Pain relief using implantable neurostimulation has come on a lot in recent times. For evidence, try searching our pages. Now … continue reading “Pain Relief Boost with Spinal Cord Stimulator Approval”
Companies
U.S. FDA Approves Pipeline™ Flex Embolization Device with Shield Technology™
Medtronic plc has received U.S. FDA approval for Pipeline™ Flex Embolization Device with Shield Technology™. Background An estimated 500,000 people throughout the … continue reading “U.S. FDA Approves Pipeline™ Flex Embolization Device with Shield Technology™”
FDA Approves Expanded Labeling of Medtronic MRI Leads
Medtronic plc says it has received approval from the U.S. FDA for expanded MRI labeling of its InterStim™ II and InterStim™ … continue reading “FDA Approves Expanded Labeling of Medtronic MRI Leads”
FDA Clearances Enhance Mazor™ Robotic Guidance System
The U.S. FDA has cleared the use of navigated interbody and Midas Rex™ high speed drills with the Mazor™ Robotic Guidance System earlier than originally anticipated
FDA OKs ReCor Paradise™ Ultrasound Renal Denervation
ReCor Medical’s Paradise™ Ultrasound Renal Denervation System has received Breakthrough Device Designation from the U.S. FDA for the treatment of patients with uncontrolled hypertension who are inadequately responsive to anti-hypertensive medications.
Carpediem™ First Cardio-Renal Pediatric Dialysis Launch
Medtronic plc has announced the U.S. commercial launch of the Carpediem™ Cardio-Renal Pediatric Dialysis Emergency Machine, the first and only … continue reading “Carpediem™ First Cardio-Renal Pediatric Dialysis Launch”
U.S. Launch for Boston Scientific SpaceOAR Vue™ Hydrogel
Next-generation Hydrogel spacer offers enhanced visibility via CT Scan to optimize treatment planning for patients undergoing radiation for prostate cancer. … continue reading “U.S. Launch for Boston Scientific SpaceOAR Vue™ Hydrogel”
Medtronic’s ENT Portfolio Grows with FDA Clearance of NIM Vital and Acquisition of Ai Biomed
Medtronic plc, has received U.S. FDA 510(k) clearance of the NIM Vital™ nerve monitoring system, which enables physicians to identify, … continue reading “Medtronic’s ENT Portfolio Grows with FDA Clearance of NIM Vital and Acquisition of Ai Biomed”
Medtronic DTM™ Spinal Cord Stimulation Therapy Outperforms Conventional SCS Therapy for Back Pain Relief at 12 Months
Statistically significant 12-month results from a large, multicenter randomized controlled trial confirm 84% Back Pain Responder Rate and 69% Profound … continue reading “Medtronic DTM™ Spinal Cord Stimulation Therapy Outperforms Conventional SCS Therapy for Back Pain Relief at 12 Months”
First Patients in Europe Treated with Biosense Webster VARIPULSE® AF Catheter
Johnson & Johnson Medical Devices Companies’ Biosense Webster, Inc., says the first patients have been enrolled and treated in its … continue reading “First Patients in Europe Treated with Biosense Webster VARIPULSE® AF Catheter”
FDA Approval for Biosense Webster THERMOCOOL SMARTTOUCH® SF Ablation Catheter for Persistent Atrial Fibrillation
Johnson & Johnson Medical Devices Companies have announced the U.S. FDA approval of Biosense Webster, Inc.’s THERMOCOOL SMARTTOUCH® SF Ablation … continue reading “FDA Approval for Biosense Webster THERMOCOOL SMARTTOUCH® SF Ablation Catheter for Persistent Atrial Fibrillation”
Medtronic Launches Adaptix™ Interbody System, First Navigated Titanium Cage with Titan nanoLOCK™ Surface Technology
Medtronic plc, has chosen the North American Spine Society (NASS) annual meeting at which to announce the U.S. launch of … continue reading “Medtronic Launches Adaptix™ Interbody System, First Navigated Titanium Cage with Titan nanoLOCK™ Surface Technology”
Two New FDA-Approved Bladder and Bowel Control Therapies
Medtronic plc, has received approval from the US FDA for its InterStim™ Micro neurostimulator and InterStim™ SureScan™ MRI leads. Background … continue reading “Two New FDA-Approved Bladder and Bowel Control Therapies”
Rezūm™ Water Vapor BPH Therapy Effective After Five Years
New clinical study results say the Rezūm System provided significant, sustained improvement of lower urinary tract symptoms (LUTS) and quality of … continue reading “Rezūm™ Water Vapor BPH Therapy Effective After Five Years”
CE Mark for “World First” Single-Use Duodenoscope, EXALT Model D
Boston Scientific Corporation has gained the CE Mark and initiated a limited market release of the EXALT™ Model D Single-Use (disposable) … continue reading “CE Mark for “World First” Single-Use Duodenoscope, EXALT Model D”
Newly Cleared Cranial Robotic System Sees First Paediatric Deployment
Phoenix Children’s Hospital, is the first health system in the U.S. to receive and deploy the newly FDA-cleared Medtronic Stealth … continue reading “Newly Cleared Cranial Robotic System Sees First Paediatric Deployment”