Regulatory approval first Sono-Coat™ product
In July 2020 our undisclosed top-10 MedTech customer obtained FDA approval for a MW ablation needle with a Sono-Coat™ tip. This regulatory approval is the result of an effective partnership and a successful joint effort to integrate two novel technologies.
FDA approval marks an important commercial and clinical milestone in the development of the Sono-Coat™ technology. The first medical device with a Sono-Coat™ tip used is now ready for launch, fulfilling Encapson’s mission to improve patient care through innovative visibility solutions.
The regulatory dossier in Europe has been submitted, review has been completed and CE-Mark is pending
Note for the Press
Encapson has developed Sono-Coat™; an innovative echogenic coating system to improve the ultrasound visibility of medical devices in the body. The Sono-Coat™ technology is based on a coating matrix containing acoustically reflective microspheres. The microspheres scatter the ultrasound waves in all directions. The enhanced reflection leads to crystal clear and sharp images on the ultrasound screen. The Sono-Coat™ technology platform consists of two coating systems: the M-series for needles and the P-Series for catheters.
Sono-Coat™ enables precise targeting of objects in deeper tissue structures such as liver and kidney biopsies, facilitates vascular access, setting peripheral nerve block and tip confirmation of CVC, PICC, Drainage and Regional Anaesthesia catheters. The unmatched ultrasound visibility of Sono-Coat™ supports the physician in performing accurate, safe and error-free ultrasound-guided procedures.
Encapson provides coating services to the medtech industry. We develop advanced visibility solutions for a large variety of products creating unique value for your portfolio. Our company is ISO-13485:2016 certified and delivers high-quality products that meet stringent regulatory and end-user requirements.
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