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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.
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.”
BC3 Technologies Receives FDA Clearance for SEAL Hemostatic Wound Spray
SEAL Hemostatic Wound Spray can be used by first responders, in surgical environments, or in battlefield combat. In its pivotal study, SEAL was therapeutically equivalent to other chitosan-based products indicated for hemorrhage.
U.S. FDA Grants GrayMatters Health 510(k) Clearance to Market Prism for PTSD
“This is a first step in making Prism for PTSD available globally, as the company has just initiated a largescale PTSD study with some of the top mental health institutions in Germany, through a European Union grant,” said Rani Cohen, Co-Founder and Executive Chairman ofGrants GrayMatters Health
Viz.ai is First to Receive FDA 510(k) Clearance for AI Algorithm for Abdominal Aortic Aneurysm
TriHealth Vascular Surgeon Dr. Patrick Muck. “We’ve been using the Viz.ai software for the detection of suspected pulmonary embolism over the last several months and have seen improvements in patient care across our institution.”
Lumicell Submits NDA for LUMISIGHT Optical Imaging Agent for Breast Cancer Surgery
The Lumicell DVS is designed by engineers and scientists from MIT, in close partnership with leading breast cancer surgeons, to fit seamlessly within the existing surgical workflow.
Brainomix Receives FDA Clearance for Its Flagship Stroke AI Imaging Software
Recent studies have shown that the implementation of Brainomix software enabled faster treatment by reducing door-in-door-out times by more than one hour, and improved patient outcomes by tripling the number of patients achieving functional independence after stroke, while also increasing the rates of both thrombolysis and thrombectomy by more than 50%.
NuVasive Specialized Orthopedics Expands Indications of Precice Limb Lengthening System to Treat Pediatric Patients
"Precice Limb Lengthening System has over a decade's worth of clinical data and has truly changed the standard of care for my patients," said Dr. John Herzenberg, director of pediatric orthopedics at Sinai Hospital. "This new indication is significant for my practice as the majority of my patients are under the age of 18, and it provides me with the assurance I need to offer Precice as a pediatric LLD solution."