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Seno Medical’s Breast Imaging System Receives FDA Premarket Approval

Seno's Imagio Breast Imaging System received supplemental premarket approval from the Center for Devices and Radiological Health of the FDA.

FDA Grants Premarket Approval for AccelStim Bone Growth Stimulation Device
FDA Approves Senseonics’ Continuous Glucose Monitoring System
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

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FDA Grants Premarket Approval to Xvivo Lung Device

The U.S. FDA has granted premarket approval to the Xvivo Perfusion system with steen solution perfusate, which can temporarily ventilate, oxygenate, and pump preservation solution through lungs that were initially thought to be unacceptable for transplant.

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Seno Medical’s Breast Imaging System Receives FDA Premarket Approval

Seno's Imagio Breast Imaging System received supplemental premarket approval from the Center for Devices and Radiological Health of the FDA.

FDA Grants Premarket Approval for AccelStim Bone Growth Stimulation Device
FDA Approves Senseonics’ Continuous Glucose Monitoring System
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

Tag: FDA premarket approval

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