Surgical fixation company Via Surgical Ltd disclosed on Monday the receipt of the US Food and Drug Administration 510(k) clearance for the FasTouch Absorbable Fixation System for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures including hernia repairs.
Upon the US FDA approval, the FasTouch Absorbable is commercially available in the USA and will be exclusively distributed in this region by Progressive Medical Inc.
The company added that the FasTouch enables for the first time an automated lockable surgical mesh fixation that is strong and stable yet easily and consistently delivered.
In conjunction, the company's data clearly demonstrates that a lockable solution is more reliable in a dynamic environment and minimises the risk of tack migration or dislodgement that may lead to complications and hernia recurrences. The soft tissue tends to move, shift, contract and its products are designed to lock into the tissue, providing a closed loop, stable and reliable fixation.
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