CE Mark of the Ablative Solutions Peregrine System™ Infusion Catheter signals continued interest in renal denervation therapy
Regulatory
EU Nod for St. Jude’s ICD MRI-Compatibility Claim
MRI-conditionality is rapidly becoming industry standard, at least in St. Jude’s range, as more ICD products are approved to make this claim in Europe
Australian Approval for GORE® EXCLUDER Iliac Branch Endoprosthesis
Gore’s newly approved device builds on its Excluder family of AAA treatment devices and is the first dedicated for use in the common iliac artery
FDA Approval and CE Mark for Medtronic’s Arctic Front Advance® ST Cryoballoon
Based on clinician feedback Medtronic’s third generation cryoballoon nudges ablative treatment of atrial fibrillation along
FDA Green Light for StimGuard’s IDE Study into Implantable Overactive Bladder Device
Could StimGuard’s tiny implant ultimately eliminate expensive pulse generators?
Another Spinal Cord Stimulation System Gets Pain Indication
Nevro Corporation has received approval from the U.S. FDA for its Senza spinal cord stimulation (SCS) system for the treatment of chronic pain.
FDA Cleared for U.S. Launch: Medtronic’s Euphora™ Semicompliant Coronary Balloon
Following on the heels of its non compliant forebear, the Euphora semicompliant coronary balloon offers enhanced pushability
Early CE Mark for STENTYS’ Next-Generation Self-Apposing Stent System
“Quantum Leap” in design means Self-Apposing stent delivery now mimics conventional stent placement, says the company
CE Mark for BONESUPPORT CERAMENT™|V, Injectable Vancomycin-Eluting Bone Substitute
First Injectable Vancomycin Eluting Bone Substitute in the Management of Osteomyelitis gains regulatory approval in Europe
First-of-its-Kind Approval for Near Vision Corneal Implant
The U.S. FDA has approved the first implantable device for correction of near vision in patients who have not had cataract surgery
U.S. FDA Clearance for Two Pigmented Lesion Treatments
Two new clearances have been announced for technologies to treat a variety of aesthetic treatments
FDA Approval for Only ICD to Deliver Ultra-High Energy on First Shock
Delivering 42 Joules on first shock addresses patients with high defibrillation thresholds
FDA Clears Conventus PH Cage™, MIS Proximal Humerus Fracture Solution
Industry’s first alternative to traditional treatment offers simpler procedure for proximal humeral fractures
Paradise Returns as ReCor Brings in Funding for New RDN Study
ReCor Medical has announced Series D investment of approximately $15M, which will position it to start a clinical study into its ultrasound-based renal denervation system
Direct Flow Trial Broadened to Include High Risk Patients and CoreValve® Comparison
FDA’s agreement to trial expansion should tell us whether novel valve design proves itself in competitive setting
FDA Clears Perseon’s MicroThermX® for Laparoscopic Cancer Ablation Procedures
MicroThermX® Microwave Ablation System cleared for laparoscopic ablation procedures using image guidance