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.
Products
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.
da Vinci Clearance is “Last Piece of the Puzzle” for Single-Site hysterectomy
Robot surgery company Intuitive Surgical, Inc. has received U.S. FDA clearance for its Single-Site Wristed Needle Driver for use in single-incision surgery.
CE Mark and First Use of ReFlow Medical Endovascular Catheters
Cardiovascular device specialist ReFlow Medical Inc. has gained CE mark approval for its Wingman35 Crossing Catheter and speX™ Shapeable Support Catheter.
DePuy Synthes Touts Variable Angle Locking Technology for Calcaneal Fractures
J&J’s DePuy Synthes has launched two new variable angle plating systems featuring its proprietary variable angle locking technology.
Covidien Expands US Sonicision™ Range Following FDA Clearance
Covidien plc says its Sonicision™ Cordless Ultrasonic Dissection Device portfolio extends to 13 cm, 26 cm, and 48 cm device lengths following U.S. FDA 510(k) clearance.
CE Mark for Non-Invasive Open Ventilation (NIOV) System
Breathe Technologies’ NIOV device has become the first and only wearable, ventilation system for people with respiratory insufficiency to receive a CE Mark.