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.
BIOLASE and EdgeEndo Announce FDA 510(k) Clearance of New EdgePRO Laser-Assisted Microfluidic Irrigation Device for Endodontists
The new laser-assisted microfluidic irrigation device offers an advanced solution to current cleaning and disinfection techniques, without disrupting procedure workflow or adding substantial cost on a per-procedure basis.
Endotronix Announces FDA Approval for PROACTIVE-HF Pivotal Trial Design Change to Single-Arm Study
"The FDA's decision is great news for our PROACTIVE-HF study patients – they now have immediate access to technology that is designed to keep them healthier and out of the hospital. Furthermore, it is an important acknowledgement for the therapeutic category and the benefits that PA pressure-guided heart failure management enables," stated Harry Rowland, CEO of Endotronix.
NuVasive Receives FDA Clearance for Expanded Indications of Use for Attrax Putty with Company’s Thoracolumbar Interbody Portfolio
"The expanded indications of Attrax Putty with thoracolumbar implants support the clinical efficacy of Attrax Putty and highlight the comparative clinical advantage over competitive biologic offerings in the market," said Ryan Donahoe, chief technology officer at NuVasive.
Zynex Submits FDA Application for its Next Generation Fluid and Blood Volume Monitor
The Zynex Fluid Monitoring System (CM-1500) is a 100% non-invasive solution for monitoring fluid changes throughout patient care environments.
Paragon 28, Inc. R3ACT™ Stabilization System Cleared by FDA
The R3ACT™ Stabilization System, expected to commercially launch in early 2022, will complement the company's comprehensive ankle fracture and soft tissue portfolio and further expands their product offering in the foot and ankle space.
Nobel Biocare Receives FDA 510(k) Clearance for the Nobel Biocare N1™ Implant System
More than an implant, N1 is a comprehensive system of dedicated instruments, prosthetic components, and surgical protocols.
Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults
"Today's authorization provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally. Molnupiravir is limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death," said Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research. "As new variants of the virus continue to emerge, it is crucial to expand the country's arsenal of COVID-19 therapies using emergency use authorization, while continuing to generate additional data on their safety and effectiveness."
OrganOx Receives FDA Approval for its Liver Normothermic Machine Perfusion System
To date, the metra has supported more than 1,200 liver transplants worldwide, with several individual centers in Europe having transplanted more than 100 donor livers using our system.
MOWOOT earns FDA’s First-Ever ‘Breakthrough Device Designation’ for a Novel Non-Drug and Non-Invasive Therapy of Neurogenic Bowel Disorder
"The Breakthrough Device Designation is a significant milestone for our company and validates our belief that our solution offers significant advantages over existing approved or cleared alternatives, per FDA requirements." said Dr. Markus Wilhelms, CEO and cofounder of MOWOOT.
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