FDA, Veterans Health Administration Collaborate on Medical Device Innovation and Advancement of Care
The U.S. FDA and the VHA announced a collaboration to help accelerate medical device innovation to further improve and benefit public health.
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Abbot’s Heart Valve Repair Device May Malfunction, FDA Warns
The U.S. FDA is alerting healthcare providers about potential malfunctions with MitraClip Clip Delivery Systems manufactured by Abbott.
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FDA Removes N95 Respirators from Medical Device Shortage List
The U.S. FDA announced the removal of N95 respirators from its medical device shortage list, signaling that demand no longer exceeds supply.
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FDA, Veterans Health Administration Collaborate on Medical Device Innovation and Advancement of Care
The U.S. FDA and the VHA announced a collaboration to help accelerate medical device innovation to further improve and benefit public health.
HeartBeam Announces FDA Submission of Heart Attack Diagnosis Platform
HeartBeam submitted a 510(k) application to the U.S. FDA for its HeartBeam AIMI platform technology for use in diagnosing heart attacks.
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CerroZone Air Purification Device Gets FDA Clearance
CerroZone’s mobile air purification device earned 510(k) Class II clearance from the FDA as an air cleaner for eliminating airborne viruses.
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BrainScope Gets Innovative Tech Contract for Head Injury Triage Medical Device
BrainScope Company was awarded an Innovative Technology contract from Vizient for its novel head injury triage medical device.
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Glaukos Gets FDA 510(k) Clearance of Glaucoma Treatment System
Glaukos Corporation has received 510(k) clearance from the U.S. FDA for the iStent infinite Trabecular Micro-Bypass System.
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The EPA, FDA Tackle Medical Device Sterilization
The Environmental Protection Agency has announced plans to propose an air pollution rule to address emissions of ethylene oxide at commercial sterilizers.
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Rapid Medical Gains FDA Clearance for Small Thrombectomy Device
Rapid Medical received FDA 510(k) clearance for the TIGERTRIEVER 13 thrombectomy device for large vessel occlusions.
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FDA Adds Automated External Defibrillators and Other Medical Devices to Shortage List
The U.S. FDA has expanded its medical device shortage list to include three different types of medical equipment.
