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Submissions and Approvals
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FDA Clears Additional Indication for GT Medical’s Brain Tumor Therapy

January 30, 2020

The device is used following brain tumor removal. Read More

Abbott Earns CE Mark for Mitral Regurgitation Therapy

January 30, 2020

The system is an alternative for patients who are at high risk for open-heart surgery. Read More

BioIntelliSense’s Remote Care Body Sensor Grabs FDA Clearance

January 30, 2020

The sensor can keep track of a patient’s heart rate, respiratory rate, skin temperature, activity and posture. Read More

Beckman Coulter’s Procalcitonin Assay Cleared

January 29, 2020

Procalcitonin levels in blood have been found to correlate with the severity of bacterial infections. Read More

Sony Receives FDA Clearance for Digital Imaging System

January 29, 2020

The encrypted system can be expanded for use in additional hospital rooms or buildings. Read More

FDA Clears Mauna Kea’s Endomicroscopy Platform for Use with Fluorescent Dye

January 29, 2020

The new indication allows the platform to be used “with highly specific molecular imaging markers.” Read More

Eko Earns FDA Clearance for Atrial Fibrillation, Heart Murmur Algorithms

January 29, 2020

Eko said it plans to seek FDA approval for additional cardiac screening algorithms. Read More

FDA Grants Premarket Approval for Intact Vascular’s Dissection Repair Device

January 28, 2020

The device features adaptive sizing, which allows the implant to adapt to tapering vessels. Read More

Imricor Earns CE Mark for MRI Ablation Catheter

January 27, 2020

The catheter is designed to enable “faster and safer treatment,” the company said. Read More

FDA Approves Another Indication for Abbott’s Brain Stimulation System

January 27, 2020

The system is now approved for all major target areas in treating movement disorders, Parkinson’s disease and essential tremor, the company said. Read More

Boston Scientific Gains CE Mark for Single-Use Duodenoscope

January 24, 2020

The single-use design avoids the need for reprocessing of reusable devices. Read More

Verily Nabs 510(k) Clearance for Study Watch with Irregular Pulse Monitor

January 24, 2020

Study Watch will not be directly available to consumers, the company said. Read More

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Submissions and Approvals
RSS

FDA Clears Additional Indication for GT Medical’s Brain Tumor Therapy

Abbott Earns CE Mark for Mitral Regurgitation Therapy

BioIntelliSense’s Remote Care Body Sensor Grabs FDA Clearance

Beckman Coulter’s Procalcitonin Assay Cleared

Sony Receives FDA Clearance for Digital Imaging System

FDA Clears Mauna Kea’s Endomicroscopy Platform for Use with Fluorescent Dye

Eko Earns FDA Clearance for Atrial Fibrillation, Heart Murmur Algorithms

FDA Grants Premarket Approval for Intact Vascular’s Dissection Repair Device

Imricor Earns CE Mark for MRI Ablation Catheter

FDA Approves Another Indication for Abbott’s Brain Stimulation System

Boston Scientific Gains CE Mark for Single-Use Duodenoscope

Verily Nabs 510(k) Clearance for Study Watch with Irregular Pulse Monitor

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New!

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Submissions and Approvals RSS

New!

17th Medical Device Quality Congress

Submissions and Approvals
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