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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.
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."
AusperBio Announces FDA Clearance of IND Application of AHB-137 in Chronic Hepatitis B Treatment
"The FDA's clearance of our IND application to initiate clinical evaluation of AHB-137 in CHB patients in the United States brings us one step closer to introducing a potential functional cure for people living with HBV." said AusperBio CEO and Co-founder Dr. Guofeng Cheng, "This milestone is a pivotal juncture for AusperBio, underscoring our consistent and outstanding execution in driving innovative therapies towards a functional cure for CHB."
Janssen Submits Supplemental Biologics License Application to the U.S. Food and Drug Administration Seeking Approval of RYBREVANT® (amivantamab-vmjw) in Combination with Chemotherapy for the...
"PAPILLON is the first randomized Phase 3 study in patients with NSCLC with EGFR exon 20 insertion mutations to show clinically meaningful results. This creates an opportunity to make a significant improvement to the standard of care for this patient population with high unmet medical need," said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. "We look forward to working with the FDA through the RTOR pathway in pursuit of an approval for RYBREVANT plus chemotherapy as we simultaneously progress the development of this novel bispecific antibody in additional patient populations."
Levita® Magnetics Wins FDA Clearance for Pioneering MARS System
The Levita MARS system is a first-of-its-kind minimally invasive surgical platform aimed at the high-volume abdominal surgery market. Harnessing the power of both magnets and machines, MARS reduces the number of incisions and enables surgeons to have complete control during laparoscopic procedures, all in a compact footprint designed to fit into existing operating rooms.
Telesair’s Bonhawa High Flow Oxygen Receives Approval from Thai FDA
Bonhawa High Flow Oxygen device features an extended flow range up to 80 L/pm, a simple disinfection process and an easy-to-use touchscreen, allowing greater therapeutic range, efficient disinfection and the ability to visualize patient settings and data from outside the room.
Movano Health Achieves Major Milestone with First FDA Filing for Evie Ring’s Pulse Oximeter
"From the outset, our vision for Evie has been to develop a consumer wearable that is beautiful, accessible and personalized, as well as be cleared by the FDA as a medical device. This first submission to the FDA marks a momentous milestone for our team and sets the stage for future FDA filings," said John Mastrototaro, CEO of Movano Health.
Genesis MedTech Announces FDA Breakthrough Device Designation for the J-Valve™ Transfemoral System
This novel technology is designed for patients with aortic valvular disease. Aortic regurgitation is a common condition that can lead to heart failure. The J-Valve™ transcatheter aortic valve replacement procedure is performed through a minimally invasive transvascular approach, without the need for open-heart procedure or extracorporeal circulation.
Sirius Medical Announces Pintuition Probe Resterilization Clearance
Pintuition is a surgical marker navigation system that provides surgeons with both distance and direction to non-palpable tumors with exceptional accuracy. Patients benefit from enhanced diagnostic accuracy, reduced procedure times, and improved treatment planning.