gastrostomy tubes very often get dislodged or clogged, promoting infection, and need to be replaced frequently. Fidmi’s improved low-profile gastrostomy tube is placed just like any standard percutaneous endoscopic gastrostomy (PEG) tube but has an easily replaceable inner tube which can be changed by patients without the need to re-enter the healthcare system for replacement procedures. This will result in fewer complications with patients’ gastric tubes, therefore potentially reducing healthcare costs for payers and healthcare systems; as well as providing a substantial improvement in quality of life for patients and their caregivers.

Receiving FDA clearance is a remarkable milestone for us. FDA clearance allows us to enter the US market; to provide improved patient quality of life and impact the ease, efficiency and confidence of clinicians’ work.

Fidmi Medical CEO Shahar Millis

This is the second important milestone for the company in two months: In September, Fidmi announced its collaboration with CoapTech.