Tag: FDA premarket approval

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Microbot Medical Submits Liberty Robotic System For FDA Review

Microbot Medical has submitted a 510(k) notification for Liberty, its single-use robotic system for endovascular procedures.

FDA Classifies Intravenous Catheter Force-Activated Separation Devices as Class II
FDA Issues Final Guidance for Medical Device Cybersecurity
Synapse Biomedical’s Diaphragm Pacing System Gets FDA Premarket Approval
Seno Medical’s Breast Imaging System Receives FDA Premarket Approval
FDA Grants Premarket Approval for AccelStim Bone Growth Stimulation Device
FDA Approves Senseonics’ Continuous Glucose Monitoring System

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FDA OKs Whole Breast Ultrasound Tomography System

Delphinus Medical Technologies, Inc. announces that the U.S. FDA has granted premarket approval of its SoftVue 3D Whole Breast Ultrasound Tomography System for use as an adjunct to digital mammography in the screening of asymptomatic women with dense breast tissue.

Kestra Medical Technologies Nabs FDA Premarket Approval for Wearable Cardioverter Defibrillator
Why Courts Should Bring Back Evidence of FDA Clearance in Medical Device Trials
FDA Announces More Class II Medical Device 510(k) Exemptions
FDA Grants Premarket Approval to Xvivo Lung Device

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Microbot Medical Submits Liberty Robotic System For FDA Review

Microbot Medical has submitted a 510(k) notification for Liberty, its single-use robotic system for endovascular procedures.

FDA Classifies Intravenous Catheter Force-Activated Separation Devices as Class II
FDA Issues Final Guidance for Medical Device Cybersecurity
Synapse Biomedical’s Diaphragm Pacing System Gets FDA Premarket Approval
Seno Medical’s Breast Imaging System Receives FDA Premarket Approval
FDA Grants Premarket Approval for AccelStim Bone Growth Stimulation Device
FDA Approves Senseonics’ Continuous Glucose Monitoring System

Tag: FDA premarket approval

All

Microbot Medical Submits Liberty Robotic System For FDA Review

FDA Classifies Intravenous Catheter Force-Activated Separation Devices as Class II

FDA Issues Final Guidance for Medical Device Cybersecurity

Synapse Biomedical’s Diaphragm Pacing System Gets FDA Premarket Approval

Seno Medical’s Breast Imaging System Receives FDA Premarket Approval

FDA Grants Premarket Approval for AccelStim Bone Growth Stimulation Device

FDA Approves Senseonics’ Continuous Glucose Monitoring System

All

FDA OKs Whole Breast Ultrasound Tomography System

Kestra Medical Technologies Nabs FDA Premarket Approval for Wearable Cardioverter Defibrillator

Why Courts Should Bring Back Evidence of FDA Clearance in Medical Device Trials

FDA Announces More Class II Medical Device 510(k) Exemptions

FDA Grants Premarket Approval to Xvivo Lung Device

All

Sorry, No Posts Found

All

Microbot Medical Submits Liberty Robotic System For FDA Review

FDA Classifies Intravenous Catheter Force-Activated Separation Devices as Class II

FDA Issues Final Guidance for Medical Device Cybersecurity

Synapse Biomedical’s Diaphragm Pacing System Gets FDA Premarket Approval

Seno Medical’s Breast Imaging System Receives FDA Premarket Approval

FDA Grants Premarket Approval for AccelStim Bone Growth Stimulation Device

FDA Approves Senseonics’ Continuous Glucose Monitoring System

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