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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.
The MIRA Surgical System Proceeds to FDA Substantive Review for Market Authorization Under the De Novo Classification Pathway
If granted, MIRA surgical system will become the first robotic-assisted surgery device to obtain marketing authorization through the De Novo pathway for use in bowel resection procedures, making it a trailblazer in soft tissue robotics. Beyond granting Virtual Incision the ability to commercialize MIRA in the U.S. for its intended use, an authorization may lay the foundations for expanded procedural indications, entry into international markets, additional instruments and accessories, and future generations of the surgical system
BD Gains 510(k) Clearance of Artificial Intelligence Software for MRSA Diagnostics
The MRSA imaging application uses AI algorithms to look for specific culture characteristics on the BBL™ CHROMagar™ MRSA II plate. Based on that information and analysis by BD Synapsys™ informatics, plate images are automatically organized and sorted into meaningful worklists for laboratory scientists and technicians.
Hubly Surgical Receives 510k Clearance from FDA to Market Innovative Cranial Access Drill for Neurosurgical Safety in the ICU
The Hubly Drill aims to mitigate the challenges of bedside cranial access by being the first and only cordless single-use cranial drill with advanced features for safety and efficiency in any setting. "Essentially we are bringing the precision of the operating room, which physicians are accustomed to, to the bedside," said Founder/CEO Casey Grage.
Omeq Medical Receives FDA Regulatory Clearance for its Smart Device for Epidural Injections
Omeq Medical CEO, Lior Margalit remarked, "We are grateful to the anesthesia community that has supported our development. We now turn our focus to bring EpiFinder to US patients receiving epidural injections. EpiFinder offers the potential to become the new standard of care while performing LOR.
HAPPE Spine Announces FDA Clearance for the INTEGRATE-C™ Interbody Fusion System
The INTEGRATE-C™ system offers a multitude of sizes and lordotic angles to accommodate patient anatomy. The company's commercialization strategy is presently focused on a limited user release to establish efficacy with clinical data notes HAPPE Spine.
Norlase Receives FDA 510(k) Clearance and CE Mark Approval For ECHO™ Green Pattern Laser
The ECHO™ Green Pattern Laser nd scanner are completely integrated into a single delivery device that attaches to compatible slit lamps.
Cumulus Neuroscience Receives FDA 510(k) Clearance for Award-Winning, First-In-Class Neurophysiology Platform for At-Home Use
"Receiving 510(k) clearance from the FDA marks a major milestone for Cumulus, and for our biopharma innovator partners in the US and Europe who need the ability to capture clinical-grade, EEG signals from patients while at-home, to accelerate their development programs for precision CNS medicines," said Brian Murphy, Founder and Chief Scientific Officer, Cumulus Neuroscience.
Next generation Micra Leadless Pacemaker System Receives FDA Approval Reports Medtronic
Micra AV2 and Micra VR2, the world's smallest micra leadless pacemaker, provides longer battery life and easier programming than prior Micra pacemakers, while still delivering the many benefits of leadless pacing such as reduced complications compared to traditional pacemakers.
Apyx Medical Corporation Receives FDA 510(k) Clearance for the Use of Renuvion® for Coagulation of Subcutaneous Soft Tissues Following Liposuction for Aesthetic Body Contouring
Charlie Goodwin, President and Chief Executive Officer of Apyx Medical. “This 510(k) clearance further demonstrates the safety and effectiveness of our Renuvion technology, and our continued commitment to working with the FDA to secure specific clinical indications.”
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