The Intellihab system is intended to cure the pain brought on by crippling osteoarthritis market of the knee.
The US Food and Drug Administration (FDA) has granted CyMedica Orthopedics' Intellihab system approval as a non-invasive method of treating knee osteoarthritis pain.
The painful osteoarthritis disease's related pain can be treated using the home-based therapeutic and digital health environment.
Positive results from a randomised, sham-controlled, double-blind, multi-center clinical study served as the foundation for the FDA 510(k) approval.
IntelliHab significantly reduced pain and increased mobility for individuals with knee osteoarthritis, according to this study's evaluation of its safety and effectiveness. CyMedica will be able to further concentrate on evidence-based medicine and its commitment to assisting patients in managing osteoarthritis symptoms now that it has received regulatory approval.
"CyMedica recognizes the current standard of care for addressing knee osteoarthritis pain presents a substantial gap in accessible treatment alternatives," said Rob Morocco, president and chief executive officer of CyMedica Orthopedics.
"With IntelliHab's regulatory certification, we can offer a bridge between conservative therapy and more intrusive treatment alternatives, allowing patients to relieve their pain comfortably at home while decreasing narcotic exposure," says the company.
The device is advertised as the first neuromodulation strengthening therapy that the FDA has approved for individuals with osteoarthritis of the knee. Utilizing an easy-to-use, app-driven interface, it offers tailored muscle stimulation to lessen muscular weakness and keeps patients engaged during therapy.
Patients may interact with healthcare practitioners and provide vital information through a secure portal using the IntelliHab app.
It also enables healthcare professionals to remotely monitor patient usage and give real-time encouragement.
This autumn, CyMedica intends to commercialize the IntelliHab system in the US as a therapy for knee osteoarthritis.
To gain more information on the osteoarthritis market forecast, download a free report sample
read more..