FDA Approved Archives - TMG Pulse

Nevro (NYSE:NVRO) announced today that it received FDA approval for its Senza system for treating chronic […]

article

FDA Approved MedTech Neuro

Medtronic bags FDA approval for Vanta implantable neurostimulator

Medtronic has received US Food and Drug Administration (FDA) approval for its Vanta device–a recharge-free […]

article

Diagnostics FDA Approved Oncology Pharmaceutical

Cardinal Health wins new FDA approval for Lymphoseek

Cardinal Health (NYSE:CAH) announced today that the FDA approved its Lymphoseek injection for pediatric use. […]

article

FDA Approved Implantables MedTech

FDA approves “first-of-its-kind” SenSight Directional Lead System for DBS therapy

Medtronic has announced US Food and Drug Administration (FDA) approval and first US implants of […]

article

FDA Approved Implantables Neuro

Medtronic gains FDA approval to trial implantable tibial neuromodulation device

Medtronic has announced approval from the US Food and Drug Administration (FDA) to proceed with […]

article

FDA Approved MedTech

FDA approves Medtronic Pipeline Flex with Shield Technology to treat brain aneurysms

Medtronic has received US Food and Drug Administration (FDA) approval for the Pipeline Flex embolization […]

article

FDA Approved Implantables MedTech Spine

NuVasive’s Simplify Disc gains FDA approval for use in two-level cTDR

NuVasive has gained FDA approval for its Simplify Cervical Artificial Disc, allowing the device to […]

article

Cardiology FDA Approved Surgery Vascular

Medtronic’s Harmony pulmonary valve wins FDA approval

Dive Brief: FDA on Friday said it approved Medtronic’s catheter-based treatment for pediatric and adult […]

article

FDA FDA Approved Spine

PMA submission process initiated for FDA approval of Limiflex

Empirical Spine, maker of the LimiFlex paraspinous tension band, has announced initiation of the PMA […]

article

FDA Approved MedTech Neuro

FDA approval brings remote programming for Abbott’s deep brain stimulation device

The digitization of implanted devices continues apace. On Monday, Abbott announced the launch of its […]

article

FDA Approved MedTech Neuro

FDA authorizes Q-Collar to help protect athletes’ brains

The FDA announced today that it authorized the Q-Collar made by Q30 Sports Science for […]

article

FDA Approved MedTech Orthopedic

FDA approves 3D-printed ankle implant for humanitarian use

Dive Brief: FDA has approved a 3D-printed medical device for humanitarian use in the treatment […]

article

Cardiology FDA Approved MedTech

Medtech Miniaturization: How Tiny Devices Make a Big Impact

Nearly five years ago, FDA approved Medtronic’s Micra, the first leadless pacemaker to reach the […]

article

FDA Approved MedTech Surgery

FDA Approves First Prosthetic Implant for Above-Knee Amputees

FDA approved the first implant system for adults who have above-the-knee amputations and might not […]

article

Drug-delivery FDA Approved MedTech

Vercise Genus DBS system received FDA approval 

Boston Scientific has announced that it has received US Food and Drug Administration (FDA) approval for […]

article

Cardiology FDA Approved MedTech

DiamondTemp Ablation System FDA Approved for AFib

Cardiac ablation is the current go-to method for treating most cases of atrial fibrillation (AFib) […]

article

FDA Approved MedTech Neuro

Vercise Genus Deep Brain Stimulation for Parkinson’s FDA Approved

Boston Scientific has landed FDA clearance for its Vercise Genus Deep Brain Stimulation (DBS) System. This […]

article

FDA Approved Patient Monitoring

How continuous glucose monitors have transformed the diabetes landscape

Continuous glucose monitors (CGMs) are among the most potent diabetes management tools to emerge in […]

article

FDA Approved MedTech Neuro

Medtronic-Axonics sacral neuromod patent battle heats up

Dive Brief: The U.S. Patent and Trademark Office’s Patent Trial and Appeal Board has decided […]

article

Drug-delivery FDA Approved Sensors

FDA approves Medtronic MiniMed 770G insulin pump for young children

The FDA has approved the Medtronic (NYSE:MDT) MiniMed 770G hybrid closed loop-diabetes management system for Type 1 […]

article

Cardiology FDA Approved Structural Heart

FDA approves expanded use for Medtronic’s Evolut TAVR

Medtronic (NYSE:MDT) announced last week that it received FDA approval for revised commercial labeling on its […]

article

FDA Approved Implantables Neuro

Medtronic announces US launch of its InterStim Micro neurostimulator

Medtronic has announced that its recently US Food and Drug Administration (FDA)-approved InterStim Micro neurostimulator […]

article

FDA Approved Neuro Wearables

Neurolief wins FDA breakthrough nod for wearable neuromod for depression

Neurolief announced today that it received FDA breakthrough device designation for its Relivion DP system for […]

article

FDA Approved MedTech Neuro

Stryker's Neuroform Atlas® Stent System granted an expanded indication, providing a new option for patients with aneurysms in the back of the brain

KALAMAZOO, Michigan, USA, Aug. 3, 2020 /PRNewswire/ — Stryker announced today that it has received U.S. Food and […]

article

FDA Approved MedTech Women's Health

FDA approves Channel Medsystems’ cryotherapy device

Channel Medsystems announced today that it received FDA approval for its next-generation Cerene cryotherapy device for […]

article

Cardiology FDA Approved Structural Heart

Boston Scientific’s next-gen stroke prevention device gets FDA nod

The FDA has approved the next-generation of Boston Scientific’s (NYSE:BSX) Watchman left atrial appendage closure (LAAC) device, […]

article

Cardiology FDA Approved Structural Heart

Edwards’ KONECT RESILIA Aortic Valved Conduit Wins FDA Approval For Bio-Bentalls

Edwards Lifesciences won FDA approval for its KONECT RESILIA aortic valved conduit, a device designed […]

article

Cardiology FDA Approved MedTech

Revamp Medical acute heart failure catheter wins FDA breakthrough device designation

Revamp Medical this week said its Doraya acute heart failure catheter received FDA breakthrough device […]

article

FDA Approved MedTech Neuro

Bridge, The Opioid Withdrawal Therapy Device, Released by Masimo

Masimo has announced that it’s making the Bridge device available, the first electronic therapeutic solution […]

article

Cardiology FDA Approved Surgery

Abbott’s Gallant Heart Rhythm Implants FDA Approved

Abbott won FDA approval for its Gallant implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator […]

article

FDA Approved Implantables Urology

Axonics receives FDA approval for 3T full-body MRI scans

Axonics, a company that has developed and is commercialising novel implantable sacral neuromodulation (SNM) devices […]

article

Cardiology FDA Approved MedTech

Philips Gets FDA Approval for Two New Defibrillators

Philips won FDA approval for its HeartStart FR3 and HeartStart FRx automated external defibrillators (AEDs). […]

article

FDA Approved MedTech Neuro

FDA approves Percept PC neurostimulator with BrainSense technology

Medtronic has announced it received US Food and Drug Administration (FDA) approval for the Percept […]

article

Digital Health FDA Approved MedTech

Move to digital mammography failed to improve outcomes, study finds

Dive Brief: A meta-analysis of 24 studies has found the move from film to digital […]

article

FDA Approved Implantables Neuro

Medtronic's brain-reading stimulator nets FDA approval

The FDA has approved Medtronic’s latest deep-brain stimulation implant, featuring the ability to read, capture […]

article

Cardiology FDA Approved MedTech

Philips wins FDA approval for new automated external defibrillators

Royal Philips (NYSE:PHG) announced today that FDA has granted premarket approval for the company’s HeartStart FR3 […]

article

FDA Approved Implantables Neuro

Mainstay Medical Announces U.S. FDA Approval of ReActiv8® Neurostimulation System for Chronic Low Back Pain

June 22, 2020 06:00 UTC U.S. commercialization expected to begin in the first half of […]

article

FDA Approved Implantables Neuro

FDA approval for Axonics’ wireless patient Remote Control with SmartMRI technology

Axonics, a company that has developed implantable sacral neuromodulation (SNM) devices for the treatment of […]

article

FDA Approved Orthopedic Spine

Centinel Spine announces approval for the manufacturing transfer of prodisc technology

Centinel Spine has announced US Food and Drug Administration (FDA) approval for the manufacturing transfer […]

Topic: FDA Approved

FDA approves Nevro spinal cord stimulation to treat chronic pain with diabetic neuropathy

Medtronic bags FDA approval for Vanta implantable neurostimulator

Cardinal Health wins new FDA approval for Lymphoseek

FDA approves “first-of-its-kind” SenSight Directional Lead System for DBS therapy

Medtronic gains FDA approval to trial implantable tibial neuromodulation device

FDA approves Medtronic Pipeline Flex with Shield Technology to treat brain aneurysms

NuVasive’s Simplify Disc gains FDA approval for use in two-level cTDR

Medtronic’s Harmony pulmonary valve wins FDA approval

PMA submission process initiated for FDA approval of Limiflex

FDA approval brings remote programming for Abbott’s deep brain stimulation device

FDA authorizes Q-Collar to help protect athletes’ brains

FDA approves 3D-printed ankle implant for humanitarian use

Medtech Miniaturization: How Tiny Devices Make a Big Impact

FDA Approves First Prosthetic Implant for Above-Knee Amputees

Vercise Genus DBS system received FDA approval

DiamondTemp Ablation System FDA Approved for AFib

Vercise Genus Deep Brain Stimulation for Parkinson’s FDA Approved

How continuous glucose monitors have transformed the diabetes landscape

Medtronic-Axonics sacral neuromod patent battle heats up

FDA approves Medtronic MiniMed 770G insulin pump for young children

FDA approves expanded use for Medtronic’s Evolut TAVR

Medtronic announces US launch of its InterStim Micro neurostimulator

Neurolief wins FDA breakthrough nod for wearable neuromod for depression

Stryker's Neuroform Atlas® Stent System granted an expanded indication, providing a new option for patients with aneurysms in the back of the brain

FDA approves Channel Medsystems’ cryotherapy device

Boston Scientific’s next-gen stroke prevention device gets FDA nod

Edwards’ KONECT RESILIA Aortic Valved Conduit Wins FDA Approval For Bio-Bentalls

Revamp Medical acute heart failure catheter wins FDA breakthrough device designation

Bridge, The Opioid Withdrawal Therapy Device, Released by Masimo

Abbott’s Gallant Heart Rhythm Implants FDA Approved

Axonics receives FDA approval for 3T full-body MRI scans

Philips Gets FDA Approval for Two New Defibrillators

FDA approves Percept PC neurostimulator with BrainSense technology

Move to digital mammography failed to improve outcomes, study finds

Medtronic's brain-reading stimulator nets FDA approval

Philips wins FDA approval for new automated external defibrillators

Mainstay Medical Announces U.S. FDA Approval of ReActiv8® Neurostimulation System for Chronic Low Back Pain

FDA approval for Axonics’ wireless patient Remote Control with SmartMRI technology

Centinel Spine announces approval for the manufacturing transfer of prodisc technology