First-ever data at ACC.17 confirms safety and efficacy of new self-expanding, recapturable heart valve at 30-days with high survival, low stroke and minimal paravalvular leak
Approval/Clearance
FDA Clears PEEK Polymer CAD/CAM Dental Device for Long-Term Implant Borne Prosthetics
High performance polymer dental prosthetic device can potentially enable improved patient quality of life and efficiencies compared to metal
FDA Clears Medtronic’s Reveal LINQ™ Insertable Cardiac Monitor (ICM) with TruRhythm™ Detection
New system offers continuous wireless heartbeat monitoring for up to three years
FDA Nod for Altus Spine’s Cervical Plate System
Clearance for Fuji Cervical Plate for anterior interbody fixation
FDA Clearance for Medtronic CardioInsight™ Mapping Vest
System “makes it easy for patients to receive precise mapping results from their providers right at their bedside”
FDA Approval for First Balloon Expandable Stent Graft for Use in the Iliac Artery
GORE® VIABAHN® VBX becomes the only device of its type to gain indication
U.S. FDA Approval for Abbott Assurity MRI™ Pacemaker
From the recently acquired St. Jude stable, now in Abbott’s hands, Assurity now lays claim to being the World’s smallest, longest-lasting wireless MRI-compatible pacemaker
Chinese FDA Nod for ZipLine® Medical’s Non-Invasive ZIP® Skin Closure System
Clearance will give the company access to the $543 million Chinese wound closure device market serving over 40 million procedures
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
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