Clearance will give the company access to the $543 million Chinese wound closure device market serving over 40 million procedures
Regulatory
CE Mark for World’s First Sterile, Single-Use Endoscope for Colonoscopies
The invendoscope™ SC200 effectively means a personal endoscope for each patient
CE Mark for Percutaneous CLI System
“No option” Critical Limb Ischemia Patients may soon have an option as clever, ultrasound-guided revascularisation technology gains EU nod
New Registry Data Revives EndoBarrier Hopes
Over a year since the discontinuation of its US study, GI Dynamics, Inc., says it has demonstrated clinical benefit in a German registry.
FDA Approves St. Jude Medical BurstDR™ Spinal Cord Stimulation for Chronic Pain
BurstDR stimulation targets chronic pain patients with a new therapy option designed to provide less pain, less suffering and less therapy maintenance
CE Mark for World’s Lowest Profile Single-Port Surgery Solution
Fortimedix Surgical has received CE Mark approval for FMX314, the world’s first single-port surgery solution that is compatible with a standard 15mm trocar
FDA Clearance of the invendoscopy E200 System Including the First and Only Sterile, Single-use Endoscope For Colonoscopies
invendo Medical says its system is a simple, safe and effective solution to the challenges of cross-contamination and infection control
FDA Clearance of Centric Medical™ TARSA-LINK™ Bunion System
Centric Medical has announced the U.S. FDA 510(k) clearance of its TARSA-LINK Bunion Correction System, which utilizes a PEEK polymer implant
U.S. FDA Approval for Boston Scientific’s EMBLEM™ MRI S-ICD System
Approval grants MR-conditional labeling to all EMBLEM S-ICD Systems, further expanding the company’s ImageReady™ portfolio
CE Mark for Spectranetics AngioSculptX Drug-coated ‘Scoring’ Balloon
Novel balloon catheter with nitinol “scoring” element gains CE mark
CE Mark for Lower Extremity Compresssion Device
U.S company, FlowAid Medical Technologies Corp., has received CE mark approval for its FA100 SCCD Sequential Contraction Compression Device.
Palliative Spine Surgery Options Increased with First-Ever FDA Clearance for Cement-Augmented Pedicle Screws
Clearance of Medtronic’s CD Horizon® Fenestrated Screw Set gives spine surgeons a new treatment option for spinal tumors patients
FDA Approval for Medtronic’s Two-Level Prestige LP™ Cervical Disc System
Prestige LP™ Cervical Disc approved for the treatment of cervical disc disease causing nerve or spinal cord compression at two adjacent levels between the C3-C7 segments
First US Cases for MIS Nasal Valve Collapse Device
Newly cleared minimally invasive device for lateral cartilage support in patients with nasal valve collapse, a major cause of nasal obstruction
FDA Approves St. Jude Medical’s New CRT Software for Managing Heart Failure Patients
St. Jude Medical, Inc., has achieved U.S. FDA approval and announced the launch of its SyncAV™ CRT software which it says will enhance its already comprehensive cardiac resynchronization therapy portfolio.
Medtronic’s NuVent™ Indications Expanded to Include Revision Sinus Surgery
Clinical study conducted on revision subjects supports expanded indication for patients with previously surgically altered tissue