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.
FDA Will Follow The Science On COVID-19 Vaccines For Young Children
As schools around the country are re-opening for in-person learning and families are returning to their busy school year schedules, we know many parents...
FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90% of More Than 6.5 Million ‘Deemed’ New Tobacco Products...
As required by statute, a key consideration in their review of premarket tobacco product applications submitted for products like e-cigarettes is to determine whether permitting the marketing of the product would be "appropriate for the protection of the public health," taking into account the risks and benefits to the population as a whole.
Intelivation Technologies received FDA approval for the Advantage-C™ PEEK Cervical Interbody Fusion device
President Amit Sinha stated, "I am excited about the FDA Approval of Advantage-C™ and the myriad of efficiencies this device will bring to both surgeons and hospital systems alike."
NeuroOne® Medical Technologies Corporation Receives FDA 510(k) Clearance for its Evo® sEEG Electrode
"This represents yet another critical milestone met by the Company as we continue to execute our strategy. The next steps for the Company are to expand the sEEG labeling for longer term use, which we believe will be a key part of our commercialization strategy for the Evo sEEG electrode, and complete development of an sEEG ablation electrode/probe for ablation of brain tissue and permanently implanted stimulation electrodes for patients with chronic applications such as epilepsy, Parkinson's disease and chronic back pain," said Dave Rosa, CEO of NeuroOne.
Asensus Surgical Receives FDA 510(k) Clearance for Expansion of Machine Vision Capabilities
Additional Intelligent Surgical Unit™ (ISU™) features will further extend augmented intelligence leadership in surgery.
EndoSound Vision Ultrasound System Receives FDA Breakthrough Device Designation
“The Breakthrough Device Designation is evidence of the transformative potential the EndoSound Vision System presents,” stated Dr. Stephen Steinberg, MD, EndoSound Founder, and President.
Intelivation Technologies Received FDA Approval for the Golden Isles Pedicle Screw System™
Intelivation Technologies President Amit Sinha remarked, "The modularity of the Golden Isles Pedicle Screw System™ enables the surgeon greater versatility, efficiency, and visibility to achieve superior patient outcomes for the most difficult degenerative and traumatic procedures."
Prelivia, a Neurostimulation Device Receives 510k FDA Clearance
The U.S. Food and Drug Administration has provided 510 (k) Clearance for Prelivia, a neurostimulation device developed by Rehabtronics that promotes healthy blood circulation...
MicroTransponder® Receives FDA Approval for Breakthrough Device Benefiting Stroke Survivors
The first-of-its-kind Vivistim® Paired Vagus Nerve Stimulation (VNS) System significantly improves upper limb rehabilitation therapy.
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