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Biosense Webster Submits Application to U.S. FDA Seeking Approval of the VARIPULSE Platform for the Treatment of Paroxysmal Atrial Fibrillation

Biosense Webster Submits Application to U.S. FDA Seeking Approval of the VARIPULSE Platform for the Treatment of Paroxysmal Atrial Fibrillation
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United-states , Japan , Biosense-webster , Johnson-medtech , Service-pack-software , Biosense-webster-inc , Japan-ministry-of-health , Us-food-drug-administration , Premarket-approval-application , Drug-administration , Jasmina-brooks , Treatment-management

InspireMD Announces Abstract of One-Year Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial Accepted for Presentation at LINC 2024

InspireMD Announces Abstract of One-Year Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial Accepted for Presentation at LINC 2024
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Miami , Florida , United-states , Germany , Israel , Leipzig , Sachsen , Ohio , Marvin-slosman , Chris-metzger , Chuck-padala , Clinical-events-committee

InspireMD Announces Abstract of One-Year Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial Accepted for Presentation at LINC 2024

TEL AVIV, Israel and MIAMI, March 26, 2024 -- InspireMD, Inc. , developer of the CGuard™ Embolic Prevention Stent System for the prevention of stroke, today announced that an abstract of the...

Germany , Miami , Florida , United-states , Ohio , Israel , Leipzig , Sachsen , Marvin-slosman , Chuck-padala , Chris-metzger , Inspiremd-inc

Biosense Webster Submits Application to U.S. FDA Seeking Approval of the VARIPULSEtm Platform for the Treatment of Paroxysmal Atrial Fibrillation

Biosense Webster Submits Application to U.S. FDA Seeking Approval of the VARIPULSEtm Platform for the Treatment of Paroxysmal Atrial Fibrillation
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Framingham , Massachusetts , United-states , Japan , California , Boston , Irvine , Emeliaj-benjamin , Biosense-webster , Johnson-medtech , Prnewswire-biosense-webster-inc , Circulation-research

Are Higher Standards for Expedited FDA Approvals Needed?

Many clinicians have reported a lack of understanding of the FDA approval process and a desire for strong premarket evidence to support these approvals.

Sanket-dhruva , University-of-california-san-francisco , Health-affairs , Health-aff-millwood , California-san-francisco , Breakthrough-therapy , Innovation-act , Into-priority-review , Accelerated-approvals , Prescription-drug-user-fee-act , Humanitarian-device-exemption , Premarket-notification

InspireMD Receives CE Mark Recertification Under EU's New Medical Device Regulation (MDR) Regulatory Framework

InspireMD Receives CE Mark Recertification Under EU's New Medical Device Regulation (MDR) Regulatory Framework
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United-states , Israel , Miami , Florida , Chuck-padala , Marvin-slosman , European-union , Exchange-commission , Nasdaq , Inspiremd-inc-inspire , Company-annual-report-on-form , Craig-shorechief-financial-officerinspiremd-inc

InspireMD (NSPR) Receives CE Mark Recertification Under EU's New Medical Device Regulation (MDR) Regulatory Framework

InspireMD (NSPR) Receives CE Mark Recertification Under EU's New Medical Device Regulation (MDR) Regulatory Framework
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Marvin-slosman , European-union , Nasdaq , Inspiremd-inc , Embolic-prevention-carotid-stent-system , Medical-device-regulation , Premarket-approval-application ,

Nemaura Medical, Inc: Important Update on Listing Status and Strategic Direction

Nemaura Medical, Inc: Important Update on Listing Status and Strategic Direction
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United-kingdom , United-states , Drug-administration , Nemaura-medical-inc , Nasdaq , Exchange-commission , Nemaura-medical , Nasdaq-capital-market , Future-success , Investor-relations , Premarket-approval-application

Nemaura Medical Inc. Secures $10 Million Non-Dilutive Credit Facility to Fuel Strategic Growth

Nemaura Medical Inc. Secures $10 Million Non-Dilutive Credit Facility to Fuel Strategic Growth
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United-states , United-kingdom , Drug-administration , Nasdaq , Exchange-commission , Nemaura-medical-inc , Nemaura-medical , Premarket-approval-application , Statement-regarding-forward-looking-statements , United-states-securities , Annual-report

Nemaura Medical Inc. Secures $10 Million Non-Dilutive Credit Facility To Fuel Strategic Growth

Nemaura Medical Inc. Secures $10 Million Non-Dilutive Credit Facility To Fuel Strategic Growth
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United-kingdom , Nemaura-medical-inc , Nasdaq , Nemaura-medical , Premarket-approval-application ,