Irish pharmaceutical company Allergan plc (NYSE:AGN) reported on Monday the receipt of clearance from the US FDA for the CoolTone device for improvement of abdominal tone, strengthening of the abdominal muscles, development for firmer abdomen as well as for strengthening, toning and firming of buttocks and thighs.
The CoolTone technology, which uses the magnetic muscle stimulation (MMS), penetrates into the muscle layers and induces involuntary muscle contractions. The body responds to these contractions by strengthening its muscle fibres, resulting in improved muscle conditioning. The CoolTone strengthens, tones and firms the muscles in the treated area. It has 50% more magnetic intensity than the leading competitor at the point of contact, said the company.
Following the US FDA clearance, the company is now taking orders for the CoolTone device and first units will ship early in the fourth quarter of this year.
According to the company, the CoolSculpting is a non-surgical, clinically proven treatment that selectively reduces unwanted fat using a patented cooling technology. Cleared by the US FDA, CoolSculpting works by gently cooling targeted fat cells in the body to induce a natural, controlled elimination of fat cells without affecting surrounding tissue and the treated fat cells are gone for good.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval