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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.
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.”
Innoblative Designs Receives U.S. FDA Breakthrough Device Designation for its SIRA RFA Electrosurgical Device
Richard Stark, CEO of Innoblative Designs. "We believe the SIRA will be a game changer in BCS for breast cancer and we look forward to bringing this important technology to cancer patients."
CardieX Receives FDA 510(K) Clearance for a World-First Vascular Biometric Monitor – the CONNEQT Pulse
The world's first, customizable vascular biometric monitor has received regulatory clearance to provide medical grade arterial heart health metrics to patients and clinicians
VySpine Announces FDA Clearance for UniVy OsteoVy-Ti Cervical IBF with NanoVy-HA
The UniVy OsteoVy-Ti NanoVy-HA Cervical IBF System features VySpine's NanoVy-HA technology in partnership with Promimic AB.
ZEISS Announces U.S. FDA Approval of the CT LUCIA 621P Monofocal IOL, Offering the Unique ZEISS Optic to the U.S. Market
The CT LUCIA 621P Monofocal IOL enables surgeons to treat a wide range of cataract patients while supporting optimized visual outcomes.
Insulet Announces FDA Clearance of Omnipod GO
Omnipod GO is a standalone, wearable, insulin delivery system that provides a fixed rate of continuous rapid-acting insulin for 72 hours.
Neuspera Medical Announces FDA Clearance of Its System for Peripheral Nerve Stimulation
The Neuspera system delivers peripheral nerve stimulation (PNS) through a wireless, less invasive, and more versatile platform than commercially available technology