FDA Approved Archives - Page 3 of 4 - TMG Pulse

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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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Digital Health FDA Approved Imaging

Going mobile: FDA clears world's first bedside MRI scanner-on-wheels

The FDA has cleared the world’s first portable MRI system, designed to be wheeled to […]

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Cardiology FDA Approved Structural Heart

8 types of FDA-approved devices that treat the heart

Just starting to learn about all of the medical devices out there for treating cardiovascular […]

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AI FDA Approved Imaging

FDA approves AI that guides untrained clinicians in capturing high-quality cardiac ultrasounds

The FDA approved the first artificial intelligence-powered software designed to assist and guide medical professionals […]

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Drug-delivery FDA Approved Women's Health

Contura wins FDA premarket approval for hydrogel injection

Contura announced that it won FDA premarket approval for its Bulkamid hydrogel injection for treating stress […]

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FDA Approved Implantables Urology

Contura nabs FDA nod for female incontinence device

Dive Brief: Contura has earned FDA approval for an injectable hydrogel to treat stress urinary […]

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Cardiology FDA Approved Structural Heart

Abbott Wins Approval for CATALYST Trial for At-Risk Stroke Patients

Lately, it seems as if Abbott Laboratories has been extremely busy building its structural heart […]

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FDA Approved Neuro

FDA approval of Axonics’ enhanced neurostimulator programmer

Axonics announces US Food and Drug Administration (FDA) approval of an enhanced, second-generation programmer for […]

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FDA Approved Neuro

Abbott receives expanded indication from FDA for directional DBS to treat Parkinson’s disease

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

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Cardiology FDA Approved

FDA grants Medtronic an IDE to study new tech for ablating heart tissue

Medtronic (NYSE:MDT) announced today that it won FDA approval to move forward with an investigational device […]

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Cardiology FDA Approved

FDA OKs latest Medtronic leadless pacemaker, potentially tripling market

Dive Brief: Medtronic said Tuesday it received FDA premarket approval for its Micra AV pacemaker, […]

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FDA Approved Neuro

Axonics wins FDA approval for enhanced neurostimulator programmer

Axonics Modulation Technologies (NSDQ:AXNX) announced today that it won FDA approval for a second-generation programmer for […]

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Cardiology FDA Approved Implantables

BREAKING: Medtronic wins FDA approval for Micra AV

Medtronic (NYSE:MDT) has won FDA approval for its Micra AV — greatly expanding the number of […]

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Cardiology FDA Approved Structural Heart

Abbott to Initiate Trial to Study MitraClip as an Option for Moderate Surgical Risk Patients

ABBOTT PARK, Ill., Jan. 13, 2020 /PRNewswire/ — Abbott (NYSE: ABT) today announced that the U.S. Food and Drug […]

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FDA Approved Neuro Vascular

MicroVention’s FRED flow diverter now FDA approved

MicroVention, a US based subsidiary of Terumo and a global neurovascular company announced the US […]

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FDA Approved Gastroenterology

Colospan wins IDE FDA approval for intraluminal bypass device

Colospan announced today that it won FDA investigational device exemption for its CG-100 temporary intraluminal bypass […]

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Cardiology FDA Approved Structural Heart

Abbott LVAD wins FDA approval for implantation without open heart surgery

Abbott (NYSE:ABT) today announced that FDA has approved implantation of its HeartMate 3 LVAD via lateral […]

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Cardiology FDA Approved

AtriCure Completes Patient Enrollment for aMAZE Trial

AtriCure is rolling into the new year with some significant milestones that help reinforce the […]

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Cardiology FDA Approved

Terumo subsidiary gains FDA nod for aneurysm flow diverter

Dive Brief: FDA awarded premarket approval to Terumo’s MicroVention subsidiary for a flow diversion system […]

Topic: FDA Approved

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

Going mobile: FDA clears world's first bedside MRI scanner-on-wheels

8 types of FDA-approved devices that treat the heart

FDA approves AI that guides untrained clinicians in capturing high-quality cardiac ultrasounds

Contura wins FDA premarket approval for hydrogel injection

Contura nabs FDA nod for female incontinence device

Abbott Wins Approval for CATALYST Trial for At-Risk Stroke Patients

FDA approval of Axonics’ enhanced neurostimulator programmer

Abbott receives expanded indication from FDA for directional DBS to treat Parkinson’s disease

FDA grants Medtronic an IDE to study new tech for ablating heart tissue

FDA OKs latest Medtronic leadless pacemaker, potentially tripling market

Axonics wins FDA approval for enhanced neurostimulator programmer

BREAKING: Medtronic wins FDA approval for Micra AV

Abbott to Initiate Trial to Study MitraClip as an Option for Moderate Surgical Risk Patients

MicroVention’s FRED flow diverter now FDA approved

Colospan wins IDE FDA approval for intraluminal bypass device

Abbott LVAD wins FDA approval for implantation without open heart surgery

AtriCure Completes Patient Enrollment for aMAZE Trial

Terumo subsidiary gains FDA nod for aneurysm flow diverter