Encapson MedTech customer submits regulatory dossiers for Sono-Coat™ MW ablation needle
- Another milestone was reached in getting the first Sono-Coat™ product to market. In Q4 2019 and Q1 2020 one of Encapson key customers filed regulatory dossiers for CE marking and FDA approval of their Microwave Ablation needle. The CE dossier was submitted under the existing MDD regulation and CE approval is anticipated in May 2020. FDA approval is expected in Q3 2020
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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