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.
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
Gamida Cell’s Allogeneic Cell Therapy Omisirge ® (omidubicel-onlv) Receives FDA Approval
Omisirge is approved by the FDA as a new donor source for allogeneic stem cell transplant. Global, randomized Phase 3 clinical trial showed faster neutrophil recovery and reduced bacterial and fungal infections as compared to standard cord blood. Omisirge may increase access to stem cell transplant, including among patients from diverse backgrounds .
Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on REXULTI ® (brexpiprazole) for the Treatment of Agitation...
If approved, REXULTI would be the first FDA-approved treatment indicated for AAD in the U.S. The FDA will consider the feedback from the committee as it reviews the sNDA for REXULTI in advance of the May 10 Prescription Drug User Fee Act (PDUFA) target action date.
Dr Peter Marks of FDA to Keynote 2023 Bio Innovation Conference Hosted by Maryland Life Sciences
“Dr Peter Marks has been at the forefront of cell and gene therapy advances for more than a decade,” said Kelly Schulz, CEO of the Maryland Tech Council. “Bio Innovation Conference attendees will be fortunate to hear Dr. Marks’ unique insights into the future of cell and gene therapy and how to make them a reality for patients around the world.”
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