Incubated device company Kator has gained FDA 510(k) clearance for its suture anchor system that claims to outperform some of the market leaders.
Regulatory
CE Mark for Medtronic’s New ICDs that can Detect Atrial Fibrillation
Medtronic’s new ICDs enable physicians to manage patients at increased risk for stroke and heart failure
Another NASS Launch: K2M’s 3D Printed Interbody Systems
CASCADIA AN & TL Interbody Systems featuring K2M’s New Technology are Cleared for Market and Launched at NASS
FDA Clears First Surface Porous PEEK Interbody Fusion Device
Vertera Spine’s COHERE device will be unveiled at the upcoming NASS meeting
New Drug-Coating Technology Gets Green Light for Balloon Trial
SurModics receives FDA IDE approval for early feasibility study of the SurVeil™ drug-coated balloon
FDA Approves “Try Before You Buy” Incontinence Therapy Evaluation System
Discreet, wireless touchscreen system allows for shorter evaluation of potential for long-term restoration of bladder or bowel function
greenlight.guru Pitches New Medical Device Risk Management Software
greenlight.guru announces the release of its new cloud-based Risk Management Software exclusively for medical device companies to help reduce risk and ensure compliance
New FDA Clearance Means Implanet’s JAZZ Band™ Expands Indication for Use with Other Posterior Fixation Systems
Surgeons will now be able to use JAZZ Band in conjunction with their spinal fixation system of choice
St. Jude Medical Gains CE Mark for 27mm & 29mm Portico TAVR Valves
The latest approval increases patient access to St. Jude’s TAVR implant that provides excellent patient outcomes and the opportunity to optimize device placement
Cook’s Zenith Alpha™ Thoracic Endovascular Graft Gains FDA Approval
Cook claims its Thoracic Endograft will allow physicians to treat more patients with TEVAR
FDA Approval for Precision Spine’s Reform® Modular and HA Coated Pedicle Screw Systems
Modular system is designed to help increase the bone/screw interface to enhance pull-out strength and allow for efficient screw delivery.
Direct Flow Medical® Adds Experience to Regulatory and Clinical Affairs
As it strives to gain U.S. approval, this most innovative of transcatheter heart valve developers has enlisted the services of an industry regulatory veteran
Only MR-Conditional Rechargeable Spinal Cord Stimulator With Burst Stimulation Gets CE Mark
St. Jude has gained CE mark approval for its Prodigy MRI™ spinal cord stimulation therapy, the first of its kind to offer MRI compatibility and Burst stimulation
FDA 510(k) Clearance for Zyga SImmetry® Sacroiliac Joint Fusion System Updates
New clearance extends system’s indications to include new MIS approaches for Sacroiliac Joint fusion
Enrollment Complete in HeartWare’s Endurance2 HVAD Trial
Device aims to be indicated as a destination therapy rather than as a bridge to transplantation
Packaging Particulates Provoke Recall of Medtronic TAVI Loading System
Particulate matter in the delivery system of Medtronic’s newly FDA approved CoreValve Evolut R system present enough risk to warrant and FDA Class 1 Recall