PharmaSens AG, a Swiss company dedicated to improving access to insulin pump therapy, has successfully submitted its FDA approval application for the revolutionary "niia essential" insulin pump system. This achievement comes on the heels of the company obtaining ISO 13485 certification, covering the entire process from insulin infusion pump and accessory design to manufacturing and distribution.

The "niia essential" system, the first in a series of three patch pumps, prioritizes a patient-centric design for enhanced simplicity and aims to address unmet needs in the diabetes management market. Marcel Both, CEO of PharmaSens, expressed, "Our submission to the FDA is a pivotal step toward making advanced diabetes care more accessible. We are dedicated to transforming the experience of diabetes management through our innovative technology." With a strong patent portfolio and an experienced team, PharmaSens is well-prepared to meet the stringent FDA requirements. The "niia essential" system stands out for its user-friendly interface, promising to improve the daily lives of diabetes patients worldwide.

PharmaSens' inaugural product, the niia essential Insulin Patch Pump System, is known for its streamlined design, combining the convenience of an insulin pen with the sophistication of an insulin pump. Notable features include the innovative 3ml reservoir, offering extended usage and access to reimbursed patch pump therapy, positioning niia essential as one of the most compact patch pumps available. The system also introduces a unique automatic needle insertion mechanism, safeguarding the 90° steel needle before each use. Furthermore, the environmentally conscious semi-reusable concept aligns with principles of cost-efficiency and sustainable product design.

Source: pharmasens.com

 

 

 

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