Device automatically captures vital cardiac information and relays data to physicians via smartphone app, enabling remote monitoring of irregular hearth rhythms
Regulatory
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
Randomized Scalp Cooling Trial Shows Alopecia Reduction in Early Stage Breast Cancer Chemo Patients
Results published in leading peer-reviewed US oncology journal
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
First Patient for C-Scan® Colorectal Cancer Screening System Trial
Preparation-free, capsule-based technology has potential to improve colorectal cancer screening rates