Friday, August 11, 2023
Paindrainer AB is delighted to announce a significant achievement: its revolutionary 360° patient-centric© app, Paindrainer® PD1, has received official registration approval as a Medical Device Class 1 (510k exemption) from the U.S. Food and Drug Administration (FDA). This milestone solidifies Paindrainer® PD1 as the pioneering self-management tool for chronic pain to secure FDA approval as a Low Risk Medical Device Class 1.
The classification of Paindrainer® PD1 as a Medical Device Class 1 aptly aligns with its categorization as a low-risk solution. This categorization is reinforced by the absence of observed risks noted in a recent multi-center trial conducted in the United States.
Erik Frick, CEO of Paindrainer AB, conveyed his enthusiasm about this accomplishment, remarking, "We're extremely pleased to share the news that Paindrainer® PD1 has garnered FDA approval as a Low Risk Medical Device Class 1 in the United States. This achievement perfectly aligns with our strategic roadmap for the commercialization and global expansion of Paindrainer®."
Paindrainer AB specializes in developing digital platforms and applications that contribute to health and well-being. Powered by innovative algorithms, the Paindrainer® app is the first evidence-based digital tool demonstrating enhanced quality of life for patients grappling with chronic pain. The app's hallmark is its adaptability to each patient's unique requirements, a concept referred to as 360° patient-centricity©.
A recent clinical multi-center study of Paindrainer®, published in the esteemed journal Pain Medicine, showcased notable advancements in areas such as pain interference, physical function, depression, anxiety, and pain catastrophizing over a 12-week study period.
As Paindrainer AB readies itself for the commercial debut of the app in the United States, the company remains steadfast in its commitment to elevating healthcare accessibility and efficiency. The innovative approach encapsulated in Paindrainer® PD1 holds the promise of revolutionizing the management of chronic pain and ultimately leading to improved outcomes for patients. Erik Frick concluded by emphasizing, "Our innovative approach has the potential to revolutionize chronic pain management and pave the way for better patient outcomes."