The PainQx platform system is currently an investigation medical device. The PainQx platform will be seeking FDA Clearance as a Class II medical device in 2020.
The PainQx platform upon FDA Clearance will address the issues illustrated below by providing:
- Objective Pain Measurement: Improving patient outcomes
- Patient Pain State Confirmation: Empowering practitioner’s clinical decisions
- Effective Pain Management: Addresses under / over treatment dilemma
Assessing A Patient’s Pain State with PainQx:
Patients’ brain waves are analyzed and PainQx generates a Pain Classification for the patient. Current classification categories include no pain, mild to moderate pain, and severe pain. The pain categories have been chosen to correspond to different pain treatment protocols such as physical therapy, surgery, over the counter NSAIDS, prescription opioids, etc. PainQx is working to provide additional granularity in the pain categories. The PainQx pain classification is intended to be used as adjunctive information. Once the patient examination is completed, the physician makes a treatment decision based on the patient’s PainQx pain classification, medical history, patient presentation/symptoms, and the self-reported NRS pain score.
The presence of a quantifiable and objective tool that provides information on a patient’s pain state reduces a physician’s liability during disputes as independent, objective information can be included in the discussion
Advantages of PainQx Methodology:
The PainQx system is a quantifiable and objective assessment tool that the doctor can use to establish an initial patient pain state and assess changes in pain classification as part of subsequent visits.
- Reduces reliance on the subjective, patient provided pain score
- Removes sociological influences inherent in collecting subjective, verbal information from the patient regarding their level of pain
- Provides a physiologically based assessment, reducing variability associated with subjective reporting
Advantages of the PainQx Platform include:
- A reliable, objective assessment across visits reduces uncertainty of treatment leading to improved clinical outcomes and savings to the healthcare system
- Improved dosing leads to fewer incidence of opioid abuse thereby reducing the risk of addiction or drug diversion
- Improved dosing leads to a reduction in under-treatment, improving patient satisfaction