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.
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.
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.”
Deep Blue Medical Advances Announces FDA Clearance for Sublay Application in Hernia Surgery, Enabling Broader Use of T-Line Hernia Mesh
Deep Blue's T-Line hernia mesh design includes novel mesh extensions that provide superior anchor strength designed to prevent mesh fixation failure.
Triastek Receives FDA IND Clearance for 3D Printed Medicine for the Treatment of Ulcerative Colitis
Dr. Senping Cheng, founder and CEO of Triastek. "Delaying drug release and delivering oral dosage forms to the colon is challenging, so T21 offers a promising new option for patients by providing site-specific drug delivery and localized drug effect, mitigating potential side effects from systemic exposure. We look forward to advancing this treatment into the clinic and appreciate the FDA's support. "
SafeSource Direct Receives FDA Clearance for American-Made PPE
Justin Hollingsworth, CEO, SafeSource Direct. “While COVID-era shortages and substandard products may seem like things of the past, the risk that our nation’s healthcare providers find themselves in a similar situation remains very real. That’s why we’re offering a solution that sidesteps the supply interruptions and lack of quality control that come with dependence on foreign manufacturers.”
Evolution Optiks Limited Completes Enrollment of U.S. FDA Clinical Study of LFR-260 Phoropter
Andreas Kusay, Chairman of Evolution Optiks, adds: "The regulatory clearance of the LFR-260 to be used as a tele-operable phoropter would add a very attractive solution to a rather stagnant market and unlock a significant addressable market expansion opportunity.
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