Dallen Medical Inc., has gained U.S. FDA clearance for its Tensyn™ Band for acromioclavicular joint and coracoacromial ligament repair in shoulder separation.
Regulatory
FDA Approval for St. Jude’s TactiCath Quartz Contact Force Ablation Catheter for AF
TactiCath Quartz contact-force technology provides physicians with more control of contact force during ablation procedures in order to create more effective lesions in paroxysmal AF treatment.
FDA Clearance of ReFlow Medical Wingman35 Crossing Catheter
ReFlow Medical, Inc. has gained FDA clearance for its Wingman35 Crossing Catheter for use in the peripheral vasculature as well as the first U.S. clinical cases with the device.
CE Mark and First Implant of Sorin’s MEMO 3D ReChord™
Sorin Group has gained CE mark certification for its new MEMO 3D ReChord™ mitral valve annuloplasty ring, which it is making immediately available in Europe.
Remote Continuous Glucose Monitoring a Reality Following FDA Nod
FDA approval now means critical glucose data from the Dexcom G4® PLATINUM Continuous Glucose Monitoring System can be remotely monitored using a mobile device
CE Mark for Boston’s Pacemaker Opens MRI Conditionality Options
When implanted with Boston Scientific’s INGEVITY™ leads, Boston Scientific’s ACCOLADE pacemakers are the first to enable patients to receive full-body MRI scans in both 1.5 Tesla and 3.0 Tesla systems.
FDA Green Light for Vesiflo’s inFlow™ Female Urinary Catheter Alternative
Vesiflo, Inc., has seen its inFlow™ Urinary Prosthesis granted the U.S. FDA approval under Direct De Novo Petitioning rules.
Pacing Lead Approval for MR-Conditional Use in Bradycardia Patients
The U.S. FDA has approved Medtronic’s CapSureFix Novus™ MRI SureScan® 5076 Lead for use with magnetic resonance imaging.
Sedasys® System Sees U.S. Launch and Use During Routine Colonoscopy and EGD
The Sedasys minimal-to-moderate sedation system is up and running in healthy U.S. patients undergoing routine colonoscopy and esophagogastroduodenoscopy.
Bard Claims First and Only FDA-Approved Drug Coated PTA Balloon
The dream has become reality as Bard confirms approval of the Lutonix® 035 Drug Coated Balloon (DCB) Catheter for percutaneous transluminal angioplasty.
FDA Clears Covidien’s Nellcor™ Portable SpO2 Patient Monitoring System
Covidien’s newly cleared Nellcor™ Portable SpO2 Patient Monitoring System (PM10N) system is the only commercially available portable oximeter that is equipped with home care and sleep study modes.
Notified Body Orders Suspension of Endobarrier Shipments in Europe
GI Dynamics, Inc., developer of EndoBarrier® for treatment of obesity and type 2 diabetes, has seen its product suspended and announced falling sales.
Third Time Lucky as FDA Panel Votes Yes to WATCHMAN™ LAA Device
Expert Panel review has culminateded in a vote in favour of Boston Scientific Corporation’s WATCHMAN™ Left Atrial Appendage Closure Device.
CE Mark for Direct Flow Medical’s Enhanced Transfemoral TAVI Delivery System
Direct Flow Medical®, Inc., has received the CE Mark for an enhanced transfemoral delivery system for its Transcatheter Aortic Valve System.
510(k) Clearance Marks First Clinical Application for Philips New Digital Health Platform
Integrated healthcare has taken a step forward with the FDA clearance of the enabling technology that is Philips’ cloud-based telehealth platform
St. Jude Pacing Leads Now CE Marked as MRI Friendly
St. Jude Medical, Inc. has gained CE Mark approval that will allow patients fitted with its Tendril™ STS and IsoFlex™ Optim™ pacing leads, to undergo MRI scans.