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Topic: FDA Approved

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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 […]

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