Digital health and well-being app developer Paindrainer AB announced on Thursday that its Paindrainer PD1 app has received U.S. Food and Drug Administration (FDA) registration approval as a Medical Device Class 1 (510k exemption), marking it as the first such tool for chronic pain.

The FDA's low risk classification aligns with the recent US multi-center trial's risk-free findings.

Paindrainer AB specializes in health-focused digital solutions. The Paindrainer app, driven by advanced algorithms, is the first evidence-based digital tool enhancing chronic pain patients' quality of life through 360° patient-centricity.

Pain Medicine published a notable clinical study, highlighting Paindrainer's 12-week program's significant enhancements in pain management, physical function, mental well-being, and pain perception.