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On June 9, 2021, CyMedica Orthopedics announced that the US FDA has approved a regulatory application for its IntelliHab system to relieve knee osteoarthritis (knee osteoarthritis) pain
.
The IntelliHab system is a treatment and digital health ecosystem used at home.
Symptomatic knee osteoarthritis, also known as degenerative joint disease, not only affects the health and mobility of tens of millions of patients, but related medical expenses may cause a huge social and economic burden in the future
.
More than half of the patients are younger than 65 years old and may be affected by the disease for decades after diagnosis
The IntelliHab system relies on neuromuscular electrical stimulation therapy
.
That is, electrical impulses are directly transmitted to the motor nerves that innervate the quadriceps of the patient, so that the muscles contract in the same way as in squatting or other exercises
The FDA's 501(K) approval is based on the positive results of a randomized, double-blind, multi-center clinical trial
.
The trial aims to evaluate the efficacy and safety of IntelliHab in patients with knee osteoarthritis
Note: The original text has been deleted
Reference materials:
[1] CyMedica Orthopedics Announces FDA Clearance for IntelliHab™, a Novel Drug-free, Non-invasive Modality for Treatment of Knee Osteoarthritis Pain.
Retrieved June 9, 2021, from https:// cymedica-orthopedics-announces-fda-clearance-for-intellihab-a-novel-drug-free-non-invasive-modality-for-treatment-of-knee-osteoarthritis-pain-301308495.
html
[2] FDA clears CyMedica's app-connected muscle stimulation system to treat osteoarthritic knee pain.
Retrieved June 9, 2021, from https:// -stimulation-system-to-treat-osteoarthritic-knee
On June 9, 2021, CyMedica Orthopedics announced that the US FDA has approved a regulatory application for its IntelliHab system to relieve knee osteoarthritis (knee osteoarthritis) pain
.
The IntelliHab system is a treatment and digital health ecosystem used at home.
It introduces a non-opioid non-invasive treatment option for patients seeking to relieve knee osteoarthritis pain, while being able to remotely provide real-time progress data to doctors
Symptomatic knee osteoarthritis, also known as degenerative joint disease, not only affects the health and mobility of tens of millions of patients, but related medical expenses may cause a huge social and economic burden in the future
.
More than half of the patients are younger than 65 years old and may be affected by the disease for decades after diagnosis
The IntelliHab system relies on neuromuscular electrical stimulation therapy
.
That is, electrical impulses are directly transmitted to the motor nerves that innervate the quadriceps of the patient, so that the muscles contract in the same way as in squatting or other exercises
The FDA's 501(K) approval is based on the positive results of a randomized, double-blind, multi-center clinical trial
.
The trial aims to evaluate the efficacy and safety of IntelliHab in patients with knee osteoarthritis
.
The results of the test showed that the patient’s knee pain was significantly reduced and his mobility improved
.
(WuXi AppTec)
Note: The original text has been deleted
Reference materials:
[1] CyMedica Orthopedics Announces FDA Clearance for IntelliHab™, a Novel Drug-free, Non-invasive Modality for Treatment of Knee Osteoarthritis Pain.
Retrieved June 9, 2021, from https:// cymedica-orthopedics-announces-fda-clearance-for-intellihab-a-novel-drug-free-non-invasive-modality-for-treatment-of-knee-osteoarthritis-pain-301308495.
html
[2] FDA clears CyMedica's app-connected muscle stimulation system to treat osteoarthritic knee pain.
Retrieved June 9, 2021, from https:// -stimulation-system-to-treat-osteoarthritic-knee
