Le Lézard
Classified in: Health, Science and technology
Subjects: PDT, FDA

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

CAESAREA, Israel, Oct. 16, 2019 /PRNewswire/ -- Fidmi Medical Ltd. a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T) (OTCQX: TRNLY), announced today that it received 510K regulatory clearance from the United States Food and Drug Administration (FDA) for its low-profile enteral 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.

Fidmi Medical CEO Shahar Millis remarked, "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."

This is the second important milestone in two months, in September Fidmi announced their collaboration with CoapTech LLC from Baltimore, MD to allow a broader solution to tube-supported patients.

About Fidmi Medical

Fidmi Medical is an Israeli company founded in 2014, dedicated to developing enhanced feeding devices that offer easy insertion, replacement, and removal. The Company was founded with investment and support of The Trendlines Group's medtech incubator, and support from the Israel Innovation Authority. Fidmi Medical is currently raising a new investment round to bring the company to commercialization.

Shahar Millis, CEO, Fidmi Medical Ltd.
(972) 52-651-1132

Photo - https://mma.prnewswire.com/media/1011855/Fidmi_Medical_PEG_Tube.jpg


SOURCE Fidmi Medical Ltd.

These press releases may also interest you

at 16:10
Kite, a Gilead Company , today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the investigational chimeric antigen receptor (CAR) T cell therapy, KTE-X19, for the treatment of...

at 16:10
Twist Bioscience Corporation , a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today reported financial results and business highlights for the fourth quarter and full year fiscal...

at 16:10
Paycom Software, Inc., , a leading provider of comprehensive, cloud-based human capital management software, has again been recognized with an Employees' Choice Award as one of Glassdoor's 2020 Best Places to Work among large-sized U.S. companies....

at 16:10
Intersect ENT, Inc. , today announced that management will participate in the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2020 at the Westin St. Francis Hotel in San Francisco, and will present at 1:30 p.m. PT. A replay...

at 16:05
McAfee, the device-to-cloud cybersecurity company, today announced it will host the CEO Action "Check Your Blind Spots" mobile tour at the company's headquarters in Santa Clara, California on Wednesday, December 11, 2019. The tour bus is an...

at 16:00
WorkFusion, a top provider of Intelligent Automation software, today announced it received the highest score among 18 vendors for the "Augment Knowledge Workers" use case in Gartner's "Critical Capabilities for Robotic Process Automation" (RPA)...

News published on 16 october 2019 at 08:00 and distributed by: