Medical device company Q'Apel Medical reported on Tuesday the receipt of US Food and Drug Administration clearance for its novel walrus Balloon Guide Catheter (BGC) for the neurovascular market.
The US FDA approved walrus BGC, with its 087 ID, marks a big step forward in balloon guide catheter technology and for stroke patients worldwide, added the company .
In conjunction, the walrus BGC represents the company's second US FDA-cleared technology in the past 12 months, joining the wahoo Access Catheter with Selectflex technology.
Additionally, the company expects to launch more innovative neurovascular products with speed, reliability and performance slated in the market over next year.
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