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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
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
The IntelliHab system relies on neuromuscular electrical stimulation therapy
The FDA's 501(K) approval is based on the positive results of a randomized, double-blind, multi-center clinical trial
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.
[2] FDA clears CyMedica's app-connected muscle stimulation system to treat osteoarthritic knee pain.
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
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
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
.
These contractions can strengthen the muscles, thereby reducing the pressure on the patient's knees and achieving the effect of reducing pain
.
Patients can use the electrical stimulation system connected to the app to perform regular neuromuscular electrical stimulation at home, and manage and control their own muscle stimulation therapy through the app
.
In addition, their doctors can also remotely monitor their usage and disease progression
.
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