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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.
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."
Compression Works Receives Additional 510(k) Clearance from the FDA for the AAJT-S Life-Saving Junctional Tourniquet
The AAJT-S junctional tourniquet is designed to control non-compressible hemorrhages in the junctional areas of the anatomy, on the abdomen and for pelvic fracture stabilization. “We are thrilled at the ever-expanding indication range for the AAJT-S and are happy to announce this new clearance by the FDA,” said President and CEO of Compression Works Scott Dodson. “Pelvic fractures that result from automobile accidents, crushing injuries and falls represent a serious health issue and even mortality for accident victims due to their potential to rupture the underlying blood vessels in this area,” said Dodson.
FDA Grants Lenire® Tinnitus Treatment Device De Novo Approval
Neuromod Devices’ non-invasive device, Lenire, is the first of its kind granted approval to treat tinnitus in the US market.
Research Park at Florida Atlantic UniversityR Based FloSpine Receives FDA Clearance for 3D Printed Titanium Cervical Implant
The Ti-Largo™ Cervical Interbody Cage System is used to support the spine after a cervical collapse or damaged disc has been removed and is replaced with the Ti-Largo implant to restore the height.
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