Cardiology FDA Approved

Zoll Medical wins FDA nod for second-gen TherOx system

Released on March 30, 2020

Zoll Medical Corp. announced today that it received FDA approval for its second-generation TherOx system for SuperSaturated Oxygen (SSO2) therapy in heart […]

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FDA Approved Women's Health

Aegea Medical device to treat heavy menstrual bleeding wins FDA approval

Released on March 26, 2020

Aegea Medical this week said it won FDA approval for its Mara Water Vapor Ablation System. The Mara System is an […]

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Drug-delivery FDA Approved Implants

FDA approves BioStage’s esophageal device investigational new drug application

Released on March 26, 2020

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

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Cardiology Digital Health FDA Approved

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

Released on March 23, 2020

While rivals worked to build basic ECG functionality into smartwatches, AliveCor received FDA approval last year for a first-of-kind six-lead consumer ECG — […]

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Cardiology FDA Approved Structural Heart

Endologix wins FDA approval for abdominal stent graft system

Released on March 16, 2020

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

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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

Released on March 10, 2020

NeuroPace has announced that its RNS System has received US Food and Drug Administration (FDA) approval of MRI labeling for the […]

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FDA Approved Neuro

NeuroPace wins FDA approval of MRI labeling for its neurostim system

Released on March 9, 2020

NeuroPace announced today that FDA approval of MRI labeling for its RNS system for people living with seizures that do not respond […]

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Cardiology FDA Approved Pediatrics Surgery

Masimo Receives FDA Approval for Continuous RRp Monitoring

Released on March 9, 2020

Masimo announced that it received FDA clearance for continuous RRp (respiration rate from the photoplethysmograph) monitoring with its with Rad-97, Radical-7, […]

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FDA Approved Funding Neuro

Cerus Endovascular receives FDA Approval for its first microcatheter

Released on February 25, 2020

Cerus Endovascular receives US FDA approval for its first microcatheter. The 021 microcatheter will be offered with three different distal configurations, […]

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Cardiology FDA Approved Structural Heart

Cardiovalve scores FDA wins for its transcatheter tricuspid valve replacement tech

Released on February 21, 2020

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

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Digital Health FDA Approved Imaging

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

Released on February 14, 2020

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

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Cardiology FDA Approved Structural Heart

8 types of FDA-approved devices that treat the heart

Released on February 14, 2020

Just starting to learn about all of the medical devices out there for treating cardiovascular diseases? The U.S. FDA has a […]

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