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Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
Dyad Medical Secures FDA Clearance For Echo:Prio Cardiac Imaging Analysis Platform
The FDA’s clearance of Dyad Medical’s Echo:PrioTM application allows us to provide operators and physicians an essential computer-assisted tool for echocardiographic analysis.
CerroZone Receives FDA 510(k) Class II Clearance
The CerroZone mobile unit is designed to purify air in buildings such as schools, retail environments, offices, and other indoor spaces.
Dyad Medical Secures FDA Clearance For Echo:Prio ™ Cardiac Imaging Analysis Platform
Echo:Prio, part of the complete cardiac platform named Libby®, offers fast, data-driven image analysis of echocardiogram images. It is an important decision-making support tool for index quantification of cardiac function saving the clinician time in diagnosis and treatment-decision making.
Avenda Health Receives FDA Investigational Device Exemption for AI-enabled Prostate Cancer Therapy
Avenda Health said the IDE will allow these two technologies to be used together in a randomized control trial to show superiority over standard of care for the treatment of prostate cancer.
MedAlliance SELUTION SLR Receives Second FDA IDE Approval
Enrollment will begin in the SELUTION SLR IDE SFA study later this year. It will be conducted at over 20 centers in the US and an additional 20 centers around the world advises MedAlliamce.
Movano Ring Exceeds Accuracy Targets for SpO2 and Heart Rate Monitoring in Initial Hypoxia Study; Company Eyes FDA Submission
Vital health metric demonstrates wearable’s potential to properly track heart health and detect possible illnesses reports Movano.
NeuroOne Submits Special 510(k) to FDA for Evo® sEEG Electrode
Dave Rosa, Chief Executive Officer of NeuroOne, states, "Our employees and contractors worked exceptionally hard to expedite the testing and resubmission of our sEEG electrode 510(k) application ahead of our timeline. We are excited with the results provided by an accredited independent test facility and look forward to continuing the dialogue with FDA regarding this submission to reach a successful conclusion."
MicroPort Navibot Receives 510(K) Clearance for SkyWalker™, the Company’s First Robot-Assisted Platform for Orthopedic ApplicationsI
The SkyWalker Total Knee System is the first robot-assisted platform from MicroPort and will initially offer a robotically assisted total knee replacement solution compatible with its Evolution Medial-Pivot knee system
Pulse Biosciences Receives FDA 510(k) Clearance of Expanded Energy Settings for use with the CellFX® System
A company spokesperson said, "We are pleased with how quickly the FDA cleared these new energy settings based on the data we provided, requiring 53 of the allotted 90-day review period, to determine that the expanded settings are safe and effective for use with the CellFX System. We appreciate the ongoing collaboration with FDA as we continue to expand the clinical applications for the CellFX System.”