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.
Via Nova Therapeutics Announces FDA clearance of Investigational New Drug (IND) Application for VNT-101
"We look forward to evaluating VNT-101 in the clinic," said Don Ganem MD, Co-Founder and CEO of Via Nova Therapeutics. "This is an important step to developing a flu antiviral with a novel mechanism of action, and a milestone for Via Nova Therapeutics as we advance our first compound into the clinic."
FDA OK’s ensoETM for Use in Cardiac Ablations to Reduce Risk of Esophageal Injury
Published studies that have examined the use of ensoETM for this purpose include the pilot eCOOL-AF study, the IMPACT study and a large multi-center analysis of over 25,000 patients (in press at the Journal of the American College of Cardiology: Clinical Electrophysiology). These studies have found up to an 83 percent reduction in esophageal injuries, and a significant reduction in risk of atrioesophageal fistula (AEF), one of the most dreaded complications of ablation procedures.
Annalise.ai Receives FDA Clearance and Breakthrough Device Designation
Annalise.ai has also received FDA Breakthrough Device Designation for its obstructive hydrocephalus software tool. This is the first radiology triage device to be granted Breakthrough status since the inception of the FDA Breakthrough Devices Program.
FDA Approves LimFlow System in Patients With Chronic Limb-Threatening Ischemia and No Suitable Endovascular or Surgical Revascularization Options
FDA approval was based on successful outcomes seen in the PROMISE II pivotal trial, recently published in the New England Journal of Medicine, and from positive clinical results seen in earlier studies. In the PROMISE II study, 76% of no-option CLTI patients were able to keep their leg and experienced progressive wound healing, with many having significant pain relief during the time following LimFlow treatment.4
Stryker’s Pangea Systems Receive FDA Clearance
Pangea to offer a comprehensive and versatile portfolio, providing variable-angle plating for a variety of patient populations.
Boston Scientific Announces FDA Approval for the Latest-Generation WATCHMAN FLX ™ Pro Left Atrial Appendage Closure Device
The latest WATCHMAN FLX Pro device is enhanced with a coating designed to reduce device-related thrombus and enable faster, controlled healing and endothelization of the device surface. In addition, newly added visualization markers are intended to enhance device placement for optimal sealing around the LAA. This device is also available in a new 40mm size option, which will enable physicians to treat a broader range of anatomies with the WATCHMAN technology.
FDA Grants Xenex Authorization for LightStrike+ UV Robot via De Novo – First & Only Microbial Reduction Robot for Healthcare Facilities
LightStrike+ devices are intended to perform microbial reduction on non-critical medical device surfaces free from visual soiling in the healthcare environment following manual cleaning and disinfection practices. They are authorized for use in healthcare facilities, including unoccupied operating rooms, hospital rooms, and other clinical settings where non-critical medical devices may be present.
Gynecological Health Company Daye Receives FDA Clearance For Its Nude Tampon
“This achievement marks a pivotal moment in our mission to enhance the health and well-being of women and AFAB individuals. Our Nude Tampon underwent rigorous evaluation before its approval, demonstrating the product's safety and performance,” said Valentina Milanova, founder and CEO of Daye.
BionicM Earns FDA Registration and Class II Exempt Device Listing for Bio Leg™; Its New Motor-Robotic Prosthetic Knee
"Bio Leg™ is a groundbreaking prosthetic knee joint which can help improve the daily activities of limb loss in transfemoral patients. We have done several trial fittings in my New York facility with very good results," says Gary Marano, CPO, LPO and CEO of OTF Prosthetics and Orthotics in New York. "Bio Leg™ allows a more natural gait to walk long distances more efficiently along with stability using ramps and inclines. Another functional benefit is to provide an easier sit to stand feature giving the user a quicker and smoother transition when standing up from a chair."
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