Rampart One brings anatomy-conserving design to ALIF, says Spineology
Approval/Clearance
FDA Clearance and Launch of OrbusNeich Coronary Dilatation Catheters
Announcement marks company’s official entry into the US market
FDA Approval For Ethicon’s SURGICEL® Powder Absorbable Hemostat
Surgicel Powder targets control of continuous oozing on broad or raw surfaces
FDA Clears Claret Medical’s Sentinel Cerebral Protection System
First and only embolic protection device shown to reduce TAVR procedural strokes by 63 Percent
Indian Approval Opens up $3.5billion Market for Zip® Wound Closure System
And new clinical study demonstrates higher tissue perfusion than staple closure in Total Ankle Replacement Surgery
Abbott Says Newly CE Marked Confirm Rx™ ICM Represents New Paradigm
Device automatically captures vital cardiac information and relays data to physicians via smartphone app, enabling remote monitoring of irregular hearth rhythms
FDA Clears Teleflex Arrow® AC3 Optimus™ Intra-Aortic Balloon Pump
Teleflex claims advanced IABP performance with the ability to provide optimized therapy to the most challenging patient conditions
Samsung Launches New Ultrasound Systems
Designed to enhance the user experience, Samsung’s HS50 and HS60 bring the image quality and advanced technologies from their high-end systems to a mid-range price point, says company
FDA Nod for Paxman’s Scalp Cooler
Company to offer patients novel pay-as-you-go scheme as it aims to revolutionize U.S. scalp-cooling landscape
U.S. FDA Clearance For UOC’s Polyethylene Knee Insert
Knee insert is designed to provide patients with knee replacements with reduced risk of oxidation
CE Mark for REVA’s Fantom Drug-Eluting Bioresorbable Stent
European launch of Fantom coronary stent underway
FDA Clearance for “Procedure in a Box” Uni Knee System
Bodycad receives FDA 510K clearance for personalized unicompartmental knee system
FDA Approves Medtronic CoreValve™ Evolut™ Pro Transcatheter Valve
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
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