People’s Daily Online, Beijing, February 28 (Reporter Sun Hongli) According to the official website of the State Food and Drug Administration, the State Food and Drug Administration has recently reviewed and approved the application for the registration of innovative products of the “Digestive Tract Vibrating Capsule System”. This product consists of a disposable digestive tract vibration capsule (referred to as capsule), a configurator and VCP software (VCP2.1), which is suitable for the symptomatic relief of functional chronic transit constipation in adults with poor drug treatment effect. Use under the guidance of a qualified physician.
It is reported that although there are various methods for constipation treatment, there are high prevalence, treatment side effects, high recurrence rate and low patient satisfaction. This product is expected to improve the quality of life of the applicable population.
The State Food and Drug Administration stated that this product stimulates the colon wall through vibration and promotes colonic peristalsis, providing a new treatment method for adults with functional chronic transit constipation whose drug treatment effect is not good. This product is the first of its kind, and there is no similar product listed at home or abroad at present. The innovation of this product is that the capsule has acceleration detection capability, which can be activated by monitoring the change of the acceleration value; the second is that the product belongs to non-drug treatment and can be used as another treatment plan for functional constipation.
The drug supervision and administration department will strengthen the post-market supervision of the product to protect the safety of patients using the device.