A first patient has been treated in the EVAS2 IDE Confirmatory Clinical Study of the Nellix® EndoVascular Aneurysm Sealing system.
Regulatory
FDA Clears Expanded Indication of Acclarent AERA® Eustachian Tube Balloon Dilation System
Procedures may now be performed on patients as young as 18. New data on local anesthesia also recognized
Strong U.S. Sales Growth for joimax®: Now Company Launches MultiZYTE® Facet and SI Joint Treatment Set
joimax has also obtained full approval of its Endovapor® 2 system in China
Endologix Completes ELEVATE IDE Clinical Study Enrollment
Endovascular stent graft study promises clinical results later this year
FDA Nod for CardiAmp Cell Therapy IDE Trial in Chronic Myocardial Ischemia
“It is a step towards developing a new treatment strategy that could have tremendous benefit for patients with refractory angina”
LimFlow US Feasibility Study Completes Enrollment
FDA allows study expansion and grants system “Breakthrough Device” status
PMA Submitted for Pulmonx® Zephyr® Endobronchial Valve for Emphysema
Already available around the world, Pulmonx hopes to get FDA nod for U.S. patients
First Patient Enrolled in U.S. LAA Stroke Study
Biosense Webster, Inc. launches U.S. study to evaluate the safety and efficacy of the WaveCrest® Left Atrial Appendage Occlusion System
Spirosure’s Fenom PRO™ Point-of-Care Breathalyzer 510(k) Submission
Portable analyzer helps patients manage their asthma by measuring nitric oxide (NO) in their exhaled breath, a biomarker foreshadowing airway obstruction
Invibio Aims to Accelerate Time-to-Market for Innovative Medical Devices
Company investing in plans to streamline device development
FDA Clearance for MedShape DynaNail XL
New 260mm and 300mm offerings expand indications for NiTiNOL-based TTC Fusion device
Radar Breast Tumor Localization Gets FDA Clearance for Long Term Implant
Cianna Medical’s SCOUT system uses highly sophisticated radar technology for unprecedented precision
Abbott’s MitraClip First Transcatheter Mitral Valve Repair Device Approved in Japan
Japanese study data underpins approval
Maetrics Global Life Sciences Consultancy Talks MDR at Medica
Company will present original research whitepaper on importance of speedy MDR compliance
New Software Connects Device Companies’ Entire Quality “Ecosystem”
“Being able to easily link and connect nonconformances, complaints, audit findings, CAPAs and documents will greatly improve our internal efficiency and compliance…”
FDA Clears Stryker Cementless Mako Total Knee with Triathlon® Tritanium®
Stryker aims to strengthen its leadership position in robotic technology