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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.
Medtronic First to Receive FDA Approval for Pacing the Heart’s Natural Conduction System
Commonly referred to as "conduction system pacing," this approach helps ensure that pacing closely mimics the heart's physiologic contractions, allowing the heart's ventricles to work in coordination.
XACT Robotics ® Receives FDA Clearance for its ACE Xtend™ Remote Control Unit
“The XACT ACE Robotic System has already allowed users to make percutaneous procedures, such as ablations, drainages and biopsies, more accurate, consistent and efficient,” said Shai Meltzer, CEO of XACT Robotics.
New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials
The draft guidance is intended to assist industry, sponsors and institutional review boards (IRBs) when considering the enrollment of children in clinical investigations of drugs, biological products and medical devices.
iMediSync Announces ‘iSyncWave’ EEG Scanner Receives FDA 510k clearance
According to iMediSync, iSyncWave is a dry EEG scanner that does not require the use of electrode gel. It is not only easy to wear the device and measure EEG, but the size of the device can also be adjusted to accommodate various head shapes and align with the internationally standardized 10-20 system.
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.