News
Article
Company eyes FDA clearance for expanding use of real-time navigation technology
Pediatric feeding tube guidance system wins patent: ©Sergey Novikov - stock.adobe.com
NanoVibronix Inc. announced that its subsidiary, ENvue Medical Holdings LLC, has secured a U.S. patent for its pediatric feeding tube guidance system. The patent—U.S. Patent No. 12,324,632—covers a system that provides real-time navigational data to assist clinicians during feeding tube placement in pediatric patients.
The newly granted patent, titled “Insertion Device Positioning Guidance System,” is aimed at helping clinicians manage the anatomical and procedural challenges of placing feeding tubes in children, especially among high-risk groups such as preterm infants and critically ill pediatric patients. The technology is designed to reduce the need for confirmatory imaging like X-rays by using electromagnetic tracking to guide and confirm placement in real time.
“We believe the addressable market for our pediatric navigation platform is substantial,” said Dr. Doron Besser, CEO of NanoVibronix. “This patent reflects our commitment to addressing this market opportunity by developing more precise, real-time enteral access solutions tailored to the needs of vulnerable patient populations.”
In the U.S. alone, over 1.5 million pediatric feeding tube procedures are performed annually, representing a market opportunity exceeding $150 million for both capital equipment and disposable components. ENvue Medical’s system is currently FDA-cleared for adult patients, and the company is planning to seek 510(k) clearance to expand its use to pediatric care.
The patented technology is part of ENvue’s Enhanced Navigation platform, which allows clinicians to visualize feeding tube placement as it happens—improving safety and workflow while minimizing radiation exposure.
ENvue Medical’s newly patented navigation system reflects a broader trend of innovation in pediatric medical devices, where precision, minimally invasive methods, and child-specific solutions are reshaping standards of care.
In recent years, companies have introduced a range of breakthrough devices targeting the unique needs of pediatric patients. These include wearable cardiac monitors adapted for smaller bodies, smart infusion pumps with pediatric dosing safeguards, and miniaturized imaging tools for non-invasive diagnostics in neonates.
Among the notable advancements is the development of pediatric-friendly MRI machines that reduce noise levels and scan times, helping to alleviate anxiety and the need for sedation in children. Another example is the use of 3D-printed airway splints, which have been life-saving in infants with severe tracheobronchomalacia—a condition where the airway collapses.
In recent years, the FDA granted breakthrough designation to a number of pediatric-focused devices, including neural monitoring systems for children with epilepsy and implantable glucose monitors for pediatric diabetes management. These devices underscore the growing regulatory and industry recognition that pediatric patients are not just “small adults,” but require distinct technological approaches.
As companies like ENvue continue to expand their portfolios with pediatric-specific solutions, experts anticipate a faster trajectory toward safer, more effective interventions for children—especially in high-risk or high-frequency procedures like feeding tube placement.