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.
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."