FDA Approved Archives - TMG Pulse

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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, […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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). […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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Cardiology FDA Approved MedTech

CardioFocus Announces US FDA Approval of HeartLight® X3 System for the Treatment of Atrial Fibrillation

MARLBOROUGH, Mass., May 12, 2020 /PRNewswire/ — CardioFocus, Inc. today announced that the U.S. Food and Drug Administration […]

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FDA Approved Healthcare Oncology

Novocure posts data from post-approval brain cancer device trial

Dive Brief: Oncology medtech Novocure presented data Monday from a non-inferiority study run to meet […]

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FDA Approved Implantables Vascular

Tack Endovascular System® Receives FDA Approval for Below-the-Knee Post-Angioplasty Dissection Repair

Intact Vascular’s Tack Endovascular System is a First-of-its-Kind Vascular Implant for Optimized Balloon Angioplasty Outcomes […]

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FDA Approved Implantables Neuro

Axonics wins FDA approval for its next-generation implantable neurostimulator

Axonics has announced the US Food and Drug Administration (FDA) approval of its next-generation rechargeable […]

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FDA Approved Orthopedic Spine

Centinel Spine receives FDA approval for two-level indications of prodisc L TDR

Centinel Spine has announced US Food and Drug (FDA) approval of two-level indications for the […]

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FDA Approved MedTech Respiratory

Xerox set to mass produce Vortran’s disposable emergency ventilators

Xerox is partnering with the ventilator manufacturer Vortran to help mass produce its portable, disposable […]

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Drug-delivery FDA Approved Respiratory

FDA approves Cipla’s generic albuterol inhaler

The FDA approved the first generic version of the Proventil HFA (albuterol sulfate) metered-dose inhaler […]

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FDA Approved Urology

Olympus lands FDA de Novo approval for benign hyperplasia device

Olympus (TYO:7733) announced today that it received FDA de Novo classification for its iTind non-surgical device […]

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Cardiology FDA Approved

Zoll Medical wins FDA nod for second-gen TherOx system

Zoll Medical Corp. announced today that it received FDA approval for its second-generation TherOx system for […]

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FDA Approved Women's Health

Aegea Medical device to treat heavy menstrual bleeding wins FDA approval

Aegea Medical this week said it won FDA approval for its Mara Water Vapor Ablation […]

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Drug-delivery FDA Approved Implantables

FDA approves BioStage’s esophageal device investigational new drug application

Biostage (NSDQ:BSTG) this week announced that its Cellspan Esophageal Implant investigational new drug application won FDA […]

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Cardiology Digital Health FDA Approved

FDA allows AliveCor’s AI ECG to detect coronavirus drug-induced heart problems

While rivals worked to build basic ECG functionality into smartwatches, AliveCor received FDA approval last year […]

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Cardiology FDA Approved Structural Heart

Endologix wins FDA approval for abdominal stent graft system

Endologix today said it received FDA approval for its Alto Abdominal Stent Graft System. The […]

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FDA Approved Imaging Neuro

NeuroPace RNS System receives FDA approval for MRI Labeling, allowing thousands more patients to benefit from personalised, data-driven epilepsy treatment

NeuroPace has announced that its RNS System has received US Food and Drug Administration (FDA) […]

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FDA Approved Neuro

NeuroPace wins FDA approval of MRI labeling for its neurostim system

NeuroPace announced today that FDA approval of MRI labeling for its RNS system for people living […]

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Cardiology FDA Approved Pediatrics Surgery

Masimo Receives FDA Approval for Continuous RRp Monitoring

Masimo announced that it received FDA clearance for continuous RRp (respiration rate from the photoplethysmograph) […]

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FDA Approved Funding Neuro

Cerus Endovascular receives FDA Approval for its first microcatheter

Cerus Endovascular receives US FDA approval for its first microcatheter. The 021 microcatheter will be […]

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Cardiology FDA Approved Structural Heart

Cardiovalve scores FDA wins for its transcatheter tricuspid valve replacement tech

Cardiovalve (Or Yehuda, Israel) said today that U.S. FDA has granted a breakthrough device designation for […]

Topic: FDA Approved

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

CardioFocus Announces US FDA Approval of HeartLight® X3 System for the Treatment of Atrial Fibrillation

Novocure posts data from post-approval brain cancer device trial

Tack Endovascular System® Receives FDA Approval for Below-the-Knee Post-Angioplasty Dissection Repair

Axonics wins FDA approval for its next-generation implantable neurostimulator

Centinel Spine receives FDA approval for two-level indications of prodisc L TDR

Xerox set to mass produce Vortran’s disposable emergency ventilators

FDA approves Cipla’s generic albuterol inhaler

Olympus lands FDA de Novo approval for benign hyperplasia device

Zoll Medical wins FDA nod for second-gen TherOx system

Aegea Medical device to treat heavy menstrual bleeding wins FDA approval

FDA approves BioStage’s esophageal device investigational new drug application

FDA allows AliveCor’s AI ECG to detect coronavirus drug-induced heart problems

Endologix wins FDA approval for abdominal stent graft system

NeuroPace RNS System receives FDA approval for MRI Labeling, allowing thousands more patients to benefit from personalised, data-driven epilepsy treatment

NeuroPace wins FDA approval of MRI labeling for its neurostim system

Masimo Receives FDA Approval for Continuous RRp Monitoring

Cerus Endovascular receives FDA Approval for its first microcatheter

Cardiovalve scores FDA wins for its transcatheter tricuspid valve replacement tech