Category:
FDA
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.
Zimmer Biomet Receives FDA Clearance for Identity Shoulder System for Shoulder Replacement
The Identity Shoulder System is a convertible system that uses proprietary technologies to align each surgeon's approach to an individual patient's anatomy, with the goal of alleviating pain and optimizing range of motion.
ABK Biomedical Receives FDA 510(k) Clearance of Easi-Vue Embolic Microspheres
Easi-Vue embolic microspheres for the treatment of patients suffering from arteriovenous malformations and hypervascular tumors.
Boston Scientific Receives FDA Approval for Expanded Labeling of WATCHMAN FLX LAAC Device for Dual Anti-Platelet Therapy as Post-Procedural Medication Option
WATCHMAN FLX is now the only LAAC technology in the United States that allows for either DAPT or OAC immediately following implantation.
Insulet Announces FDA Clearance of Omnipod 5 for Children Aged Two Years and Older with Type 1 Diabetes
Omnipod 5, the first tubeless automated insulin delivery (AID) system in the U.S., was originally cleared for use in individuals aged six and older in January 2022.
Zavation Medical Products, LLC, receives FDA 510K Clearance for Varisync Anterior Cervical Plate and Spacer System As An Addition to its Cervical Spine Portfolio
Varisync, the most recent addition to the Zavation cervical spine portfolio, has been tested and approved for both the independent and synchronized use of its plate and spacer components. This allows Zavation's surgeon partners to use these plate and spacer options together as a system or pair individual components with any of Zavation's existing cervical portfolio options.
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.
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