Paindrainer AB´s digital tool is the first device targeting chronic pain to receive FDA registration approval as a Medical Device Class 1
MEDICON VILLAGE, LUND, SWEDEN – Paindrainer AB is pleased to announce that the company’s 360° patient-centric© app (Paindrainer® PD1) has received registration approval as a Medical Device Class 1 (510k exemption) by the U.S. Food and Drug Administration (FDA).
A Medical Device Class 1 falls under the low risk category according to the FDA classification system, which was also in line with the absent of risk observed in the most recent multi-center trial in the US.
"We are thrilled to share this significant achievement and milestone that the Paindrainer® App, as the first self-management tool for chronic pain, has received approval of registration as a Low Risk Medical Device Class 1 by the FDA in the United States. The positive announcement is completely in line with our pivotal commercialization strategy and globalization for Paindrainer®”, says Erik Frick CEO Paindrainer AB.
Paindrainer AB is a company developing digital platforms and applications contributing to health and well-being. The Paindrainer® app is the first evidence based digital tool demonstrating improved quality of life in patients suffering from chronic pain. The solution is powered by leveraging unique advanced algorithms and is fully adaptive to each patient, a feature we call 360 o patient-centricity©.
The well-respected Pain Medicine recently published Paindrainer’s clinical multi-center study showing significant improvements in subjects’ pain interference, physical function, depression, anxiety, and pain catastrophizing over the 12-week study period. *
As we prepare for the commercial launch in the United States, we remain committed to making healthcare more accessible and efficient. Our innovative approach promises to revolutionize the management of chronic pain and pave the way for improved patient outcomes.”, concludes Erik Frick.
* Link to the Abstract Pain Medicine: An artificial intelligence-powered, patient-centric digital tool for self-management of chronic pain: A prospective, multicenter clinical trial - PubMed (nih.gov)
For more information, please contact:
Erik Frick
VD Paindrainer AB
erik.frick@paindrainer.com
+46 736 612123
About Paindrainer AB
Paindrainer AB is a company developing digital platforms and applications contributing to health and well-being. Paindrainer was founded in 2018 by Prof. Carl Borrebaeck, Dr. Maria Rosén Klement, and Göran Barkfors (IT specialist). The idea was born when Maria, after participating in several pain rehabilitation programs, realized that the pain is affected by more factors than the human brain can keep track of, since all days are different.
The Paindrainer® App coaches the users in managing their pain and planning their day not to exceed a certain pain level, and to ensure that there is enough energy left for activities highly valued. The solution is powered by leveraging unique advanced algorithms and is fully adaptive to each patient, a feature called 360 o patient-centricity©.
The Paindrainer® App is the first evidence based digital tool demonstrating improved quality of life in patients suffering from chronic pain.
The Paindrainer® App (Paindrainer PD1) is an FDA registered Medical Device Class 1, MDR compliant and CE certified.