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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.
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.
BD Receives FDA Emergency Use Authorization for COVID-19, Influenza A/B, RSV Combination Test
The BD MAX™ System is already in use at thousands of hospitals and laboratories worldwide, and each unit is capable of analyzing hundreds of samples over a 24-hour period.
FDA Agrees to Expanded Access Program for the BioVentrix® Revivent TC System for the Treatment of Ischemic Heart Failure
The BioVentrix Revivent TC System is designed to support a minimally invasive procedure to treat a dilated left ventricle of patients with ischemic heart failure with reduced ejection fraction (HFrEF) and extensive left ventricular scar, who have a suboptimal response to guideline-directed medical therapy.
VySpine Announces FDA Clearance for LumiVy Lumbar IBF with NanoVy Ti
The LumiVy NanoVy Ti Lumbar IBF System features VySpine's NanoVy Ti coating technology in partnership with Implant Surfaces. NanoVy Ti is a titanium coating that is mere nanometers thick, adhered to a PEEK LumiVy implant. The NanoVy Ti coating is engineered to facilitate direct osteoblast attachment to the entire surface of the LumiVy implant.
DropSafe Sicura, An Innovative Hypodermic Needle with a Transparent Safety Shield and Fully Automated Safety Mechanism, Received US FDA 510(k) Clearance
DropSafe Sicura passive safety needle, an innovative injection needle with a fully passive mechanism that can be used for the intramuscular and subcutaneous injection of vaccines and other drugs.
CardiacSense receives FDA Clearance for Medical Watch
Samuel Viskin MD, Senior Electrophysiologist at Tel Aviv Medical Center, Israel and advisor to CardiacSense commented "the CSF-3 medical grade vital sign monitor from CardiacSense has the potential to dramatically improve the care we provide to patients with Cardiac Arrythmias like Atrial Fibrillation, as well as patients with chronic conditions like Heart Failure and COPD."
Bresotec’s BresoDX1 for At-Home Sleep Apnea Testing Receives FDA 510(k) Clearance
Bresotec Medical founder and Chief Medical Officer, Dr. Douglas Bradley, MD, FRCP, FCAHS, stated that, “Through the collection of tracheal breath sounds and motion, Bresotec’s proprietary technology utilizes respiratory airflow as its primary means of measurement. This unique approach, coupled with strong clinical validation, leaves BresoDX1 uniquely positioned to address the growing, but under-served opportunity in at-home sleep apnea diagnosis.”